WALLFLEX BILIARY

Description of Event or Problem

IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX BILIARY STENT WAS IMPLANTED DURING A PROCEDURE PERFORMED ON AN UNKNOWN DATE. APPROXIMATELY THREE MONTHS POST-PROCEDURE, ON (B)(6) 2026, AN ATTEMPT WAS MADE TO REMOVE THE STENT FROM THE DUCT; HOWEVER, INITIAL REMOVAL WAS UNSUCCESSFUL. DURING SUBSEQUENT REMOVAL ATTEMPTS, THE DISTAL WIRES OF THE STENT WERE OBSERVED TO HAVE BECOME MANGLED. FOLLOWING MULTIPLE ATTEMPTS, THE PHYSICIAN WAS ULTIMATELY ABLE TO REMOVE THE STENT USING RAT-TOOTH FORCEPS. AS A RESULT, THE PROCEDURE WAS PROLONGED. IT WAS UNKNOWN IF THERE WERE PATIENT COMPLICATIONS AS A RESULT OF THE PROCEDURE. NOTE: BASED ON THE PHOTO PROVIDED IT WAS OBSERVED THAT THE STENT WAS BROKEN AND DEFORMED.

Additional Manufacturer Narrative

BLOCK D4, H4: THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER. BECAUSE THE PRODUCT IS UNKNOWN AT THIS TIME, WE ARE UNABLE TO PROVIDE THE COMPLETE UNIQUE IDENTIFIER (UDI) # AND OTHER PRODUCT SPECIFIC INFORMATION. WE'VE SENT GOOD FAITH EFFORT ATTEMPTS TO OBTAIN ALL MISSING INFORMATION. IF ADDITIONAL DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. BLOCK H6: IMDRF DEVICE CODE A0406 CAPTURES THE REPORTABLE EVENT OF STENT MATERIAL DEFORMATION. IMDRF DEVICE CODE A150207 CAPTURES THE REPORTABLE EVENT OF STENT DIFFICULT TO REMOVE. IMDRF DEVICE CODE A0401 CAPTURES THE REPORTABLE EVENT OF STENT BREAK.