WALLFLEX? COLONIC

Additional Manufacturer Narrative

BLOCK B3: DATE OF EVENT: DATE OF EVENT WAS APPROXIMATED TO MAY 01, 2026, AS NO EVENT DATE WAS REPORTED. BLOCK D4, H4: THE COMPLAINANT WAS UNABLE TO PROVIDE THE COMPLAINT DEVICE UPN AND 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. IF ADDITIONAL DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. BLOCK H11: IMDRF DEVICE CODE A1502 CAPTURES THE REPORTABLE EVENT OF STENT POSITIONING PROBLEM. IMDRF IMPACT CODE F2202 CAPTURES THE ENDOSCOPIC PROCEDURE FOR STENT REMOVAL. IMDRF IMPACT CODE F2301 CAPTURES THE REPORTABLE EVENT OF ADDITIONAL DEVICE REQUIRED TO REMOVE THE STENT.

Description of Event or Problem

IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX ENTERAL STENT WAS USED TO TREAT A RECTAL STRICTURE LOCATED NEAR THE ANUS DURING A COLONIC STENT PROCEDURE PERFORMED ON AN UNKNOWN DATE. IT WAS REPORTED THAT THE PATIENT HAD A COLONIC STENT PLACED AT A DIFFERENT HOSPITAL AND CAME TO USC TO HAVE THE STENT REMOVED. THE STENT HAD BEEN POSITIONED TOO CLOSE TO THE ANUS, RESULTING IN PATIENT DISCOMFORT. THE STENT WAS SUCCESSFULLY REMOVED BY THE PHYSICIAN, WHO EXTRACTED IT THROUGH A SURGICAL TUBE.