Zilver Vena G57453Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10827002574530), received between Dec 30, 2020 and Jun 1, 2023 — classified as 2 injuries, 2 malfunctions.

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

• MalfunctionJun 1, 2023Use of Device Problem; Improper or Incorrect Procedure or Method; Use of Device Problem; Improper or Incorrect Procedure or Method

  AS INITIALLY REPORTED TO CUSTOMER RELATIONS: A PATIENT OF UNSPECIFIED GENDER AND AGE UNDERWENT AN UNSPECIFIED PROCEDURE PREVIOUSLY IN WHICH THE ZILVER VENA VENOUS SELF-EXPANDING STENT, G57453, WAS USED. ON APRIL (B)(6)2023 IT WAS NOTED THAT THE STENT HAD MIGRATED INTO THE PATIENT'S HEART. THE PATIENT IS DOING OKAY. (PR (B)(6). UPDATED INFORMATION: NOTED DURING OTHER PROCEDURE, ULTRASOUND DONE AT 1 MONTH AND 6 MONTHS AND THESE IMAGES CAN BE SHARED. AS PER PR (B)(6) A 9FR SHEATH WAS USED. AS PER IFU0091, AN ACCESS SHEATH THAT ACCEPTS A 7FR INTRODUCER CATHETER IS RECOMMENDED. PATIENT OUTCOME: NO ADVERSE EVENTS REPORTED AS A RESULT OF THIS OCCURRENCE PATIENT/EVENT INFO - NOTES: PREFIX ZVT7 3.91 ARE IMAGES OF THE DEVICE OR PROCEDURE AVAILABLE? YES 3.92 DID THE PATIENT HAVE PRE-EXISTING CONDITIONS? YES IF YES, PLEASE SPECIFY: HISTORY OF HTN, AFIB, VARICOSE VEINS, MAY-THURNER, ANXIETY 3.93 PLEASE DESCRIBE THE NATIVE STATE OF THE VESSEL (I.E. WAS THE ANATOMY TORTUOUS? NOT TORTUOUS WAS THE VESSEL FIBROTIC?) NO IF OTHER, PLEASE SPECIFY: 3.94 WAS A STENT PREVIOUSLY PLACED DURING PREVIOUS PROCEDURES? NO 3.95 WAS THE DEVICE USED PERCUTANEOUSLY? YES 3.96 WHERE ON THE PATIENT WAS THE PERCUTANEOUS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17037198 ↗
• InjuryMay 22, 2023Migration; Migration

  AS INITIALLY REPORTED TO CUSTOMER RELATIONS:A PATIENT OF UNSPECIFIED GENDER AND AGE UNDERWENT AN UNSPECIFIED PROCEDURE PREVIOUSLY IN WHICH THE ZILVER VENA VENOUS SELF-EXPANDING STENT, G57453, WAS USED.ON (B)(6) 2023 IT WAS NOTED THAT THE STENT HAD MIGRATED INTO THE PATIENT'S HEART. THE PATIENT IS DOING OKAY.UPDATED INFORMATION:NOTED DURING OTHER PROCEDURE, ULTRASOUND DONE AT 1 MONTH AND 6 MONTHS AND THESE IMAGES CAN BE SHARED.ADDITIONAL INFORMATION RECEIVED (B)(6) 2023: ADDITIONAL QUESTIONS ANSWERED. INCORRECT SIZE ACCESS SHEATH USED. ADDITIONAL FILE REQUESTED. PATIENT OUTCOME:1. DID ANY UNINTENDED SECTION OF THE DEVICE REMAIN INSIDE THE PATIENT¿S BODY? YES.IF YES, PLEASE DESCRIBE. STENT IN RIGHT ATRIUM ACROSS VALVE.2. WAS THE PATIENT HOSPITALIZED OR WAS THERE PROLONGED HOSPITALIZATION? WILL BE HOSPITALIZED FOR PROCEDURE TO REMOVE DEVICE, DATE YET TO BE DETERMINED.3. DID THE PATIENT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE? YES.IF YES, PLEASE DESCRIBE. YES, WILL REQUIRE STERNOTOMY TO REMOVE DEVICE.4. DID THE PRODUCT CAUSE OR CONTRIBUTE TO THE NEED FOR ADDITIONAL PROCEDURES? YES.IF YES, PLEASE SPECIFY ADDITIONAL PROCEDURES AND PROVIDE DETAILS. YES, WILL REQUIR

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 16972870 ↗
• InjuryMay 11, 2023Migration; Migration

  ACCORDING TO THE INITIAL REPORTER: A PATIENT OF UNSPECIFIED GENDER AND AGE UNDERWENT AN UNSPECIFIED PROCEDURE PREVIOUSLY IN WHICH THE ZILVER VENA VENOUS SELF-EXPANDING STENT, G57453, WAS USED. ON (B)(6) 2023 IT WAS NOTED THAT THE STENT HAD MIGRATED INTO THE PATIENT'S HEART. THE PATIENT IS DOING OKAY. UPDATED INFORMATION: NOTED DURING OTHER PROCEDURE, ULTRASOUND DONE AT 1 MONTH AND 6 MONTHS AND THESE IMAGES CAN BE SHARED.

  Patient problems: Insufficient Information

  MAUDE report 16910634 ↗
• MalfunctionDec 30, 2020Off-Label Use; Use of Device Problem; Activation, Positioning or Separation Problem; Off-Label Use; Use of Device Problem; Activation, Positioning or Separation Problem

  SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 11095910 ↗