inforMED
MalfunctionMAF

WALLSTENT ENDOPROSTHESIS

Received Dec 22, 2025 · Event occurred Sep 22, 2025

Report 2124215-2025-92381 · MDR key 23868078

Device

Generic name

Catheter, Biliary, Diagnostic

Model number

H965403330

Catalog number

H965403330

Lot number

0034586099

Product problems

  • Adverse Event Without Identified Device or Use Problem
  • Activation Failure
  • Adverse Event Without Identified Device or Use Problem
  • Activation Failure

Patient

68 YR · Female

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

Narrative

Additional Manufacturer Narrative

E1 - INITIAL REPORTER PHONE: (B)(6). G4 - PREMARKET / 510(K) #: K152842, K980163, P980033. DEVICE EVALUATED BY MFR: THE WALLSTENT UNI WAS RETURNED FOR ANALYSIS. THE DEVICE WAS RETURNED WITH THE STENT ALREADY DEPLOYED FROM THE DELIVERY SYSTEM. THE DEPLOYED STENT WAS NOT RETURNED WITH THE DEVICE. A VISUAL EXAMINATION IDENTIFIED NO DAMAGE TO THE STENT HOLDER. THE STENT CUP WAS NOTED TO BE DAMAGED. A VISUAL AND TACTILE EXAMINATION IDENTIFIED NO ISSUES WITH THE TIP OF THE DEVICE. A VISUAL AND TACTILE EXAMINATION OF THE SHAFT IDENTIFIED NO ISSUES. NO OTHER ISSUES WERE IDENTIFIED WITH THE DEVICE.

Description of Event or Problem

REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 02DEC2025. IT WAS REPORTED THAT THE STENT FAILED TO DEPLOY. THE STENOSED TARGET LESION WAS LOCATED IN THE ILIAC VEIN. A 75CM WALLSTENT-UNI ENDOPROSTHESIS SELF-EXPANDING WAS SELECTED FOR USE. DURING THE PROCEDURE, THE STENT COULD NOT BE DEPLOYED NORMALLY. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. HOWEVER, DEVICE ANALYSIS REVEALED THAT THE STENT ALREADY DEPLOYED FROM THE DELIVERY SYSTEM AND THE STENT CUP WAS NOTED TO BE DAMAGED.