WALLFLEX? DUODENAL

Additional Manufacturer Narrative

BLOCK E1: INITIAL REPORTER FACILITY NAME: (B)(6); REPORTED HERE AS IT EXCEEDED THE CHARACTER LIMIT FOR THE DESIGNATED FIELD. BLOCK H6: IMDRF DEVICE CODE A0406 CAPTURES THE REPORTABLE EVENT OF STENT MATERIAL DEFORMATION.

Description of Event or Problem

IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX ENTERAL STENT WAS TO BE IMPLANTED TO TREAT A DUODENAL OBSTRUCTION IN THE DUODENUM DURING AN INTESTINAL STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, BURRS WERE IDENTIFIED AT THE DISTAL END OF THE STENT, AND THE SURFACE OF THE STENT WAS NOT SMOOTH. ANOTHER WALLFLEX ENTERAL STENT WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. THE PATIENT CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

Additional Manufacturer Narrative

BLOCK B5 AND H6 (DEVICE CODE) HAS BEEN UPDATED WITH THE INFORMATION RECEIVED ON MAY 12, 2026. BLOCK E1: INITIAL REPORTER FACILITY NAME: (B)(6); REPORTED HERE AS IT EXCEEDED THE CHARACTER LIMIT FOR THE DESIGNATED FIELD. BLOCK H6: IMDRF DEVICE CODE A0406 CAPTURES THE REPORTABLE EVENT OF STENT MATERIAL DEFORMATION. BLOCK H11: INVESTIGATION RESULTS: BOSTON SCIENTIFIC CORPORATION COULD NOT CONFIRM THE REPORTED EVENT OF STENT MATERIAL DEFORMATION AND STENT PARTIALLY DEPLOYED. THE DEVICE WAS NOT RETURNED; THEREFORE, PRODUCT ANALYSIS COULD NOT BE PERFORMED. WITHOUT PROPER EVALUATION OF THE DEVICE, IT IS UNKNOWN IF THE REPORTED EVENTS WERE DUE TO THE TECHNIQUE USED DURING THE PROCEDURE, ANATOMICAL CONDITIONS OR RELATED TO DEVICE MALFUNCTION. DEVICE HISTORY RECORD REVIEW: IT WAS CONFIRMED THIS DEVICE MET MANUFACTURING SPECIFICATION PRIOR TO DISTRIBUTION AND THERE WERE NO MANUFACTURING DEVIATIONS WHICH HAVE CONTRIBUTED TO THE REPORTED EVENT DEVICE TECHNICAL ANALYSIS: THE DEVICE WAS NOT RETURNED; THEREFORE, PRODUCT ANALYSIS COULD NOT BE PERFORMED. RISK REVIEW: A RISK REVIEW WAS COMPLETED AND CONFIRMED THAT THE EVENT OF "STENT MATERIAL DEFORMATION" WAS DEFINED IN THE RISK DOCUMENTATION. THIS EVENT TYPE HAS BEEN ACCOUNTED FOR DURING PRODUCT RISK ANALYSIS TO SUPPORT ACCEPTABLE RISK BENEFIT FOR THE PRODUCT. INVESTIGATION CONCLUSION: BASED ON A THOROUGH REVIEW OF THE REPORTED COMPLAINT, BOSTON SCIENTIFIC HAS ASSIGNED AN INVESTIGATION CONCLUSION CODE OF CAUSE NOT ESTABLISHED.

Description of Event or Problem

IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX ENTERAL STENT WAS TO BE IMPLANTED TO TREAT A DUODENAL OBSTRUCTION IN THE DUODENUM DURING AN ENDOSCOPIC INTESTINAL STENT IMPLANTATION PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, BURRS WERE IDENTIFIED AT THE DISTAL END OF THE STENT, AND THE SURFACE OF THE STENT WAS NOT SMOOTH. ALSO, ADDITIONAL INFORMATION RECEIVED CONFIRMED THAT THE STENT WAS REMOVED IN A PARTIALLY DEPLOYED STATE TOGETHER WITH THE DELIVERY SYSTEM. ANOTHER WALLFLEX ENTERAL STENT WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. THE PATIENT CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.