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Zilver Vena G57434Recalls & reported problems

Cook Ireland Ltd · Zilver Vena, Venous Self-Expanding Stent · Class 3 · Implant

All models of Zilver Vena (19)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
3
Deaths reported
0
Injuries reported
2
Recalls naming it
0

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10827002574349), received between Aug 2, 2023 and Aug 8, 2023 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (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

Device problems

  • Improper or Incorrect Procedure or Method2
  • Migration2
  • Use of Device Problem1

Patient problems

  • No Clinical Signs, Symptoms or Conditions3
  • Dyspnea1

Recent adverse event reports

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

  • MalfunctionAug 8, 2023Use of Device Problem; Improper or Incorrect Procedure or Method; Use of Device Problem; Improper or Incorrect Procedure or Method

    SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION ON 18-DEC-2023.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17480617 ↗
  • InjuryAug 3, 2023Improper or Incorrect Procedure or Method; Migration; Improper or Incorrect Procedure or Method; Migration

    RT COMMON AND EXTERNAL ILIAC VEIN WAS STENTED WITH ZILVER VENA FOR ILIAC VEIN COMPRESSION. CASE WAS SUCCESSFUL, NO PROBLEMS. PT RETURNED TO HAVE LLE VENOGRAM, NOTICED RLE STENTS HAD TRAVELED TO PULMONARY ARTERY/RT ATRIUM. THE FOLLOWING INFORMATION HAS BEEN RECEIVED VIA EMAIL ON 05JUL2023. 1. DID ANY UNINTENDED SECTION OF THE DEVICE REMAIN INSIDE THE PATIENT¿S BODY? YES. NOT YET RETRIEVED-REFERRING TO CT SURGERY TODAY ((B)(6) 2023). 2. WAS THE PATIENT HOSPITALIZED OR WAS THERE PROLONGED HOSPITALIZATION? YES. 3. DID THE PATIENT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE? YES. 4. DID THE PRODUCT CAUSE OR CONTRIBUTE TO THE NEED FOR ADDITIONAL PROCEDURES? YES. A. IF YES, PLEASE SPECIFY ADDITIONAL PROCEDURES AND PROVIDE DETAILS. CT SURGERY TO PERFORM STENT REMOVAL. 5. HAS THE COMPLAINANT REPORTED ANY ADVERSE EFFECTS ON THE PATIENT DUE TO THIS OCCURRENCE? YES. 6. HAS THE COMPLAINANT REPORTED THAT THE PRODUCT CAUSED OR CONTRIBUTED TO THE ADVERSE EFFECTS? YES. A. PLEASE SPECIFY ADVERSE EFFECTS AND PROVIDE DETAILS. IN RETROSPECT, PT WAS SHORT OF BREATH. THE FOLLOWING INFORMATION HAS BEEN RECEIVED VIA EMAIL ON (B)(6). CASE WAS SUCCESSFUL, NO PROBLEMS. 3.92 DID THE PATIENT HAVE P

    Patient problems: Dyspnea; No Clinical Signs, Symptoms or Conditions

    MAUDE report 17450771 ↗
  • InjuryAug 2, 2023Migration; Migration

    RT COMMON AND EXTERNAL ILIAC VEIN WAS STENTED WITH ZILVER VENA FOR ILIAC VEIN COMPRESSION. CASE WAS SUCCESSFUL, NO PROBLEMS. PT RETURNED TO HAVE LLE VENOGRAM, NOTICED RLE STENTS HAD TRAVELED TO PULMONARY ARTERY/RT ATRIUM.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17441650 ↗

Other Stent, iliac vein devices

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Sources and updates

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