WALLSTENT ENDOPROSTHESIS
Received Nov 13, 2025 · Event occurred Oct 13, 2025
Report 2124215-2025-81168 · MDR key 23548017
Device
Generic name
Catheter, Biliary, Diagnostic
Manufacturer
Boston Scientific CorporationModel number
26280Catalog number
26280
Lot number
0034558278
Product problems
- Deformation Due to Compressive Stress
- Adverse Event Without Identified Device or Use Problem
- Deformation Due to Compressive Stress
- Adverse Event Without Identified Device or Use Problem
Patient
50 YR · Male
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE PATIENT HAD PULMONARY MALIGNANCY AND SUPERIOR VENA CAVA COMPRESSION. A 12MM X 90MM WALLSTENT ENDOPROSTHESIS STENT SELF EXPANDING WAS SELECTED FOR USE IN THE SUPERIOR VENA CAVA. DURING THE PROCEDURE, DIGITAL SUBTRACTION ANGIOGRAPHY (DSA) SHOWED THAT THE STENT HAD KINK MARKS, WHICH WERE CONFIRMED AFTER THE STENT WAS REMOVED FROM THE BODY. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT, AND THE PATIENT WAS IN STABLE CONDITION FOLLOWING THE PROCEDURE.
Additional Manufacturer Narrative
E1: INITIAL REPORTER FACILITY NAME: (B)(6). E1, INITIAL REPORTER PHONE NUMBER: (B)(6). DEVICE EVAL BY MANUFACTURER: THE DEVICE WAS RETURNED FOR EVALUATION. IT WAS RECEIVED SHEATHED, WITH THE STENT FULLY DEPLOYED FROM THE DELIVERY SYSTEM. THE STENT WAS OBSERVED TO BE DAMAGED. VISUAL AND TACTILE INSPECTION REVEALED NO ABNORMALITIES AT THE DISTAL TIP OF THE DEVICE. HOWEVER, AN OUTER SHEATH KINK WAS IDENTIFIED APPROXIMATELY 85 MM PROXIMAL TO THE DISTAL TIP.
Additional Manufacturer Narrative
E1: INITIAL REPORTER FACILITY NAME:(B)(6).
Description of Event or Problem
IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE PATIENT HAD PULMONARY MALIGNANCY AND SUPERIOR VENA CAVA COMPRESSION. A 12MM X 90MM WALLSTENT ENDOPROSTHESIS STENT SELF EXPANDING WAS SELECTED FOR USE IN THE SUPERIOR VENA CAVA. DURING THE PROCEDURE, DIGITAL SUBTRACTION ANGIOGRAPHY (DSA) SHOWED THAT THE STENT HAD KINK MARKS, WHICH WERE CONFIRMED AFTER THE STENT WAS REMOVED FROM THE BODY. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT, AND THE PATIENT WAS IN STABLE CONDITION FOLLOWING THE PROCEDURE.