Zilver Vena G57445Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10827002574455), received between Dec 17, 2020 and Jul 9, 2024 — classified as 5 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 9, 2024Structural Problem; Structural Problem

  SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION ON 22-JAN-2025.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19701602 ↗
• MalfunctionAug 17, 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 17563750 ↗
• 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 (B)(6) 2023. SG (B)(6) 2023 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) 2023. SG (B)(6) 2023 CASE WAS SUCCESSFUL, NO PROBLEMS 3.9

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

  MAUDE report 17450772 ↗
• InjuryJul 28, 2023Migration; Migration

  ACCORDING TO THE INITIAL REPORTER: 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 17412548 ↗
• MalfunctionDec 1, 2022Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  PER REP ON (B)(6) 2022: THEY HAD ACCESS WITH A BOSTON SCIENTIFIC AMPLATZ WIRE (.035, 260 CM). THEY HAD A CORDIS SHEATH 11 FR IN. THEY FLUSHED THE DEVICE AND WIRE. THEY TRIED TO ADVANCE THE COOK STENT OVER THE WIRE AND IT GOT STUCK AFTER ABOUT 30 CM OF GOING OVER THE WIRE. THEY REMOVED THE STENT DEVICE FROM WIRE AND FLUSHED IT AGAIN. THEY TRIED AGAIN TO GO OVER WIRE AND THE SAME THING HAPPENED BUT THE TIP OF THE STENT ALSO BECAME LOOSE AT THIS POINT DUE TO FRICTION WITH THE WIRE. THE STENT DEVICE DID NOT GO THROUGH THE SHEATH AT ANY POINT. THEY REMOVED THIS STENT DEVICE AND SUCCESSFULLY COMPLETED THE PROCEDURE WITH ANOTHER DEVICE OF THE SAME TYPE. PER REP ON (B)(6) 2022: I WAS IN THIS PROCEDURE AND AS I RECALL, THIS DEVICE WAS NOT INSPECTED BEFORE OR AFTER THE PROCEDURE FOR ANY DAMAGE. FILE REQUIRED TO CAPTURE USER ERROR AS NOT INSPECTED BEFORE USE. PATIENT OUTCOME: DID ANY UNINTENDED SECTION OF THE DEVICE REMAIN INSIDE THE PATIENT¿S BODY? NO. 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. DID THE PRODUCT CAUSE OR CONTRIBUTE TO THE NEED FOR ADDITIONAL PROCED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15893484 ↗
• MalfunctionMar 23, 2022Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE ADDITIONAL INFORMATION BEING RECEIVED. (B)(4):"THE DEVICE DID NOT MALFUNCTION. THE DOCTOR IS NOT HAPPY WITH HOW IT PERFORMED: DOCTOR'S WORDS (RELAYED TO DM) AR THAT THE SCAFFOLDING IS TOO FAR APART, THE CLOT CAME BACK INTO THE STENT. USER WAS HAVING ANOTHER STENT (WALL STENT) BROUGHT IN TO BE USED, BUT DM DIDN'T STICK AROUND FOR THAT." ADDITIONAL INFO RECEIVED 12-DEC-2020: "INITIALLY, THE STENT JUMPED DISTAL EARLY IN THE DEPLOYMENT AND WAS PULLED BACK GENTLY TO PROPER LOCATION". THIS FILE HAS BEEN OPENED TO CAPTURE USER ERROR - USER PULLED PARTIALLY DEPLOYED STENT BACK TO TARGET LOCATION SUBSEQUENT TO STENT JUMP DURING DEPLOYMENT. 1. DID ANY UNINTENDED SECTION OF THE DEVICE REMAIN INSIDE THE PATIENT¿S BODY? NO ¿ IF YES, PLEASE DESCRIBE. 2. WAS THE PATIENT HOSPITALIZED OR WAS THERE PROLONGED HOSPITALIZATION DUE TO THIS OCCURRENCE? NO. ¿ IF YES, PLEASE DESCRIBE. 3. DID THE PATIENT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE? YES,, AN ADDITIONAL BOSTON VICI STENT WAS PLACED. ¿ IF YES, PLEASE DESCRIBE. 4. DID THE PRODUCT CAUSE OR CONTRIBUTE TO THE NEED FOR ADDITIONAL PROCEDURES? ¿ IF YES, PLEASE SPECIFY ADDITIONAL PROCEDURE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13870606 ↗
• MalfunctionJan 5, 2022Fracture; Difficult to Remove; Fracture; Difficult to Remove

  COMPLAINT CALLED IN BY DM ON 15NOV2021--DID 15NOV2021. AS REPORTED TO CUSTOMER RELATIONS: "THE WIRE GOT STUCK. NO ADVESRSE EVENT, NO INTERVENTIONS NEEDED, THEY WERE ABLE TO PULL IT OUT, THEY GOT ANOTHER OF THE SAME GPN TO USE INSTEAD. LAB EVALUATION COMPLETED ON 10-DEC-2021: KINK ON OUTER SHEATH AT DISTAL END OF HANDLE. DAMAGE / CRINKLING ON OUTER SHEATH INNER CATHETER BROKEN AND RETURNED REMOVED FROM DELIVERY SYSTEM ON THE PROCEDURAL WIRE GUIDE. PATIENT OUTCOME: 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. IF YES, PLEASE DESCRIBE. 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. PATIENT/EVENT INFO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13169255 ↗
• InjuryJun 23, 2021Activation, Positioning or Separation Problem; Material Twisted/Bent; Adverse Event Without Identified Device or Use Problem; Activation Failure; Activation, Positioning or Separation Problem; Material Twisted/Bent; Adverse Event Without Identified Device or Use Problem; Activation Failure

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

  Patient problems: Failure of Implant

  MAUDE report 12047431 ↗
• InjuryJun 21, 2021Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  AS INITIALLY REPORTED TO CUSTOMER RELATIONS: A FEMALE PATIENT OF UNDISCLOSED AGE UNDERWENT A BILATERAL VENOUS STENTING PROCEDURE IN WHICH THE ZILVER VENA VENOUS SELF-EXPANDING STENT, G57445, WAS USED. THE RIGHT SIDE DEPLOYED AS INTENDED. THE LEFT SIDE AFTER DEPLOYMENT THE STENT DID NOT FULLY EXPAND. THE PHYSICIAN ATTEMPTED TO BALLOON THE STENT BUT IT STILL LOOKED DEFORMED. THE PHYSICIAN THEN REALIGNED WITH A WALL STENT AND ALIGNMENT LOOKED BETTER. PHYSICIAN NOTED THE LEFT SIDE HAD A HARD LESION.

  Patient problems: Failure of Implant

  MAUDE report 12031807 ↗
• MalfunctionDec 18, 2020Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

  THIS REPORT IS BEING SUBMITTED AS A CANCELLATION REPORT FOLLOWING CONCLUSION OF INVESTIGATION ON THE 27-SEP-2021. THIS COMPLAINT IS CONSIDERED NEGATIVE FEEDBACK. NO PRODUCT MALFUNCTION OR PATIENT INJURY/ ADVERSE EFFECTS TO THE PATIENT WAS REPORTED AS OCCURRING. 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; No Known Impact Or Consequence To Patient

  MAUDE report 11035736 ↗
• InjuryDec 17, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE PHYSICIAN, "THE SCAFFOLDING IS TOO FAR APART, THE CLOT CAME BACK INTO THE STENT. USER WAS HAVING ANOTHER STENT (WALL STENT) BROUGHT IN TO BE USED". THE STENT WAS BEING PLACED VIA THE COMMON FEMORAL VEIN. FURTHER INFORMATION PROVIDED STATES, "WHEN THE STENT BEGAN IT¿S DEPLOYMENT THE SYSTEM JUMPED BACK ALMOST AS IF THE WIRE WAS NO STIFF ENOUGH, ON THE SECOND STENT WE USED A LUNDERQUIST WIRE WHICH STABILIZED THE SYSTEM A BIT MORE". THE DELIVERY SYSTEM HELD STRAIGHT AND STILL DURING DEPLOYMENT, HOWEVER THE PHYSICIAN COMMENTED THAT THE PINNING THE METAL CANNULA/HUB AT THE BACK END SEEMED WOBBLY. FURTHERMORE, THE STENT JUMPED DISTAL EARLY IN THE DEPLOYMENT AND WAS PULLED BACK GENTLY TO PROPER LOCATION.

  Patient problems: No Code Available

  MAUDE report 11030141 ↗