MalfunctionMAF
WALLSTENT ENDOPROSTHESIS
Received Mar 5, 2026 · Event occurred Feb 5, 2026
Report 2124215-2026-12349 · MDR key 24521880
Device
Generic name
Catheter, Biliary, Diagnostic
Manufacturer
Boston Scientific CorporationModel number
26280Catalog number
26280
Lot number
0034691243
Product problems
- Break
Patient
58 YR · Male
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
(B)(6).
Description of Event or Problem
IT WAS REPORTED THAT STENT FRACTURE OCCURRED. A SELF-EXPANDING 75CM WALLSTENT ENDOPROSTHESIS WAS CHOSEN FOR VENOUS RECANALIZATION AND STENT PLACEMENT IN THE LOWER EXTREMITY. WHEN THE PACKAGE WAS OPENED, THE CATHETER OUTSIDE THE STENT WAS FOUND TO BE BROKEN, WITH A ROUGH SURFACE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING ANOTHER DEVICE OF THE SAME TYPE. NO PATIENT COMPLICATIONS OCCURRED AS A RESULT OF THIS EVENT.