inforMED
MalfunctionMAF

WALLSTENT ENDOPROSTHESIS

Received Sep 9, 2024 · Event occurred Jun 26, 2024

Report 2124215-2024-54782 · MDR key 20168946

Device

Generic name

Catheter, Biliary, Diagnostic

Model number

26280

Catalog number

26280

Lot number

0029702577

Product problems

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

Patient

56 YR · Female

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

Narrative

Description of Event or Problem

REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 14AUG2024. IT WAS REPORTED THAT DEPLOYMENT FAILURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE ILIAC VEIN. A 16X90/9FR 75CM WALLSTENT ENDOPROSTHESIS SELF-EXPANDING STENT WAS SELECTED FOR USE. DURING THE PROCEDURE, THE DELIVERY SHAFT COULD NOT BE ADVANCED, AND THE STENT COULD NOT BE DEPLOYED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS STABLE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED A DAMAGE TO THE DISTAL STENT WIRES.

Additional Manufacturer Narrative

DEVICE EVALUATED BY MFR.: THE DEVICE WAS RECEIVED WITH THE STENT FULLY CONSTRAINED IN THE CORRECT POSITION ON THE DEVICE. THE STENT WAS SUCCESSFULLY DEPLOYED WITHOUT ISSUE. A VISUAL EXAMINATION IDENTIFIED DAMAGE TO THE DISTAL STENT WIRES CAUSED BY SEVERE KINKING TO THE OUTER AND INNER SHEATH OF THE DEVICE. A VISUAL AND TACTILE EXAMINATION FOUND BOTH THE INNER AND OUTER SHEATH TO BE SEVERELY KINKED AT MORE THAN ONE LOCATION. THE KINKING WAS NOTED TO HAVE CONTRIBUTED TO STENT DAMAGE. A VISUAL AND TACTILE EXAMINATION IDENTIFIED NO DAMAGE OR ISSUES WITH THE TIP OF THE DEVICE.