WALLSTENT ENDOPROSTHESIS
Received Dec 22, 2025 · Event occurred Dec 1, 2025
Report 2124215-2025-92286 · MDR key 23864530
Device
Generic name
Catheter, Biliary, Diagnostic
Manufacturer
Boston Scientific CorporationModel number
26280Catalog number
26280
Lot number
0034180955
Product problems
- Activation Failure
- Activation Failure
Patient
75 YR · Male
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
H6: EVALUATION CONCLUSION CODES: UPDATED. (B)(6). GOOD FAITH EFFORT ATTEMPTS WERE MADE TO TRY AND RETRIEVE ADDITIONAL DETAILS REGARDING THE REPORTED EVENT, BUT FURTHER INFORMATION WAS UNABLE TO BE OBTAINED.
Description of Event or Problem
IT WAS REPORTER THAT THE STENT FAILED TO DEPLOY RESULTING IN PROCEDURE CANCELLATION. THE TARGET LESION WAS LOCATED IN THE LOWER EXTREMITY VEINS. A 75CM WALLSTENT UNI WAS SELECTED FOR USE. DURING THE PROCEDURE, THE STENT WAS UNABLE TO BE DEPLOYED PROPERLY DESPITE MULTIPLE ATTEMPTS. THE DEVICE WAS REMOVED COMPLETELY AND INTACT FROM THE PATIENT'S BODY AND THE PROCEDURE WAS CONCLUDED. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. THE PROCEDURE WAS CANCELLED AS A RESULT OF THE DEVICE MALFUNCTION.
Additional Manufacturer Narrative
E1: INITIAL REPORTER PHONE: (B)(6) GOOD FAITH EFFORT ATTEMPTS WERE MADE TO TRY AND RETRIEVE ADDITIONAL DETAILS REGARDING THE REPORTED EVENT, BUT FURTHER INFORMATION WAS UNABLE TO BE OBTAINED.
Description of Event or Problem
IT WAS REPORTER THAT THE STENT FAILED TO DEPLOY RESULTING IN PROCEDURE CANCELLATION. THE TARGET LESION WAS LOCATED IN THE LOWER EXTREMITY VEINS. A 75CM WALLSTENT UNI WAS SELECTED FOR USE. DURING THE PROCEDURE, THE STENT WAS UNABLE TO BE DEPLOYED PROPERLY DESPITE MULTIPLE ATTEMPTS. THE DEVICE WAS REMOVED COMPLETELY AND INTACT FROM THE PATIENT'S BODY AND THE PROCEDURE WAS CONCLUDED. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. THE PROCEDURE WAS CANCELLED AS A RESULT OF THE DEVICE MALFUNCTION.