WALLSTENT® Endoprosthesis H965405110Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08714729204169), received between Aug 5, 2019 and Jun 7, 2022 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (2 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 18, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJun 7, 2022Material Deformation; Migration; Material Deformation; Migration

  IT WAS REPORTED THAT THE STENT MIGRATED AND WAS DEFORMED. ON (B)(6) 2018 A 24MM X 4.5CM WALLSTENT WAS DEPLOYED; HOWEVER, DURING DILATION, THE STENT MIGRATED CAUDALLY ON THE GUIDEWIRE INTO THE RIGHT ATRIUM. LEFT COMMON FEMORAL AND A SECOND RIGHT COMMON FEMORAL VENOUS ACCESS WAS OBTAINED. THE MIGRATED STENT WAS MANIPULATED USING MULTIPLE TECHNIQUES INCLUDING: MANIPULATION WITH A BALLOON, SNARE CAPTURE, AND USE OF ENDOBRONCHIAL FORCEPS. THE STENT WAS ULTIMATELY MANIPULATED INTO THE INFRARENAL INFERIOR VENA CAVA AND SUBSEQUENT VENOGRAPHY DEMONSTRATED HIGH VELOCITY ANTEGRADE FLOW WITHOUT THROMBUS OR OCCLUSION. WHILE REPOSITIONING THE STENT WITH FORCEPS, A CORNER OF THE STENT WAS MANIPULATED BENDING SOME WIRES AT THE CAUDAL END OF THE STENT. POSTOPERATIVELY, ON JUNE 8, 2018, THE PATIENT REPORTED SHORTNESS OF BREATH AND WAS PRESCRIBED CROMOLYN. "OOZING" WAS ALSO NOTED AT THE GROIN PUNCTURE SITE AFTER THE CASE, FOR WHICH DRESSINGS WERE FREQUENTLY CHANGED AND PRESSURE WAS APPLIED WITH A SANDBAG.

  Patient problems: Dyspnea

  MAUDE report 14622393 ↗
• MalfunctionJan 21, 2020Positioning Failure; Positioning Failure

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 06JAN2020. IT WAS REPORTED THAT STENT DEPLOYMENT FAILURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE INFERIOR VENA CAVA VEIN. A 24X45/11FR UNI PLUS 75CM WALLSTENT ENDOPROSTHESIS WAS ADVANCED FOR TREATMENT. HOWEVER, THE DISTAL END OF THE STENT WOULD NOT OPEN UP WHEN TRIED TO DEPLOY. SUBSEQUENTLY, THE PHYSICIAN RECONSTRAINED THE STENT AND TRIED TO DEPLOY IT AGAIN BUT WAS UNSUCCESSFUL. THE DEVICE WAS THEN REMOVED IN A FULLY RECONSTRAINED STATE AND ANOTHER 22X45 WALLSTENT WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED STENT DAMAGE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9612216 ↗
• MalfunctionAug 5, 2019Material Deformation; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN THE SUPERIOR VENA CAVA VEIN THAT WAS COMPLETELY CLOSED BY TUMOR COMPRESSION. AFTER PRE-DILATION, A 24X45/11FR UNI PLUS 75CM WALLSTENT ENDOPROSTHESIS SELF EXPANDING STENT WAS SELECTED FOR USE AND WAS PRE-DEPLOYED IN VITRO. HOWEVER, IT WAS NOTED THAT THE TIP OF THE STENT STRUTS WERE LIFTED UP. THE DEVICE WAS REPLACED WITH ANOTHER OF THE SAME DEVICE AND THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED AND PATIENT IS STABLE.

  Patient problems: No Patient Involvement

  MAUDE report 8861335 ↗