POLYFLEX AIRWAY STENT SETS

Additional Manufacturer Narrative

PATIENT'S EXACT AGE IS UNKNOWN; HOWEVER IT WAS REPORTED THAT THE PATIENT WAS OVER THE AGE OF 18. THE COMPLAINANT WAS UNABLE TO PROVIDE THE DEVICE LOT NUMBER. THEREFORE, THE MANUFACTURE AND EXPIRATION DATES ARE UNKNOWN. (B)(4). ACCORDING TO THE COMPLAINANT, THE SUSPECT DEVICE HAS BEEN RETAINED AND IS NOT AVAILABLE FOR RETURN. IF ANY FURTHER RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL MDR WILL BE FILED.

Description of Event or Problem

IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON MAY 1, 2017 THAT A POLYFLEX AIRWAY STENT WAS IMPLANTED THROUGH PREVIOUSLY PLACED NITINOL UNCOVERED STENT TO TRY TO PREVENT FURTHER INGROWTH OF GRANULATION TISSUE IN THE TRACHEA DURING A STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2016. THE PATIENT HAD RECEIVED 2 OR 3 PREVIOUS UNCOVERED NITINOL STENTS OVER THE PAST 15 YEARS TO TREAT AN UNDERLYING CONDITION OF BENIGN FOCAL TRACHEOMALACIA FOLLOWING A THYROIDECTOMY. FOR THE PAST 5 YEARS THE PATIENT HAD BEEN DEVELOPING WORSENING STRIDOR. THE PREVIOUS STENTS HAD COMPLETELY BROKEN DOWN AND GRANULATION TISSUE WAS NEARLY TOTALLY OCCLUDING THE AIRWAY. DEBRIDEMENT OF THE TISSUE WAS PERFORMED 4 TIMES BUT THE TISSUE GRANULATION WOULD RECUR WITHIN WEEKS. REPORTEDLY, FOLLOWING THE IMPLANTATION OF THE POLYFLEX STENT THE PATIENT EXPERIENCED NEAR COMPLETE SYMPTOM CONTROL. ACCORDING TO THE COMPLAINANT, THE PATIENT EXPERIENCED A RAPID ONSET OF BREATHLESSNESS AND STRIDOR ON (B)(6) 2017. AN ELECTIVE BRONCHOSCOPY WAS PERFORMED ON (B)(6) 2017 AND THE PHYSICIAN NOTED THAT THE INNER SILICON LINING OF THE STENT APPEARED TO HAVE SEPARATED FROM THE OUTER MESH AND WAS PARTIALLY OBSTRUCTING THE STENT. THE PHYSICIAN USED A MICRODEBRIDER TO REMOVE THE PROTRUDING MATERIAL, THE LINING WAS BROKEN INTO SMALL PIECES AND SUCTIONED FROM THE PATIENT, AND THE STENT'S LUMEN PATENCY WAS RESTORED. REPORTEDLY, THE STENT IS SCHEDULED TO BE REMOVED ON (B)(6) 2017. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE. ACCORDING TO THE PHYSICIAN, HE WAS NOT SURE IF THE DAMAGE TO THE STENT LINING WAS A DEVICE MALFUNCTION OR WHETHER IT COULD HAVE BEEN DUE TO THE INHALED NEBULIZED N-ACETYLCYSTEIN (400 MG BD) THE PATIENT WAS PRESCRIBED AS PART OF ROUTINE SECRETION MANAGEMENT.

Additional Manufacturer Narrative

A DEPLOYED POLYFLEX TRACHEOBRONCHIAL STENT WAS RETURNED FOR ANALYSIS; THE SET COMPONENTS WERE NOT RETURNED. VISUAL EVALUATION OF THE RETURNED DEVICE FOUND SLIGHT DISCOLORATION ON THE STENT BUT NO DESIGN IRREGULARITIES. AT ONE END OF THE STENT, THE MESH WAS EXPOSED AS WELL AS THE CROWN ENDING (SILICONE DRIPS AT THE END OF THE MESH) AND THE RADIOPAQUE MARKERS WERE PARTIALLY MISSING. IN THE MIDDLE OF THE STENT, THE MAIN SILICONE COATING WAS ALSO MISSING. NO OTHER ISSUES WERE IDENTIFIED WITH THE DEVICE. IT WAS REPORTED THAT THE ANATOMY LOCATION OF STENT PLACEMENT WAS VERY COMPLEX, AND FRAGMENTS OF PREVIOUS STENTS WERE PRESENT WITHIN THE TRACHEA. THEREFORE, THE NOTED DAMAGES TO THE RETURNED DEVICE WERE LIKELY DUE TO ANATOMICAL OR PROCEDURAL FACTORS, WHICH LIMITED THE PERFORMANCE OF THE DEVICE AND CONTRIBUTED TO THE FAILURE LATER ON. CONSEQUENTLY, A REVIEW AND ANALYSIS OF ALL AVAILABLE INFORMATION INDICATES THAT THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT. A LABELING REVIEW WAS PERFORMED, AND FROM THE INFORMATION AVAILABLE THIS DEVICE WAS USED PER THE DIRECTIONS FOR USE (DFU) / PRODUCT LABEL. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) REVEALED NO NON-CONFORMING EVENTS OR DEVIATIONS. A SEARCH OF THE COMPLAINT DATABASE CONFIRMED THAT NO SIMILAR COMPLAINTS EXIST FOR THE SPECIFIED LOT.

Description of Event or Problem

IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2017 THAT A POLYFLEX AIRWAY STENT WAS IMPLANTED THROUGH PREVIOUSLY PLACED NITINOL UNCOVERED STENT TO TRY TO PREVENT FURTHER INGROWTH OF GRANULATION TISSUE IN THE TRACHEA DURING A STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2016. THE PATIENT HAD RECEIVED 2 OR 3 PREVIOUS UNCOVERED NITINOL STENTS OVER THE PAST 15 YEARS TO TREAT AN UNDERLYING CONDITION OF BENIGN FOCAL TRACHEOMALACIA FOLLOWING A THYROIDECTOMY. FOR THE PAST 5 YEARS THE PATIENT HAD BEEN DEVELOPING WORSENING STRIDOR. THE PREVIOUS STENTS HAD COMPLETELY BROKEN DOWN AND GRANULATION TISSUE WAS NEARLY TOTALLY OCCLUDING THE AIRWAY. DEBRIDEMENT OF THE TISSUE WAS PERFORMED 4 TIMES BUT THE TISSUE GRANULATION WOULD RECUR WITHIN WEEKS. REPORTEDLY, FOLLOWING THE IMPLANTATION OF THE POLYFLEX STENT THE PATIENT EXPERIENCED NEAR COMPLETE SYMPTOM CONTROL. ACCORDING TO THE COMPLAINANT, THE PATIENT EXPERIENCED A RAPID ONSET OF BREATHLESSNESS AND STRIDOR ON (B)(6) 2017. AN ELECTIVE BRONCHOSCOPY WAS PERFORMED ON (B)(6) 2017 AND THE PHYSICIAN NOTED THAT THE INNER SILICON LINING OF THE STENT APPEARED TO HAVE SEPARATED FROM THE OUTER MESH AND WAS PARTIALLY OBSTRUCTING THE STENT. THE PHYSICIAN USED A MICRODEBRIDER TO REMOVE THE PROTRUDING MATERIAL, THE LINING WAS BROKEN INTO SMALL PIECES AND SUCTIONED FROM THE PATIENT, AND THE STENT'S LUMEN PATENCY WAS RESTORED. REPORTEDLY, THE STENT IS SCHEDULED TO BE REMOVED ON (B)(6) 2017. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE. ACCORDING TO THE PHYSICIAN, HE WAS NOT SURE IF THE DAMAGE TO THE STENT LINING WAS A DEVICE MALFUNCTION OR WHETHER IT COULD HAVE BEEN DUE TO THE INHALED NEBULIZED N-ACETYLCYSTEIN (400 MG BD) THE PATIENT WAS PRESCRIBED AS PART OF ROUTINE SECRETION MANAGEMENT.