74MAF ABBOTT VASCULAR-CARDIAC THERAPIES

REPORTING STATUS: SERIOUS INJURY. REPORTING RATIONALE: DISLODGED STENT REMAINS FREE FLOATING IN THE PT ANATOMY. DEVICE ISSUE: STENT DISLODGEMENT. IT WAS REPORTED THAT THE MID CIRCUMFLEX (CX) ARTERY WAS VERY TORTUOUS IN AN IN-STENT RESTENOSED (ISR) VESSEL OF AN UNK DRUG ELUTING STENT IMPLANTED 5 YEARS AGO. A 7F XB3.5 GUIDE CATHETER WAS USED AND A BMW U 11 WAS TRACKED INTO THE BLOCKED ISR AFTER STRUGGLING FOR 5 MINUTES. A RYUJIN OF 1.25-10MM WAS USED TO PRE-DILATE THE BLOCKED VESSEL. THE FLOW WAS MUCH IMPROVED AND A 2.0 X 12 MM MINI VISION STENT DELIVERY SYSTEM (SDS) WAS USED SEVERAL TIMES TO ADVANCE THE SDS TO THE MID BLOCKED CX, BUT THE STENT DISLODGED ALONG THE HEAVILY CALCIFIED VESSEL. THE DISLODGED STENT WAS NOT FOUND. ANOTHER MINI VISION SDS WAS USED, BUT THE STENT DID NOT CROSS TO THE MID BLOCKED CX. A VOYAGER WAS USED TO PRE-DILATE THE VESSEL TWICE AT 16 ATM FOR 15 SECONDS. A MINI VISION AND TWO VISION STENTS WERE USED OVERLAPPING EACH OTHER TO COVER THE ENTIRE BLOCKED VESSEL WITH MUCH DIFFICULTY. THESE STENTS WERE FINALLY DEPLOYED AT 16 ATM FOR 10 SECONDS EACH AND POST DILATED WITH A NC VOYAGER AT 20 ATM FOR 5 SECONDS. NO ADDITIONAL EVENT OR PT INFO IS AVAILABLE.

(B) (4). (B) (4). PRODUCT PERFORMANCE ENGINEERING WAS UNABLE TO PERFORM AN EVAL AT THE TIME OF THIS REPORT. EVAL SUMMARY: QUALITY ASSURANCE ANALYSIS REVEALED THAT THE STENT DELIVERY SYSTEM (SDS) WAS RETURNED WITH BLOOD IN THE GUIDE WIRE LUMEN. THERE WAS CONTRAST ON THE BALLOON AND ON THE OUTER MEMBER. THE STENT IMPLANT WAS DISLODGED FROM THE BALLOON AND LOCATED LOOSE ON THE DISTAL SHAFT. THERE WERE FLARED STRUTS IN THE FIRST AND SECOND ROW AT THE DISTAL END OF THE STENT IMPLANT. THERE WAS NO OTHER DAMAGE NOTED TO THE STENT IMPLANT. THE BALLOON WAS TIGHTLY FOLDED. THERE WERE CRIMP MARKS ON THE BALLOON BETWEEN THE MARKERS. THERE WERE CHATTERMARKS ON THE OUTER MEMBER, 1 CM PROXIMAL TO THE PROXIMAL SEAL FOR A LENGTH OF 1.5 CM. THERE WERE TWO KINKS IN THE HYPOTUBE, 20.5 CM AND 22 DISTAL TO THE STRAIN RELIEF TUBING. THERE WERE NO KINKS OR DAMAGE NOTED TO THE TIP AND INNER MEMBER. THERE WAS NO OTHER DAMAGE NOTED TO THE SDS. THE TIP LENGTH WAS MEASURED AND THIS MET MANUFACTURING CRITERIA. A SNAP GAUGE WAS USED TO MEASURE THE OUTER DIAMETER OF THE STENT IMPLANT. THE STENT IMPLANT OUTER DIAMETER MEASUREMENTS WERE OVERSIZED AND THESE DID NOT MEET MANUFACTURING CRITERIA. PRODUCT PERFORMANCE ENGINEERING WAS UNABLE TO PERFORM AN EVAL AT THE TIME OF THIS REPORT. RESULTS AND CONCLUSIONS WILL BE FORWARDED UPON COMPLETION.

REPORTING STATUS: MALFUNCTION. REPORTING RATIONALE: STENT DISLODGEMENT HAS CAUSED OR CONTRIBUTED TO PT INJURY PREVIOUSLY. DEVICE ISSUE: STENT DISLODGEMENT. IT WAS REPORTED THAT THE 4.0 X 23 MM MULTI-LINK VISION RX WAS USED IN AN INTERVENTIONAL PROCEDURE IN AN UNSPECIFIED TARGET VESSEL. THE STENT DELIVERY SYSTEM WAS INSERTED IN THE PT'S VASCULATURE AND WHEN THE BALLOON WAS INFLATED FOR STENT DEPLOYMENT, THE STENT COULD NOT BE LOCATED. THE STENT WAS FOUND ON THE STYLET STILL IN THE PACKAGING. THERE WAS NO PT EFFECT REPORTED. NO ADDITIONAL EVENT OR PT INFO IS AVAILABLE.

(B) (4)

REPORTING STATUS: SERIOUS INJURY- MEDICAL INTERVENTION/PERMANENT DAMAGE. REPORTING RATIONALE: STENT REMAINS IN PATIENT AT UNINTENDED SITE. DEVICE ISSUE: STENT DISLODGEMENT. IT WAS REPORTED THE 2.25 X 08 MM RX MINI VISION STENT DELIVERY SYSTEM (SDS) WAS ADVANCED, BUT WAS UNABLE TO CROSS THE PRE-DILATED LESION. UPON REMOVAL, THE STENT DISLODGED. THE STENT REMAINED ON THE GUIDE WIRE, SO A BALLOON CATHETER WAS ADVANCED AND DEPLOYED THE STENT IN THE PROXIMAL DIAGONAL (UNINTENDED SITE). NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE.

(B) (4). (B) (4). EVALUATION SUMMARY: QUALITY ASSURANCE ANALYSIS REVEALED THAT THE STENT DELIVERY SYSTEM (SDS) WAS RETURNED WITH BLOOD VISIBLE ON THE BALLOON AND IN THE GUIDE WIRE LUMEN. THERE WAS CONTRAST ON THE BALLOON, SHAFT AND IN THE INFLATION LUMEN AND IN THE BALLOON. THE STENT IMPLANT HAD DISLODGED FROM THE BALLOON AND WAS NOT RETURNED. THE BALLOON WAS TIGHTLY FOLDED. THERE WERE CRIMP MARKS ON THE BALLOON BETWEEN THE MARKERS. THERE WAS NO OTHER DAMAGE NOTED TO THE SDS. THE PROTECTIVE SHEATH AND STYLET WERE NOT RETURNED. THE TIP LENGTH WAS MEASURED AND MET MANUFACTURING CRITERIA. PRODUCT PERFORMANCE ENGINEERING REVIEWED THE INCIDENT INFORMATION AND ANALYSIS OF THE RETURNED PRODUCT. QUALITY ASSURANCE TECHNICIAN ANALYSIS OF THE RETURNED PRODUCT NOTED BLOOD VISIBLE ON THE BALLOON AND IN THE GUIDE WIRE LUMEN. THERE WAS CONTRAST ON THE BALLOON, SHAFT, AND IN THE INFLATION LUMEN AND BALLOON. THIS IS CONSISTENT WITH PREPARATION AND THE SDS ADVANCED OVER A GUIDE WIRE INTO THE PATIENT ANATOMY. THE INABILITY TO CROSS A LESION CAN BE AFFECTED BY NUMEROUS FACTORS INCLUDING, BUT NOT LIMITED TO, PATIENT ANATOMICAL MORPHOLOGY, PATIENT DISEASE STATE, PRE-DILATATION STRATEGY, DEVICE PLACEMENT TECHNIQUE, AND ACCESSORY DEVICE SUPPORT. THE TIP LENGTH WAS MEASURED AND MET MANUFACTURING CRITERIA. REPORTEDLY, THE TARGET LESION WAS VERY TORTUOUS AND HEAVILY CALCIFIED, WHICH LIKELY CONTRIBUTED TO THE REPORTED FAILURE TO ADVANCE. THE STENT WAS DISLODGED FROM THE BALLOON AND NOT RETURNED, CONFIRMING THE REPORTED DISLODGEMENT. CRIMP MARKS WERE VISIBLE ON THE TIGHTLY FOLDED BALLOON BETWEEN THE MARKERS, SUGGESTING THAT THE STENT WAS ORIGINALLY POSITIONED CORRECTLY AND SECURELY AT THE TIME OF MANUFACTURE. IN THIS CASE, IT IS LIKELY THAT DURING THE ATTEMPTS TO CROSS THE TORTUOUS AND CALCIFIED LESION, THE STENT LIKELY LOOSENED SUCH THAT AS FORCE WAS APPLIED, THE STENT DISLODGED. THE REPORTED NONRESORBABLE MATERIAL UNRETRIEVED IN THE BODY IS A SECONDARY EFFECT OF THE DISLODGED STENT DEPLOYED IN AN UNINTENDED LOCATION. THE MANUFACTURING RECORDS WERE REVIEWED AND DID NOT REVEAL ANY NON-CONFORMANCES FOR THIS LOT THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT AND ALL LOT RELEASE TESTING MET SPECIFICATION. IN THIS CASE, THE REPORTED FAILURE TO ADVANCE, DISLODGEMENT AND NONRESORBABLE MATERIAL UNRETRIEVED IN THE BODY APPEAR TO BE RELATED TO THE OPERATIONAL CONTEXT OF THE PROCEDURE. PRODUCT PERFORMANCE ENGINEERING WILL MONITOR THE INCIDENT CIRCUMSTANCES. ALL STENT DELIVERY SYSTEMS ARE 100% VISUALLY INSPECTED ONLINE FOR STENT PLACEMENT. ADDITIONALLY, A SAMPLING OF UNITS IS DESTRUCTIVELY TESTED TO VERIFY STENT DISLODGEMENT FORCE. THIS MDR IS CONSIDERED CLOSED BY THE PRODUCT PERFORMANCE GROUP.

REPORTING RATIONALE: MALFUNCTION. REPORTING STATUS: A DISLODGED STENT HAS CAUSED OR CONTRIBUTED TO PATIENT INJURY PREVIOUSLY. DEVICE ISSUE: DISLODGED STENT. IT WAS REPORTED THAT DURING TREATMENT OF A HEAVILY CALCIFIED, HEAVILY TORTUOUS, PROXIMAL CIRCUMFLEX ARTERY, AFTER PRE-DILATATION, THE VISION STENT DELIVERY SYSTEM WAS ADVANCED, BUT WOULD NOT CROSS THE TARGET LESION. WHEN THE DEVICE WAS REMOVED, IT WAS NOTICED THAT THE STENT HAD DISLODGED OFF THE STENT DELIVERY SYSTEM IN THE PATIENT'S ANATOMY. AN UNSPECIFIED SNARE DEVICE WAS USED TO REMOVE THE DISLODGED STENT. A XIENCE V STENT WAS SUCCESSFULLY IMPLANTED IN THE TARGET LESION. THERE WERE NO REPORTED PATIENT COMPLICATIONS OR ADVERSE EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

(B) (4).

REPORTING STATUS: SERIOUS INJURY - MEDICAL INTERVENTION. REPORTING RATIONALE: DEVICE REMAINS IN PATIENT. DEVICE ISSUE: STENT DISLODGEMENT. IT WAS REPORTED THAT THE MULTI LINK MINI VISION RX STENT DISLODGED FROM THE BALLOON DURING AN ATTEMPT TO PLACE THE STENT DISTAL TO AN EXISTING STENT IN THE CIRCUMFLEX ARTERY. AN ATTEMPT WAS MADE TO RETRIEVE THE STENT USING AN UNSPECIFIED BALLOON; HOWEVER, IT WAS UNSUCCESSFUL. THE ATTEMPT DID MANAGE TO MOVE THE STENT INTO A SIDE BRANCH, WHERE IT REMAINS. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE.

EVALUATION SUMMARY: ANALYSIS OF THE STENT DELIVERY SYSTEM (SDS) CONFIRMED THAT THE STENT IMPLANT WAS DISLODGED AND NOT RETURNED; HOWEVER, THERE WERE CRIMP MARKS EVIDENT ON THE BALLOON BETWEEN THE MARKERS, INDICATING THAT THE STENT WAS ORIGINALLY POSITIONED CORRECTLY AND SECURE AT THE TIME OF MANUFACTURE. THERE WAS CONTRAST VISIBLE IN THE INFLATION LUMEN AND ON THE BALLOON, WHICH INDICATES THAT SDS HAD BEEN PREPARED FOR USE. ADDITIONALLY, THE BALLOON FOLDS APPEARED TO BE RELAXED, WHICH SUGGESTS POSITIVE PRESSURE MAY HAVE BEEN APPLIED TO THE SYSTEM, FORCING THE BALLOON TO SLIGHTLY EXPAND. IF SIGNIFICANT PRESSURE IS INADVERTENTLY APPLIED DURING THE PROCEDURE, THIS CAN CAUSE THE STENT TO BECOME DISRUPTED ON THE BALLOON. THIS MAY HAVE THEN FACILITATED STENT DISLODGEMENT DURING ATTEMPTED ADVANCEMENT AND RETRACTION THROUGH A PREVIOUSLY IMPLANTED STENT AND/OR THE TORTUOUS LESION, THOUGH THIS CANNOT BE CONFIRMED. TO ENSURE THIS TYPE OF OCCURRENCE IS NOT A RESULT OF A POTENTIAL MANUFACTURING OR PRODUCT RELATED DEFICIENCY, ALL STENT DELIVERY SYSTEMS ARE VISUALLY INSPECTED ONLINE FOR STENT PLACEMENT/SECURITY AND DIMENSIONALLY INSPECTED TO VERIFY THE CRIMPED STENT OUTER DIAMETERS. ADDITIONALLY, A SAMPLING OF UNITS IS SUBJECTED TO A STENT MOVEMENT TEST TO VERIFY STENT SECURITY. FACTORS THAT CAN AFFECT STENT DISLODGEMENT INSIDE THE BODY INCLUDE, BUT ARE NOT LIMITED TO IMPROPER OR INADEQUATE CRIMPING AT THE TIME OF MANUFACTURE, POSITIVE PRESSURE DURING PRODUCT PREPARATION, NEGATIVE PRESSURE DURING SHEATH REMOVAL, FORCED SHEATH REMOVAL, HANDLING OF THE STENT DURING PRODUCT PREPARATION OR FROM INTERACTION WITH OTHER DEVICES, THE PATIENT'S ANATOMY AND/OR A PREVIOUSLY IMPLANTED STENT. REPORTEDLY, THE LESION WAS HEAVILY TORTUOUS AND MAY HAVE CONTRIBUTED TO THE REPORTED DIFFICULTY. THE ANALYSIS ALSO NOTED MULTIPLE BENDS IN THE HYPOTUBE DISTAL TO THE STRAIN RELIEF TUBING. HOWEVER, THIS DAMAGE WAS NOT REPORTED IN THE CASE DESCRIPTION AND MOST LIKELY OCCURRED DURING THE PROCEDURE OR AS A RESULT OF HANDLING DURING PACKAGING FOR SHIPMENT TO ABBOTT VASCULAR FOR ANALYSIS. THIS DAMAGE DOES NOT APPEAR TO BE RELATED TO OR HAVE CONTRIBUTED TO THE REPORTED DISLODGEMENT. IN THIS INSTANCE, BASED ON THE INFORMATION RECEIVED AND THE RETURNED PRODUCT ANALYSIS, THE REPORTED STENT DISLODGEMENT APPEARS TO BE RELATED TO CIRCUMSTANCE OF THE PROCEDURE AND NOT A PRODUCT QUALITY DEFICIENCY. A REVIEW OF THE DEVICE LOT HISTORY RECORD DID NOT REVEAL ANY NON-CONFORMITIES WHICH COULD HAVE CONTRIBUTED TO THIS COMPLAINT. THIS MDR IS CONSIDERED CLOSED BY THE PRODUCT PERFORMANCE GROUP.

THE SECOND MULTI-LINK RX VISION CORONARY STENT SYSTEM INDICATED IS BEING FILED UNDER THE SAME MFR NUMBER.

REPORTING STATUS: SERIOUS INJURY/MEDICAL INTERVENTION. REPORTING RATIONALE: RESTENOSIS REQUIRING MEDICAL INTERVENTION. DEVICE ISSUE: NO DEVICE MALFUNCTION HAS BEEN REPORTED. IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT INSTENT RESTENOSIS OF TWO PREVIOUSLY IMPLANTED RX VISION STENTS (3.0X28MM AND A 2.75X12MM) (2009), WITH AN ADDITIONAL XIENCE V STENT IN THE RCA; HOWEVER, IT WAS A DIFFICULT CASE, AND THE ATTEMPT TO CROSS WITH THE XIENCE V STENT WAS NOT SUCCESSFUL. THE STENT DELIVERY SYSTEM (SDS) WAS REMOVED AND ADDITIONAL PREDILATATION WAS PERFORMED. THE SAME XIENCE V WAS ADVANCED AGAIN; HOWEVER, THE STENT DISLODGED FROM THE BALLOON. THE STENT WAS ABLE TO BE RETRIEVED WITH THE SDS BALLOON SUCCESSFULLY. AFTER ADDITIONAL DILATATION WITH SEVERAL DIFFERENT BALLOON CATHETERS, ANOTHER COMPANY'S STENTS WERE ABLE TO BE DEPLOYED FOR TREATMENT, RESULTING IN A TOTAL RECONSTRUCTION OF THE RCA VESSEL. NO ADDITIONAL EVENT OR PT INFO IS AVAILABLE.

ANGINA, BRADYCARDIA, HYPOTENSION, THROMBOSIS AND DEATH, PER THE IFU, ARE KNOWN ADVERSE EVENTS ASSOCIATED WITH STENTING AND ARE NOT NECESSARILY AN INDICATION OF A PRODUCT QUALITY DEFICIENCY. POSSIBLY THE ANGINA, BRADYCARDIA, HYPOTENSION AND MYOCARDIAL INFARCTION ARE A SECONDARY EFFECT OF THE THROMBOSIS WHICH REQUIRED IMPLANT OF AN IABP AND MEDICATIONS FOR TREATMENT WHICH ULTIMATELY RESULTED IN DEATH. A CONCLUSIVE CAUSE FOR THE PT EFFECTS AND THE RELATIONSHIP TO THE PRODUCT CANNOT BE DETERMINED. THE MULTI-LINK RX VISION CORONARY STENT SYSTEM INDICATED IS BEING FILED UNDER MANUFACTURER NUMBER 2024168-2010-00059.

REPORTING STATUS: DEATH. REPORTING RATIONAL: DEATH. DEVICE ISSUE: NO DEVICE MALFUNCTION HAS BEEN REPORTED. IT WAS REPORTED THAT THE PT HAD AN 80% LESION IN THE LEFT ANTERIOR DESCENDING (LAD) AND AN 85% LESION IN THE DISTAL LEFT MAIN CORONARY ARTERY (LMCA). THE LESION WAS CROSSED USING ANOTHER COMPANY'S GUIDE WIRES. PREDILATATION WAS DONE WITH A 2 X 12 VOYAGER AND ANOTHER COMPANY'S 1.5 X 6 BALLOON. THE LESION IN THE LAD WAS COVERED BY A 2.5 X 18 MINIVISION AND THE LMCA-LAD LESION WAS COVERED BY A 3 X 15 VISION. DURING THE PROCEDURE, THE PT DEVELOPED HYPOTENSION AND BRADYCARDIA. TPI AND AN INTRA-AORTIC BALLOON PUMP (IABP) WERE INSERTED THROUGH THE LEFT FEMORAL. THE PT WAS INTUBATED AND WAS STARTED ON INOTROPES. THE PROCEDURE WAS DONE IN 2009, AND THE PT WAS DISCHARGED FOUR DAYS LATER. THE FOLLOWING DAY, THE PT DEVELOPED CHEST PAIN AND COLLAPSED ON THE WAY TO THE HOSPITAL. WHEN THE PT REACHED THE HOSPITAL, HE WAS DECLARED DEAD. THE DOCTOR MENTIONED THAT THE DEATH COULD BE BECAUSE OF STENT THROMBOSIS. THE PT WAS TAKING ASPIRIN AT THE TIME DEATH. THE DIAGNOSES OF THE ACUTE CORONARY SYNDROME AT THE TIME OF EVENT WAS A MYOCARDIAL INFARCTION (MI). NO ADD'L INFO IS AVAILABLE.

REPORTING STATUS: DEATH. REPORTING RATIONAL: DEATH. DEVICE ISSUE: NO DEVICE MALFUNCTION HAS BEEN REPORTED. IT WAS REPORTED THAT THE PT HAD AN 80% LESION IN THE LEFT ANTERIOR DESCENDING (LAD) AND AN 85% LESION IN THE DISTAL LEFT MAIN CORONARY ARTERY (LMCA). THE LESION WAS CROSSED USING ANOTHER COMPANY'S GUIDE WIRES. PREDILATATION WAS DONE WITH A 2 X 12 VOYAGER AND ANOTHER COMPANY'S 1.5 X 6 BALLOON. THE LESION IN THE LAD WAS COVERED BY A 2.5 X 18 MINIVISION AND THE LMCA-LAD LESION WAS COVERED BY A 3 X 15 VISION. DURING THE PROCEDURE, THE PT DEVELOPED HYPOTENSION AND BRADYCARDIA. TPI AND AN INTRA-AORTIC BALLOON PUMP (IABP) WERE INSERTED THROUGH THE LEFT FEMORAL. THE PT WAS INTUBATED AND WAS STARTED ON INOTROPES. THE PROCEDURE WAS DONE IN 2009, AND THE PT WAS DISCHARGED FOUR DAYS LATER. THE FOLLOWING DAY, THE PT DEVELOPED CHEST PAIN AND COLLAPSED ON THE WAY TO THE HOSPITAL. WHEN THE PT REACHED THE HOSPITAL, HE WAS DECLARED DEAD. THE DOCTOR WAS MENTIONING THAT THE DEATH COULD BE BECAUSE OF STENT THROMBOSIS. THE PT WAS TAKING ASPIRIN AT THE TIME DEATH. THE DIAGNOSES OF THE ACUTE CORONARY SYNDROME AT THE TIME OF THE EVENT WAS A MYOCARDIAL INFARCTION (MI). NO ADD'L INFO IS AVAILABLE.

ANGINA, BRADYCARDIA, HYPOTENSION, THROMBOSIS AND DEATH, AS LISTED IN THE IFU, ARE KNOWN ADVERSE EVENTS ASSOCIATED WITH CORONARY STENTING AND ARE NOT NECESSARILY AN INDICATION OF A PRODUCT QUALITY DEFICIENCY. THE PT EFFECTS ARE LISTED IN THE RISK ASSESSMENT AS NO FAULT PROCEDURAL COMPLICATIONS. POSSIBLY THE ANGINA, BRADYCARDIA, HYPOTENSION AND MYOCARDIAL INFARCTION ARE A SECONDARY EFFECT OF THE THROMBOSIS WHICH REQUIRED IMPLANT OF AN IABP AND MEDICATIONS FOR TREATMENT WHICH ULTIMATELY RESULTED IN DEATH. HOWEVER, A CONCLUSIVE CAUSE FOR THE REPORTED PT EFFECTS AND THE RELATIONSHIP TO THE PRODUCTS CANNOT BE DETERMINED.

DISSECTION, AS LISTED IN THE IFU IS A KNOWN ADVERSE EVENT ASSOCIATED WITH CORONARY STENTING. DISSECTION CAN BE INFLUENCED BY SEVERAL FACTORS, INCLUDING BUT NOT LIMITED TO, LESION CHARACTERISTICS, PROCEDURAL TECHNIQUE, AND DEVICE SIZE SELECTION. THE IFU ALSO STATES: IMPLANTING A STENT MAY LEAD TO DISSECTION OF THE VESSEL DISTAL AND/OR PROXIMAL TO THE STENT AND MAY CAUSE ACUTE CLOSURE OF THE VESSEL REQUIRING ADDITIONAL INTERVENTION. A CONCLUSIVE CAUSE FOR THE PT EFFECT, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED. THERE IS NO INDICATION OF QUALITY DEFICIENCY. THE 3.0 X 18 MM VISION IS BEING REPORTED UNDER THIS SAME MFR #.

REPORTING STATUS: SERIOUS INJURY/MEDICAL INTERVENTION. REPORTING RATIONALE: DISSECTION, REQUIRING MEDICAL INTERVENTION TO PREVENT PERMANENT IMPAIRMENT OR INJURY. DEVICE ISSUE: NO DEVICE MALFUNCTION HAS BEEN REPORTED. IT WAS REPORTED THAT AFTER PRE-DILATATION WAS PERFORMED, A 3.0 X 18 MM VISION STENT WAS DEPLOYED IN THE MID LEFT ANTERIOR DESCENDING (LAD) ARTERY AND A 3.5 X 28 MM VISION STENT WAS DEPLOYED IN THE PROXIMAL LAD. AFTER DEPLOYMENT OF THE SECOND STENT, A DISSECTION WAS NOTED IN BETWEEN THE TWO VISION STENTS. A 3.5 X 12MM VISION STENT DELIVERY SYSTEM (SDS) WAS SELECTED TO TREAT THE DISSECTION, BUT WOULD NOT CROSS THE LESION. MANY UNSUCCESSFUL ATTEMPTS WERE MADE USING ANOTHER GUIDE WIRE, DILATING THE STENTS AND REPLACING THE GUIDE CATHETER. FINALLY, ANOTHER DRUG ELUTING STENT SUCCESSFULLY CROSSED LESION AND TREATED THE DISSECTION. NO ADDITIONAL EVENT OR PT INFO IS AVAILABLE.

REPORTING STATUS: SERIOUS INJURY/MEDICAL INTERVENTION/PERMANENT DAMAGE. REPORTING RATIONALE: DISLODGED STENT COMPRESSED IN VESSEL WALL. DEVICE ISSUE: DISLODGED STENT. IT WAS REPORTED THAT THE TARGET LESION WAS MILDLY TORTUOUS AND HEAVILY CALCIFIED WITH A 99% STENOSIS. ANOTHER COMPANY'S STENT WAS IMPLANTED IN THE LEFT MAIN (LM) TO TREAT A DISSECTION. THEN PRE-DILATATION WAS DONE DISTALLY WITH A BALLOON CATHETER. A SECOND DISSECTION OCCURRED BY THE DISTAL EDGE OF THE STENT WHEN ANOTHER COMPANY'S STENT WAS IMPLANTED. A MINI VISION WAS ATTEMPTED TO DELIVER FOR BAILOUT, BUT IT BECAME CAUGHT IN TORTUOSITY AND CALCIFICATION AND WAS UNABLE TO CROSS THE LESION. SINCE THE FIRST STENT IMPLANTED IN THE LM WAS INCOMPLETE APPOSITION, IT CAUGHT IN THE STENT STRUT OF THE MINI VISION AND DISLODGED. THE STENT WAS UNABLE TO BE RETRIEVED, THUS THE MINI VISION WAS COMPRESSED WITH ANOTHER COMPANY'S STENT. POST DILATATION WAS DONE WITH A BALLOON AND ANOTHER COMPANY'S STENT WAS IMPLANTED DISTALLY. THE PROCEDURE WAS COMPLETED. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE.

PRODUCT PERFORMANCE ENGINEERING REVIEWED THE INCIDENT INFORMATION. IT IS LIKELY THAT INTERACTION WITH THE LESION/ANATOMY LIKELY LOOSENED THE STENT IMPLANT, SUCH THAT DURING REMOVAL, THE STENT INTERACTED WITH THE PREVIOUSLY IMPLANTED STENT. AS FURTHER FORCE WAS APPLIED, THE STENT DISLODGED. THE REPORTED DEVICE EMBEDDED IN VESSEL OR PLAQUE IS RELATED TO THE STENT DISLODGEMENT AS ANOTHER COMPANY'S STENT WAS USED TO CRUSH THE DISLODGED STENT IN THE VESSEL. THE REPORTED FAILURE TO ADVANCE, STENT DISLODGEMENT AND DEVICE EMBEDDED IN VESSEL/PLAQUE APPEAR TO BE RELATED TO THE OPERATIONAL CONTEXT OF THE PROCEDURE.

REPORTING STATUS: SERIOUS INJURY/MEDICAL INTERVENTION/PERMANENT DAMAGE. REPORTING RATIONALE: DISLODGED STENT COMPRESSED IN VESSEL WALL. DEVICE ISSUE: DISLODGED STENT. IT WAS REPORTED THAT THE TARGET LESION WAS MILDLY TORTUOUS AND HEAVILY CALCIFIED WITH A 99% STENOSIS. ANOTHER COMPANY'S STENT WAS IMPLANTED IN THE LEFT MAIN (LM) TO TREAT A DISSECTION. THEN PRE-DILATATION WAS DONE DISTALLY WITH A BALLOON CATHETER. A SECOND DISSECTION OCCURRED BY THE DISTAL EDGE OF THE STENT WHEN ANOTHER COMPANY'S STENT WAS IMPLANTED. A MINI VISION WAS ATTEMPTED TO DELIVER FOR BAILOUT, BUT IT BECAME CAUGHT IN TORTUOSITY AND CALCIFICATION AND WAS UNABLE TO CROSS THE LESION. SINCE THE FIRST STENT IMPLANTED IN THE LM WAS INCOMPLETE APPOSITION, IT CAUGHT IN THE STENT STRUT OF THE MINI VISION AND DISLODGED. THE STENT WAS UNABLE TO BE RETRIEVED, THUS THE MINI VISION WAS COMPRESSED WITH ANOTHER COMPANY'S STENT. POST DILATATION WAS DONE WITH A BALLOON AND ANOTHER COMPANY'S STENT WAS IMPLANTED DISTALLY. THE PROCEDURE WAS COMPLETED. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE.

PRODUCT PERFORMANCE ENGINEERING REVIEWED THE INCIDENT INFORMATION. IT IS LIKELY THAT INTERACTION WITH THE LESION/ANATOMY LIKELY LOOSENED THE STENT IMPLANT, SUCH THAT DURING REMOVAL, THE STENT INTERACTED WITH THE PREVIOUSLY IMPLANTED STENT. AS FURTHER FORCE WAS APPLIED, THE STENT DISLODGED. THE REPORTED DEVICE EMBEDDED IN VESSEL OR PLAQUE IS RELATED TO THE STENT DISLODGEMENT AS ANOTHER COMPANY'S STENT WAS USED TO CRUSH THE DISLODGED STENT IN THE VESSEL. THE REPORTED FAILURE TO ADVANCE, STENT DISLODGEMENT AND DEVICE EMBEDDED IN VESSEL/PLAQUE APPEAR TO BE RELATED TO THE OPERATIONAL CONTEXT OF THE PROCEDURE.