WALLFLEX COLONIC
Report
- Report Number
- 3005099803-2024-06357
- Event Type
- Injury
- Date Received
- December 18, 2024
- Date of Event
- November 4, 2024
- Report Date
- March 14, 2025
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- MQR
- UDI-DI
- 08714729456575
- PMA / PMN Number
- K061877
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SZ
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
BLOCKS G4 (PREMARKET/510(K) AND H11 HAVE BEEN CORRECTED. BLOCK G4: PREMARKET/510(K): K201159; REPORTED HERE AS THIS EXCEEDED CHARACTER LIMIT FOR THE DESIGNATED FIELD. BLOCK H6: IMDRF DEVICE CODE A0401 CAPTURES THE REPORTABLE EVENT OF STENT BREAK. IMDRF DEVICE CODE A0406 CAPTURES THE REPORTABLE EVENT OF STENT MATERIAL DEFORMATION. BLOCK H11: A WALLFLEX ENTERAL STENT WAS RECEIVED FOR ANALYSIS; THE DELIVERY SYSTEM WAS NOT RETURNED. VISUAL INSPECTION WAS PERFORMED, AND THE STENT WAS FOUND UNRAVELED AND DEFORMED. ADDITIONALLY, MEDIA INSPECTION WAS PERFORMED ON A PHOTO PROVIDED BY THE COMPLAINANT, AND IT WAS OBSERVED AGAIN THAT THE STENT WAS UNRAVELED. NO OTHER DAMAGES WERE NOTED ON THE DEVICE. PRODUCT ANALYSIS CONFIRMED THE REPORTED EVENTS OF STENT BREAK AND STENT MATERIAL DEFORMATION. THE INVESTIGATION CONCLUDED THAT THE REPORTED EVENTS WERE MOST LIKELY DUE TO PROCEDURAL FACTORS ENCOUNTERED DURING THE PROCEDURE. IT MAY BE THAT LESION CHARACTERISTICS, HANDLING OF THE DEVICE AND THE TECHNIQUE USED BY THE PHYSICIAN (FORCE APPLIED), LIMITED THE PERFORMANCE OF THE DEVICE AND CONTRIBUTED TO THE REPORTED EVENTS. TAKING ALL AVAILABLE INFORMATION INTO CONSIDERATION, THE MOST PROBABLE CAUSE OF THE REPORTED EVENTS IS ADVERSE EVENT RELATED TO PROCEDURE. A LABELING REVIEW WAS PERFORMED AND, FROM THE INFORMATION AVAILABLE, THERE IS NO INFORMATION THAT THIS DEVICE WAS USED IN A MANNER INCONSISTENT WITH THE INSTRUCTIONS FOR USE (IFU) / PRODUCT LABEL.
BLOCK G4: PREMARKET/510(K): K061877, K201159; REPORTED HERE AS THIS EXCEEDED CHARACTER LIMIT FOR THE DESIGNATED FIELD. BLOCK H6: IMDRF DEVICE CODE A0401 CAPTURES THE REPORTABLE EVENT OF STENT BREAK. IMDRF DEVICE CODE A0406 CAPTURES THE REPORTABLE EVENT OF STENT MATERIAL DEFORMATION.
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX ENTERAL COLONIC STENT WAS TO BE IMPLANTED IN THE COLON TO TREAT A STRICTURE DUE TO CANCER DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2024. THE PATIENT'S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE STENT WAS ATTEMPTED TO BE DEPLOYED; HOWEVER, DURING DEPLOYMENT, THE WIRES OF THE STENT BROKE, AND THE STENT LOST ITS FORM. THE STENT WAS REMOVED USING FORCEPS. THE PROCEDURE WAS COMPLETED USING A DIFFERENT STENT. THERE WAS NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AFTER THE PROCEDURE WAS REPORTED TO BE FINE. A PHOTO OF THE COMPLAINT DEVICE WAS PROVIDED, AND THE STENT WAS NOTED TO BE DEFORMED, AND THE WIRES WERE BROKEN.
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX ENTERAL COLONIC STENT WAS TO BE IMPLANTED IN THE COLON TO TREAT A STRICTURE DUE TO CANCER DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2024. THE PATIENT'S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE STENT WAS ATTEMPTED TO BE DEPLOYED; HOWEVER, DURING DEPLOYMENT, THE WIRES OF THE STENT BROKE, AND THE STENT LOST ITS FORM. THE STENT WAS REMOVED USING FORCEPS. THE PROCEDURE WAS COMPLETED USING A DIFFERENT STENT. THERE WAS NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AFTER THE PROCEDURE WAS REPORTED TO BE FINE. A PHOTO OF THE COMPLAINT DEVICE WAS PROVIDED, AND THE STENT WAS NOTED TO BE DEFORMED, AND THE WIRES WERE BROKEN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2114612 | WALLFLEX COLONIC | STENT, COLONIC, METALIC, EXPANDABLE | MQR | BOSTON SCIENTIFIC CORPORATION | M00565100 | 0034534640 | 08714729456575 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention |