POLYFLEX AIRWAY STENT SETS

Additional Manufacturer Narrative

(B)(4). INVESTIGATION RESULTS: A POLYFLEX AIRWAY STENT AND DELIVERY SYSTEM COMPONENTS WERE RETURNED FOR ANALYSIS. THE VISUAL EXAMINATION OF THE RETURNED STENT SHOWED SIGNS OF CONTAMINATION AND USAGE. THE GRADUATION MARKS ON THE DEVICE WERE CLEARLY VISIBLE. THE BASKET OF THE STENT LOADER WAS KINKED WHICH WAS MOST LIKELY CAUSED BY PACKAGING OF THE DEVICE WHEN RETURNED FOR INVESTIGATION. THE RETURNED STENT LOADER, DELIVERY TUBE AND STENT SHOWED SEVERAL DAMAGES. FUNCTIONAL EVALUATION FOUND THE STENT COULD BE LOADED AND RELEASED ACCORDING TO THE PROCEDURE WITH THE RETURNED COMPONENTS. NO OTHER ISSUES WERE NOTED WITH THE DEVICE. THE NOTED DAMAGES TO THE RETURNED DEVICE WERE LIKELY DUE TO ANATOMICAL OR PROCEDURAL FACTORS, SUCH AS TIGHT ANATOMY, ENCOUNTERED DURING THE PROCEDURE, WHICH LIMITED THE PERFORMANCE OF THE DEVICE. THEREFORE, THE MOST PROBABLE ROOT CAUSE FOR THIS COMPLAINT IS OPERATIONAL CONTEXT. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED AND CONFIRMED THAT THIS DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS AT THE TIME OF RELEASE FOR DISTRIBUTION. A SEARCH OF THE COMPLAINT DATABASE CONFIRMED THAT NO OTHER SIMILAR COMPLAINTS EXIST FOR THE SPECIFIED LOT.

Description of Event or Problem

NOTE: THIS MANUFACTURER REPORT PERTAINS TO ONE OF TWO DEVICES USED IN THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT # 3005099803-2017-03619 AND 3005099803-2017-03620 FOR THE ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO POLYFLEX AIRWAY STENTS WAS WERE TO BE USED IN THE TRACHEA TO TREAT AN APPROXIMATELY 3MM POST INTUBATION STRICTURE DURING BRONCHOSCOPY WITH STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2017. REPORTEDLY, THE PATIENT'S ANATOMY WAS TIGHT AND WAS DILATED PRIOR TO STENT PLACEMENT. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED DIFFICULTY PASSING THE FIRST DELIVERY SYSTEM (THE SUBJECT OF MFR REPORT # 3005099803-2017-03619) THROUGH THE STRICTURE. THE DELIVERY SYSTEM BENT AND PHYSICIAN DEEMED IT UNUSABLE. THE PHYSICIAN REMOVED THE STENT DELIVERY SYSTEM FROM THE PATIENT AND USED A SECOND, SMALLER-SIZED POLYFLEX AIRWAY STENT (THE SUBJECT OF THIS REPORT); THE SAME ISSUE WAS ENCOUNTERED ON THE SECOND DELIVERY SYSTEM AND WAS ALSO DEEMED UNSUABLE. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. 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. NOTE: THIS HAS BEEN DEEMED AN MDR-REPORTABLE EVENT BASED ON INVESTIGATION RESULTS WHICH REVEALED THAT THE STENT WAS DAMAGED.