inforMED
MalfunctionMAF

WALLSTENT ENDOPROSTHESIS

Received Apr 2, 2025 · Event occurred Jan 11, 2025

Report 2124215-2025-18393 · MDR key 21753526

Device

Generic name

Catheter, Biliary, Diagnostic

Model number

26280

Catalog number

26280

Lot number

0033260645

Product problems

  • Failure to Advance
  • Adverse Event Without Identified Device or Use Problem
  • Failure to Advance
  • Adverse Event Without Identified Device or Use Problem

Patient

72 YR · Female

  • No Clinical Signs, Symptoms or Conditions
  • No Clinical Signs, Symptoms or Conditions

Narrative

Additional Manufacturer Narrative

DEVICE EVAL BY MANUFACTURER: THIS WALLSTENT ENDOPROSTHESIS WAS RECEIVED FOR ANALYSIS. VISUAL EXAMINATION IDENTIFIED THAT THE STENT WAS PARTIALLY DEPLOYED AND DAMAGED. FURTHER VISUAL AND TACTILE EXAMINATION IDENTIFIED NO ISSUES WITH THE TIP OR SHAFT OF THE DEVICE.

Description of Event or Problem

REPORTABLE UPON ANALYSIS COMPLETED ON (B)(6)2025. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED ILIAC ARTERY. A 14X90/9 WALLSTENT ENDOPROSTHESIS WAS SELECTED FOR USE. DURING THE PROCEDURE, THE DEVICE WAS INSERTED INTO THE PATIENT; HOWEVER, THE PRODUCT WAS UNABLE TO TRAVERSE THE LESION. AS A RESULT, THE PHYSICIAN SUBSEQUENTLY WITHDREW THE PRODUCT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE WITH A DIFFERENT LOT NUMBER. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.