Zilver Vena G57455Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10827002574554), received between Sep 7, 2021 and May 16, 2024 — classified as 3 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Migration” (4 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 16, 2024Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  ALREADY HAD A STENT ON THE OTHER SIDE THAT WAS PLACED BY A DIFFERENT PHYSICIAN AT A DIFFERENT LAB (MEDTRONIC ABRE STENT). PATIENT OUTCOME: THE FOLLOWING INFORMATION HAS BEEN RECEIVED VIA EMAIL ON 19JUN2023. SG 19JUN2023. 1. DID ANY UNINTENDED SECTION OF THE DEVICE REMAIN INSIDE THE PATIENT¿S BODY? NO. 2. WAS THE PATIENT HOSPITALIZED OR WAS THERE PROLONGED HOSPITALIZATION? NO. 3. DID THE PATIENT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE? AN ADDITIONAL STENT WAS USED INSIDE THE ELONGATED STENT. 4. DID THE PRODUCT CAUSE OR CONTRIBUTE TO THE NEED FOR ADDITIONAL PROCEDURES? NO. 5. HAS THE COMPLAINANT REPORTED ANY ADVERSE EFFECTS ON THE PATIENT DUE TO THIS OCCURRENCE? NO. 6. HAS THE COMPLAINANT REPORTED THAT THE PRODUCT CAUSED OR CONTRIBUTED TO THE ADVERSE EFFECTS? NO. PATIENT/EVENT INFO - NOTES: THE FOLLOWING INFORMATION HAS BEEN REQUESTED VIA EMAIL ON 15JUN2023 / 19JUN2023. SG 19JUN2023. 3.91 ARE IMAGES OF THE DEVICE OR PROCEDURE AVAILABLE? N/A, YES, NO. 3.92 DID THE PATIENT HAVE PRE-EXISTING CONDITIONS? N/A, YES, NO. IF YES, PLEASE SPECIFY: 3.93 PLEASE DESCRIBE THE NATIVE STATE OF THE VESSEL (I.E. WAS THE ANATOMY TORTUOUS? WAS THE VESSEL FIBROTIC?) N/A, TORTUOUS, CALCIF

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19329172 ↗
• MalfunctionJul 13, 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 15-JAN-2024.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17314434 ↗
• MalfunctionJun 12, 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 29-AUG-2023.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17105166 ↗
• InjuryMay 11, 2023Migration; Migration

  SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION ON THE 03-AUG-2023.

  Patient problems: Pancreatitis

  MAUDE report 16909794 ↗
• InjuryMay 2, 2023Migration; Migration

  ACCORDING TO THE INITIAL REPORTER, A 16X140 ZILVER VENA STENT WAS PLACED IN THE ILIAC VEIN IN (B)(6) 2022. THE PATIENT RETURNED FOR A DUPLEX ULTRASOUND IN (B)(6) 2023 AND THE STENT WAS SEEN IN THE ILIAC VEIN. ON (B)(6) 2023, THE PATIENT WENT TO THE EMERGENCY ROOM FOR PANCREATITIS. THE PATIENT WAS GIVEN A CT SCAN FOR HIS PANCREATITIS. IT WAS INCIDENTALLY DISCOVERED THAT THE ZILVER STENT WAS NO LONGER IN THE ILIAC VEIN AND HAD MIGRATED TO THE RIGHT VENTRICLE.

  Patient problems: Pancreatitis

  MAUDE report 16854320 ↗
• MalfunctionApr 12, 2022Migration; Migration

  PER REP - ON (B)(6) 2022 - THE DOCTOR SAID THAT, WHEN HE LANDED THE STENT, IT MOVED UP A LITTLE BIT INTO THE IVC. HE DID NOT LIKE THEY WAY IT DEPLOYED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THE DEVICE IN QUESTION. DID ANY UNINTENDED SECTION OF THE DEVICE REMAIN INSIDE THE PATIENT¿S BODY? NO. IF YES, PLEASE DESCRIBE. WAS THE PATIENT HOSPITALIZED OR WAS THERE PROLONGED HOSPITALIZATION DUE TO THIS OCCURRENCE? NO. DID THE PATIENT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE? NO. IF YES, PLEASE DESCRIBE. DID THE PRODUCT CAUSE OR CONTRIBUTE TO THE NEED FOR ADDITIONAL PROCEDURES? NO IF YES, PLEASE SPECIFY ADDITIONAL PROCEDURES AND PROVIDE DETAILS. HAS THE COMPLAINANT REPORTED ANY ADVERSE EFFECTS ON THE PATIENT DUE TO THIS OCCURRENCE? NO. HAS THE COMPLAINANT REPORTED THAT THE PRODUCT CAUSED OR CONTRIBUTED TO THE ADVERSE EFFECTS? NO. PLEASE SPECIFY ADVERSE EFFECTS AND PROVIDE DETAILS. PREFIX ZVT7. ARE IMAGES OF THE DEVICE OR PROCEDURE AVAILABLE? N/A, YES, NO -NO. DID THE PATIENT HAVE PRE-EXISTING CONDITIONS? N/A, YES, NO -UNKR IF YES, PLEASE SPECIFY. PLEASE DESCRIBE THE NATIVE STATE OF THE VESSEL (I.E. WAS THE ANATOMY TORTUOUS? WAS THE VESSEL FIBROTIC?) N/A, TORTUOUS, CA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14081848 ↗
• InjurySep 7, 2021Migration; Migration

  SUPPLEMENTAL FOLLOW-UP REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION AND AN UPDATE TO THE INVESTIGATION CONCLUSIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12433409 ↗