WALLSTENT® Endoprosthesis H965403310Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08714729204039), received between Dec 5, 2019 and Dec 15, 2022 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Material Deformation” (3 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 15, 2022Difficult to Advance; Material Deformation; Difficult to Advance; Material Deformation

  IT WAS REPORTED THAT THE PROCEDURE WAS ABORTED. THE PATIENT PRESENTED FOR VENOUS STENT IMPLANTATION. THE TARGET LESION WAS LOCATED IN THE SEVERELY STENOSED AND OCCLUDED RIGHT ILIAC VEIN. AFTER CROSSING THE GUIDEWIRE INTO THE LESION, PRE-DILATATION WAS PERFORMED. A 16X40/9FR UNI PLUS 75CM WALLSTENT ENDOPROSTHESIS STENT WAS ADVANCED FOR TREATMENT. HOWEVER, DURING DEPLOYMENT, THE DELIVERY SHAFT WAS KINKED AND THE STENT COULD NOT BE IMPLANTED. THE DEVICE WAS WITHDRAWN AND THE PROCEDURE WAS NOT COMPLETED DUE TO AN UNSPECIFIED REASON. IT WAS FURTHER REPORTED THAT TARGET LESION WAS 95% STENOSED, SEVERELY TORTUOUS, AND SEVERELY CALCIFIED. THERE WAS A LARGE RESISTANCE MET DURING DELIVERY OF THE DEVICE. THE PROCEDURE WAS CANCELLED SINCE THE LESION DID NOT OPEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15991290 ↗
• InjuryAug 4, 2020Material Deformation; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE 92% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND NON-CALCIFIED SUBCLAVIAN VEIN. A 16X40/9FR UNI PLUS 75CM WALLSTENT ENDOPROSTHESIS WAS ADVANCED FOR TREATMENT. HOWEVER, THE DEVICE WAS STUCK WITH THE CATHETER. THE PHYSICIAN DEPLOYED THE DEVICE BUT THE STENT WAS FOUND SLIGHTLY TORTUOUS. ANOTHER WALLSTENT WAS DEPLOYED TO COVER THE LESION. THE PROCEDURE WAS COMPLETED WITH NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S STATUS WAS STABLE.

  Patient problems: No Code Available

  MAUDE report 10363221 ↗
• InjuryJun 30, 2020Difficult or Delayed Activation; Material Deformation; Difficult or Delayed Activation; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. A 16X40/9FR UNI PLUS 75CM WALLSTENT ENDOPROSTHESIS WAS SELECTED FOR USE. HOWEVER, RESISTANCE WAS OBSERVED DURING DEPLOYMENT AND THE WEAVE WAS DAMAGED AFTER IMPLANTATION. SUBSEQUENTLY, ANOTHER WALLSTENT WAS USED TO OVERLAP THE FIRST DEPLOYED STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED. THE PROCEDURE WAS COMPLETED AND THE PATIENT STATUS WAS STABLE. IT WAS FURTHER REPORTED THAT THE TARGET LESION HAD 94% STENOSIS WHICH WAS LOCATED IN A MODERATELY TORTUOUS AND NON-CALCIFIED VESSEL. THE STENT STRUTS WERE DAMAGED POST-IMPLANTATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10212168 ↗
• InjuryDec 5, 2019Migration; Migration

  IT WAS REPORTED THAT STENT MIGRATION OCCURRED. THE TARGET LESION WAS LOCATED IN THE RENAL VEIN. AFTER CROSSING A GUIDE WIRE INTO THE RENAL VEIN DOWN TO THE OVARIAN VEIN, A 16X40/9FR WALLSTENT ENDOPROSTHESIS STENT WAS ADVANCED TO TREAT THE LESION. THE STENT WAS 4CM LONG AND THE DISTANCE BETWEEN THE OVARIAN VEIN (OV) AND THE INFERIOR VENA CAVA (IVC) WAS APPROXIMATELY 4CM. THE STENT WAS SUCCESSFULLY DEPLOYED WITH ONE END NEAR THE OSTIUM OF THE OV AND THE OTHER END JUST INSIDE THE IVC. HOWEVER, UPON REMOVING THE DELIVERY SYSTEM, THE STENT MIGRATED BACK INTO THE IVC. IT WAS UNCLEAR IF THE STENT CAUGHT UP WITH THE DELIVERY SYSTEM DURING REMOVAL RESULTING IN MIGRATION OR IF THE STENT JUMPED BACK DURING DEPLOYMENT SINCE THE STENOSIS APPEARED TO BE RIGHT UP AGAINST THE OV WHICH WAS AT THE DISTAL PART OF THE STENT. THE STENT WAS THEN PARTIALLY SNARED AND WAS PULLED BACK INTO THE FEMORAL VEIN. A SMALL CUTDOWN WAS PERFORMED TO REMOVE THE STENT FROM THE PATIENT'S FEMORAL VEIN. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9418290 ↗