Zilver Vena G57446Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10827002574462), received between Jul 8, 2021 and Dec 16, 2022 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (1 report).

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.

• MalfunctionDec 16, 2022Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  AS INITIALLY REPORTED TO CUSTOMER RELATIONS VIA PHONE: A FEMALE PATIENT UNDERWENT A LEFT LEG VENOUS ILIAC STENTING PROCEDURE IN WHICH THE ZILVER VENA VENOUS SELF-EXPANDING STENT, G57446, WAS USED. WHILE ATTEMPTING TO DEPLOY THE DEVICE IT WAS NOTED THAT THERE WAS SO MUCH TENSION THAT THE STENT WOULD NOT COME OUT OF THE SHEATH. TO KEEP FROM THE STENT JUMPING THE DISTRICT MANAGER REQUESTED THE PHYSICIAN REMOVE THE DEVICE AND ANOTHER OF THE SAME DEVICE, G57446, WAS USED TO COMPLETE THE PROCEDURE WITH NO FURTHER COMPLICATIONS. USER ERROR BASED ON ANSWERS TO QUESTIONS - DID THE USER PULL THE HANDLE TOWARDS THE HUB DURING DEPLOYMENT, PER IFU? NO. DID THE USER PUSH THE HUB DURING DEPLOYMENT? NO. 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? 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 OC

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15994862 ↗
• MalfunctionJun 9, 2022Off-Label Use; Deformation Due to Compressive Stress; Off-Label Use; Deformation Due to Compressive Stress

  AS REPORTED TO CUSTOMER RELATIONS VIA PHONE CONVERSATION "WHEN THE STENT WAS DEPLOYED - IT SEEMED SHORTER THAN IT SHOULD BE. THEREFORE, IVUS WAS USED TO MEASURE THE DEVICE. IVUS CONFIRMED THAT THE STENT WAS APPROXIMATELY 2MM'S SHORTER THAN IT SHOULD HAVE BEEN. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH THE STENT (EVEN THOUGH IT WAS SHORTER THAN EXPECTED)." "DID ANY UNINTENDED SECTION OF THE DEVICE REMAIN INSIDE THE PATIENT¿S BODY?" NO. "DID THE PATIENT EXPERIENCE A DELAY OR REQUIRE ANY ADDITIONAL PROCEDURE DUE TO THIS OCCURRENCE?" NO. "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. "ARE IMAGES OF THE DEVICE OR PROCEDURE AVAILABLE?" YES. "DID THE PATIENT HAVE PRE-EXISTING CONDITIONS?" SEE ABOVE. PLEASE DESCRIBE THE NATIVE STATE OF THE VESSEL (I.E. WAS THE ANATOMY TORTUOUS? - NO WAS THE VESSEL FIBROTIC?) N/A, TORTUOUS, CALCIFIED, FIBROTIC, OTHER. IF OTHER, PLEASE SPECIFY: NO. "WAS A STENT PREVIOUSLY PLACED DURING PREVIOUS PROCEDURES?" YES. "WAS THE DEVICE USED PERCUTANEOUSLY?" YES. "WHERE ON THE PATIENT WAS THE PERCUTANEOUS ACCESS SITE?" P

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14643674 ↗
• MalfunctionJul 8, 2021Activation, Positioning or Separation Problem; Physical Resistance/Sticking; Activation, Positioning or Separation Problem; Physical Resistance/Sticking

  SUPPLEMENTAL REPORT IS BEING SUBMITTED AS A CANCELLATION REPORT AS THE EVENT DOES NOT MEET THE CRITERIA OF AN FDA ¿SERIOUS INJURY¿ REPORT OR ¿MALFUNCTION¿ REPORT AS PER FDA GUIDELINES ¿MEDICAL DEVICE REPORTING FOR MANUFACTURERS (2016).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12133734 ↗