IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A POLYFLEX TRACHEOBRONCHIAL STENT WAS USED DURING A STENTING PROCEDURE WITHIN THE TRACHEA ON (B)(6) 2010. ACCORDING TO THE COMPLAINANT, THE PATIENT'S ANATOMY WAS NOT TORTUOUS AND THE LESION HAD NOT BEEN PREDILATED. AFTER IMPLANTING THE STENT, THE PHYSICIAN NOTED THAT THE STENT WAS FOLDED UPON ITSELF. THE PHYSICIAN CANNOT STATE WHEN THE FOLD HAPPENED; ONLY THAT HE NOTICED IT AFTER DEPLOYMENT. THE PHYSICIAN REMOVED THE STENT FROM THE PATIENT. THE PHYSICIAN TRIED TO RELOAD THE STENT INTO THE INTRODUCER SYSTEM, BUT WAS UNABLE TO LOAD IT WITHOUT A FOLD. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. RADIO-CHEMO THERAPY WAS PERFORMED ON THE PATIENT WITH GOOD RESULTS. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.
N
Patient 1
(B)(4) - PATIENT UNDERWENT RADIO CHEMOTHERARPY. THE COMPLAINT DEVICE HAS BEEN RECEIVED BY THE MANUFACTURER; HOWEVER, A FAILURE ANALYSIS HAS NOT YET BEEN COMPLETED. UPON RECEIPT OF THE FAILURE ANALYSIS, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.
D
Patient 1
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A POLYFLEX TRACHEOBRONCHIAL STENT WAS USED DURING A STENTING PROCEDURE WITHIN THE TRACHEA ON (B)(6), 2010. ACCORDING TO THE COMPLAINANT, THE PATIENT'S ANATOMY WAS NOT TORTUOUS AND THE LESION HAD NOT BEEN PREDILATED. AFTER IMPLANTING THE STENT, THE PHYSICIAN NOTED THAT THE STENT WAS FOLDED UPON ITSELF. THE PHYSICIAN CANNOT STATE WHEN THE FOLD HAPPENED; ONLY THAT HE NOTICED IT AFTER DEPLOYMENT. THE PHYSICIAN REMOVED THE STENT FROM THE PATIENT. THE PHYSICIAN TRIED TO RELOAD THE STENT INTO THE INTRODUCER SYSTEM, BUT WAS UNABLE TO LOAD IT WITHOUT A FOLD. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. RADIO-CHEMO THERAPY WAS PERFORMED ON THE PATIENT WITH GOOD RESULTS. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.
N
Patient 1
BOTH THE STENT AND DELIVERY SYSTEM WERE RETURNED FOR ANALYSIS. THE RETURNED STENT CORRESPONDED TO A POLYFLEX DEVICE WITH A UPN OF (B)(4) (20MM INNER DIAMETER), WHILE THE DELIVERY SYSTEM CORRESPONDED TO A POLYFLEX DEVICE WITH A UPN OF (B)(4) (18MM INNER DIAMETER). WHILE THE DELIVERY SYSTEM DID NOT PRESENT WITH ANY ANOMALIES, A VISUAL EXAMINATION OF THE STENT FOUND THAT THE EDGES WERE MASHED AND DESTROYED. DUE TO THIS DAMAGE, A FUNCTIONAL EVALUATION COULD NOT BE PERFORMED. THE MOST PROBABLE ROOT CAUSE OF THIS ISSUE CANNOT BE CONFIRMED. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED; NO ANOMALIES WERE NOTED. A SEARCH OF THE COMPLAINT DATABASE REVEALED THAT NO SIMILAR COMPLAINTS EXIST FOR THE SPECIFIED LOT. A LABELING REVIEW WAS PERFORMED AND NO DEVIATION WAS FOUND.