WALLSTENT ENDOPROSTHESIS
Received Feb 13, 2026 · Event occurred Jan 19, 2026
Report 2124215-2026-08339 · MDR key 24337580
Device
Generic name
Catheter, Biliary, Diagnostic
Manufacturer
Boston Scientific CorporationModel number
26280Catalog number
26280
Lot number
0033370534
Product problems
- Deformation Due to Compressive Stress
- Adverse Event Without Identified Device or Use Problem
Patient
68 YR · Male
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
E1: INITIAL REPORTER PHONE: (B)(6). INVESTIGATION RESULTS: DEVICE EVALUATED BY MFR: THE 75CM WALLSTENT UNI DEVICE WAS RETURNED TO OUR POST MARKET QUALITY ASSURANCE LABORATORY. A VISUAL EXAMINATION FOUND THE STENT OF THE DEVICE TO BE PARTIALLY DEPLOYED ON THE DELIVERY SYSTEM. NO DAMAGE WAS NOTED TO THE STENT. A VISUAL AND TACTILE INSPECTION FOUND THE SHEATH OF THE DEVICE TO BE KINKED AT MORE THAN ONE LOCATION. NO OTHER ISSUES WERE NOTED WITH THE DELIVERY SYSTEM. A VISUAL EXAMINATION IDENTIFIED NO ISSUES WITH THE TIP OF THE DEVICE. DEVICE HISTORY RECORD: IT WAS CONFIRMED THIS DEVICE MET MANUFACTURING SPECIFICATION PRIOR TO DISTRIBUTION AND THERE WERE NO MANUFACTURING DEVIATIONS WHICH COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. LABELING REVIEW: REVIEW OF THE INSTRUCTIONS FOR USE (IFU) CONFIRMED THAT THE CONTENT WAS SUFFICIENT AND DID NOT CONTRIBUTE TO THE REPORTED EVENT; THEREFORE, NO UPDATES ARE REQUIRED TO THE DOCUMENT AT THIS TIME. RISK REVIEW: A RISK REVIEW PERFORMED FOR THE 75CM WALLSTENT UNI DEVICE CONFIRMED THAT THE REPORTED EVENT IS A KNOWN EVENT DEFINED IN THE PRODUCT'S RISK MANAGEMENT DOCUMENTATION. THIS EVENT TYPE HAS BEEN ACCOUNTED FOR DURING PRODUCT RISK ANALYSIS TO SUPPORT ACCEPTABLE RISK BENEFITS FOR THE PRODUCT. INVESTIGATION CONCLUSION: BASED ON A THOROUGH REVIEW OF THE REPORTED COMPLAINT, BOSTON SCIENTIFIC HAS ASSIGNED AN INVESTIGATION CONCLUSION CODE OF NO PROBLEM DETECTED.
Description of Event or Problem
IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE SEVERELY STENOSED TARGET LESION WAS LOCATED IN THE COMMON ILIAC VEIN. A 75CM WALLSTENT UNI WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE TIP OF THE STENT WAS DAMAGED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.
Additional Manufacturer Narrative
E1: INITIAL REPORTER PHONE: (B)(6).
Description of Event or Problem
IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE SEVERELY STENOSED TARGET LESION WAS LOCATED IN THE COMMON ILIAC VEIN. A 75CM WALLSTENT UNI WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE TIP OF THE STENT WAS DAMAGED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.