IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A POLYFLEX TRACHEOBRONCHIAL STENT WAS USED DURING A STENT PLACEMENT PROCEDURE IN THE TRACHEA, PERFORMED ON (B)(6), 2010. ACCORDING TO THE COMPLAINANT, DURING PREPARATION, THERE WAS DIFFICULTY EXPERIENCED IN REMOVING THE BASKET FROM THE LOADING DEVICE WITHOUT REMOVING THE STENT AS WELL. DURING THE ATTEMPT, THE STENT AND THE LOADING DEVICE ENFOLDED AND BECAME UNUSABLE. THE PROCEDURE WAS COMPLETED WITH ANOTHER POLYFLEX STENT. 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 "FINE".
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Patient 1
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A POLYFLEX TRACHEOBRONCHIAL STENT WAS USED DURING A STENT PLACEMENT PROCEDURE IN THE TRACHEA, PERFORMED ON (B)(6) 2010. ACCORDING TO THE COMPLAINANT, DURING PREPARATION, THERE WAS DIFFICULTY EXPERIENCED IN REMOVING THE BASKET FROM THE LOADING DEVICE WITHOUT REMOVING THE STENT AS WELL. DURING THE ATTEMPT, THE STENT AND THE LOADING DEVICE ENFOLDED AND BECAME UNUSABLE. THE PROCEDURE WAS COMPLETED WITH ANOTHER POLYFLEX STENT. 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 "FINE".
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Patient 1
PT: UNKNOWN; HOWEVER OVER 18 YEARS OLD. (B)(4) (STENT, CRIMPING PROBLEM). 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 INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.
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Patient 1
THE RETURNED STENT AND DELIVERY SYSTEM WERE INTACT WITH NO OBVIOUS SIGNS OF CONTAMINATION, DISCOLORATION, MISSING PARTS OR DESIGN IRREGULARITIES. FUNCTIONALLY, THE STENT COULD BE LOADED WITHOUT ISSUE. ALSO, DEPLOYMENT WAS SMOOTH WITH NO KINKS OR FOLDS OBSERVED ON EITHER THE STENT OR DELIVERY SYSTEM. THE CONDITION OF THE RETURNED DEVICE WAS NOT CONSISTENT WITH THE COMPLAINT OF DIFFICULTY PREPPING THE DEVICE; THE COMPLAINT WAS NOT 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.