1570218|1615519|Y|B|1|01/04/2010|"EPIC SELF-EXPAND 1570218|1615519|Y|B|1|01/04/2010|"EPIC SELF-EXPAND

IT WAS REPORTED THAT DURING AN ILIAC STENTING PROCEDURE, STENT DEPLOYMENT DIFFICULTIES, STENT POSITIONING DIFFICULTIES AND STENT MIGRATION OCCURRED. THE LESION WAS LOCATED IN THE ILIAC ARTERY. LESION DETAILS ARE UNK. THE EPIC STENT 9X99MM WAS ADVANCED TO THE LESION AND PLACED IN POSITION WITH THE DISTAL MARKERS AT THE ILIAC BIFURCATION. THE FIRST 10MM OF THE STENT WAS DEPLOYED. "THE CONSULTANT WAS UNHAPPY WITH THE POSITION OF THE STENT, SO THE ENTIRE SYSTEM WAS PULLED BACK SLIGHTLY." THE STENT WAS THEN DEPLOYED. AS SEEN ON FLUOROSCOPY, THE STENT MIGRATED INTO THE AORTA AND REMAINED THERE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH ANOTHER OF THE SAME STENT. NO FURTHER PT COMPLICATIONS WERE REPORTED. THE PT'S STATUS IS UNK.

THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFO FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

(B) (6); (B) (4).

DEVICE EVALUATION BY MANUFACTURER: THE RETURNED PRODUCT CONSISTED OF THE EPIC VASCULAR DEVICE WITH BLOOD ON THE OUTER SURFACES OF THE DEVICE. THE STENT WAS NOT RETURNED. VISUAL/MICROSCOPIC AND TACTILE INSPECTION OF THE DEVICE REVEALED NO IRREGULARITIES. THE FLOATING AND FIXED BUMPER TIPS WERE INTACT AND DID NOT REVEAL ANY DAMAGE. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL / PROCEDURAL FACTORS. (B) (4)

IT WAS REPORTED THAT DURING AN ILIAC STENTING PROCEDURE, STENT DEPLOYMENT DIFFICULTIES, STENT POSITIONING DIFFICULTIES AND STENT MIGRATION OCCURRED.THE LESION WAS LOCATED IN THE ILIAC ARTERY. LESION DETAILS ARE UNKNOWN. THE EPIC STENT 9X99MM WAS ADVANCED TO THE LESION AND PLACED IN POSITION WITH THE DISTAL MARKERS AT THE ILIAC BIFURCATION. THE FIRST 10MM OF THE STENT WAS DEPLOYED. "THE CONSULTANT WAS UNHAPPY WITH THE POSITION OF THE STENT, SO THE ENTIRE SYSTEM WAS PULLED BACK SLIGHTLY." THE STENT WAS THEN DEPLOYED. AS SEEN ON FLUOROSCOPY, THE STENT MIGRATED INTO THE AORTA AND REMAINED THERE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH ANOTHER OF THE SAME STENT. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED. THE PATIENT STATUS IS UNKNOWN.IT WAS FURTHER REPORTED THAT THE STENOSIS WAS "APPROXIMATELY 70%." THE ILIAC ARTERY WAS MODERATELY CALCIFIED. PRIOR TO FULL DEPLOYMENT, THE DISTAL END OF THE STENT WAS "PROTRUDING TOO FAR INTO THE AORTA." THE PATIENT CONDITION WAS REPORTED AS "STABLE".THIS PRODUCT IS ONLY OUS APPROVED BUT IS SIMILAR TO AN APPROVED US DEVICE.

IT WAS REPORTED THAT DURING AN ILIAC STENTING PROCEDURE, STENT DEPLOYMENT DIFFICULTIES, STENT POSITIONING DIFFICULTIES AND STENT MIGRATION OCCURRED.THE LESION WAS LOCATED IN THE ILIAC ARTERY. LESION DETAILS ARE UNKNOWN. THE EPIC STENT 9X99MM WAS ADVANCED TO THE LESION AND PLACED IN POSITION WITH THE DISTAL MARKERS AT THE ILIAC BIFURCATION. THE FIRST 10MM OF THE STENT WAS DEPLOYED. "THE CONSULTANT WAS UNHAPPY WITH THE POSITION OF THE STENT, SO THE ENTIRE SYSTEM WAS PULLED BACK SLIGHTLY." THE STENT WAS THEN DEPLOYED. AS SEEN ON FLUOROSCOPY, THE STENT MIGRATED INTO THE AORTA AND REMAINED THERE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH ANOTHER OF THE SAME STENT. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED. THE PATIENT'S STATUS IS UNKNOWN.IT WAS FURTHER REPORTED THAT THE STENOSIS WAS "APPROXIMATELY 70%." THE ILIAC ARTERY WAS MODERATELY CALCIFIED. PRIOR TO FULL DEPLOYMENT, THE DISTAL END OF THE STENT WAS "PROTRUDING TOO FAR INTO THE AORTA." THE PATIENT'S CONDITION WAS REPORTED AS "STABLE".