Zilver Vena G57447Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10827002574479), received between Sep 22, 2021 and Sep 6, 2023 — classified as 7 injuries, 2 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 16, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 6, 2023Activation Problem; Activation Problem

  SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION ON 25-APR-2024.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17694984 ↗
• MalfunctionSep 5, 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: TWO STENTS WERE PLACED DURING A VENAGRAM PROCEDURE. THE SECOND STENT LOOKED MANGLED AND KINKED WHEN PLACING AND DID NOT OPEN AND SMOOTH OUT AS NORMAL. THE PHYSICIAN DID AN ANGIO WITH A 14 ATLAS BALLOON. WHILE IT DID HELP TO OPEN AND STRAIGHTEN, THE STENT WAS STILL NOT AS OPEN AND STRAIGHT AS IT SHOULD BE. THIS FILE WILL CAPTURE THE USE OF A 8FR ANSEL ACCESS SHEATH. 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 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 3.91 ARE IMAGES OF THE DEVICE OR PROCEDURE AVAILABLE? YES. SEE ATTACHMENTS. 3.92 DID THE PATIENT HAVE PRE-EXISTIN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17682016 ↗
• InjuryApr 26, 2022Improper or Incorrect Procedure or Method; Migration; Improper or Incorrect Procedure or Method; Migration

  AS INITIALLY REPORTED TO CUSTOMER RELATIONS VIA PHONE: A MALE PATIENT OF UNSPECIFIED AGE UNDERWENT AN ILIAC VEIN STENTING PROCEDURE IN WHICH THE ZILVER VENA VENOUS SELF-EXPANDING STENT, G57447, WAS USED. PRIOR TO STENT PLACEMENT THE PHYSICIAN USED AN INARI MEDICAL DEVICE AND WAS ABLE TO PULL OUT A LOT OF THE CLOT. THE PHYSICIAN DEPLOYED THE STENT IN THE ILIAC AND WHEN WENT TO DO AN ULTRASOUND IT WAS NOTED THE STENT HAD PUSHED UP OR TRAVELED UP TO THE IVC. A WIRE WAS USED TO GO UP THROUGH AND HOOK ONTO THE STENT AND THE PHYSICIAN WAS THEN ABLE TO PULL THE STENT BACK DOWN TO THE EXTERNAL ILIAC. A BOSTON SCIENTIFIC WALL STENT WAS THEN DEPLOYED INSIDE OF THE ZILVER. PREFIX ZVT7. ARE IMAGES OF THE DEVICE OR PROCEDURE AVAILABLE? REQUESTED FROM DISTRICT MANAGER. DID THE PATIENT HAVE PRE-EXISTING CONDITIONS? NONE SPECIFIED BY END USER. IF YES, PLEASE SPECIFY: PLEASE DESCRIBE THE NATIVE STATE OF THE VESSEL (I.E. WAS THE ANATOMY TORTUOUS? THROMBOSED. WAS THE VESSEL FIBROTIC?) N/A, TORTUOUS, CALCIFIED, FIBROTIC, OTHER. IF OTHER, PLEASE SPECIFY: WAS A STENT PREVIOUSLY PLACED DURING PREVIOUS PROCEDURES? NO, THIS IS THE ONLY PROCEDURE TO DATE. WAS THE DEVICE USED PERCUTANEOUSLY? YES. WHERE ON TH

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 14204722 ↗
• InjuryApr 21, 2022Migration; Migration

  ACCORDING TO THE INITIAL REPORTER: A MALE PATIENT OF UNSPECIFIED AGE UNDERWENT AN ILIAC VEIN STENTING PROCEDURE IN WHICH THE ZILVER VENA VENOUS SELF-EXPANDING STENT, G57447, WAS USED. PRIOR TO STENT PLACEMENT THE PHYSICIAN USED AN (ANOTHER MANUFACTURER'S) MEDICAL DEVICE AND WAS ABLE TO PULL OUT A LOT OF THE CLOT. THE PHYSICIAN DEPLOYED THE STENT IN THE ILIAC AND WHEN WENT TO DO AN ULTRASOUND IT WAS NOTED THE STENT HAD PUSHED UP OR TRAVELED UP TO THE IVC. A WIRE WAS USED TO GO UP THROUGH AND HOOK ONTO THE STENT AND THE PHYSICIAN WAS THEN ABLE TO PULL THE STENT BACK DOWN TO THE EXTERNAL ILIAC. A (ANOTHER MANUFACTURER'S) WALL STENT WAS THEN DEPLOYED INSIDE OF THE ZILVER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14167227 ↗
• InjuryDec 21, 2021Migration; Migration

  REPORTED BY THE DM ON BEHALF OF THE CUSTOMER VIA EMAIL, WE HAD MULTIPLE PRODUCT ISSUES IN A CASE THIS MORNING WITH DR. (B)(6). WE USED TWO DIFFERENT BENTSON WIRES THAT EACH GOT EASILY KINKED AND STUCK IN THE CATHETERS DESPITE BEING WET AND APPROPRIATELY PREPPED. THE BENTSON WIRES WERE THE SAME PART NUMBER (G01290) HOWEVER THEY WERE FROM DIFFERENT LOTS. IN THE SAME CASE WE ALSO HAD AN ISSUE WITH A ZILVER VENA STENT 16X60 (G57447) LOT C1847299 WHICH WAS SUCCESSFUL DEPLOYED HOWEVER AFTER POST DILATION WITH A BOSTON XXL 16X60 BALLOON UPON REMOVAL OF THE BALLOON (WHICH ON ANGIO APPEARED TO BE DEFLATED) THE STENT WAS PULLED DOWN INTO THE EXTERNAL/COMMON FEMORAL VEIN. IN AN ATTEMPT TO RE-EXPAND THE SECOND STENT WHICH WAS PULLED BACK THE DOCTOR DEPLOYED A ZILVER VENA 14X60 (G57444) LOT C1841687 WHICH SUCCESSFULLY OPENED AND ANCHORED THE VENA STENT THAT HAD BEEN DRAGGED BACK BY THE XXL BALLOON. A THIRD ZILVER VENA HAD TO BE PLACED (16X100 G57448 LOT C1850657) IN THE INTENDED AREA OF COMPRESSION IN THE COMMON ILIAC VEIN BECAUSE THE STENT WAS DRAGGED INTO THE EXTERNAL/ COMMON). THE PATIENT WAS FINE AND NO SECONDARY PROCEDURES WERE NECESSARY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13051514 ↗
• InjuryOct 5, 2021Fracture; Fracture

  AS INSTRUCTED FROM CIRL "ACCESS WAS RIGHT AND LEFT FEMORAL VEIN, AND JUGULAR VEIN WITH 18FR X 35CM COOK SHEATHS IN BOTH THE IJ & RIGHT FEMORAL VEIN. THERE WAS AN 8 FR SHEATH IN THE LEFT FEMORAL VEIN. THE PATIENT HAD A 10-YEAR-OLD CELET IVC FILTER IN THAT WAS REMOVED PRIOR TO PLACING STENTS. ONCE REMOVED, THE PHYSICIAN USES IVUS TO MEASURE THE IVC WHICH MEASURED A 14.2MM DIAMETER. HE DECIDED TO PLACE A 16X60 ZILVER VENA IN THE IVC RIGHT AT THE CONFLUENCE FROM THE RIGHT FEMORAL VEIN. THEN FOLLOWED THAT STENT WITH TWO 14X140 STENTS IN THE COMMON ILIAC VEINS. THESE WERE ALL PLACED FROM THE FEMORAL VEIN ACCESS. THE PHYSICIAN USED IVUS AGAIN TO CONFIRM PLACEMENT. HE THEN HAD TO RETRIEVE A PIECE OF FILTER THAT HAD BROKEN OFF IN THE LIVER DURING THE IVC FILTER RETRIEVAL AND REALIZED THE ZILVER VENA STENT THAT WAS PLACED IN THE IVC HAD MIGRATED UP HIGHER IN THE IVC. ((B)(4)) HE DID MENTION IT COULD HAVE BEEN DRAGGED UP FROM THE CATHETER HE WAS USING TO RETRIEVE THE PIECE OF IVC FILTER. THE PHYSICIAN TRIED PUSHING THE STENT DOWN WITH A LARGE SNARE THEN DECIDED IT NEEDED TO COME OUT. HE USED THE LARGE SNARE FROM BOTH ABOVE AND BELOW THROUGH THE 18FR SHEATHS TO SNARE AND REMOVE THE ZILVER VENA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12575690 ↗
• InjurySep 23, 2021Fracture; Off-Label Use; Fracture; Off-Label Use

  SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO ADDITIONAL INFORMATION RECEIVED ON 30-DEC-2021. CONFIRMATION RECEIVED FROM CLINICAL THAT USE OF THE VENA STENT IN THE IVC IS OFF-LABEL, THIS SUPPLEMENT REPORT IS BEING SUBMITTED TO UPDATE THE IMDRF A CODE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12517679 ↗
• InjurySep 23, 2021Off-Label Use; Migration; Off-Label Use; Migration

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12517674 ↗
• InjurySep 22, 2021Fracture; Fracture

  "ACCESS WAS RIGHT AND LEFT FEMORAL VEIN, AND JUGULAR VEIN WITH 18FR X 35CM COOK SHEATHS IN BOTH THE IJ & RIGHT FEMORAL VEIN. THERE WAS AN 8 FR SHEATH IN THE LEFT FEMORAL VEIN. THE PATIENT HAD A 10-YEAR-OLD CELET IVC FILTER IN THAT WAS REMOVED PRIOR TO PLACING STENTS. ONCE REMOVED, THE PHYSICIAN USES IVUS TO MEASURE THE IVC WHICH MEASURED A 14.2MM DIAMETER. HE DECIDED TO PLACE A 16X60 ZILVER VENA IN THE IVC RIGHT AT THE CONFLUENCE FROM THE RIGHT FEMORAL VEIN. THEN FOLLOWED THAT STENT WITH TWO 14X140 STENTS IN THE COMMON ILIAC VEINS. THESE WERE ALL PLACED FROM THE FEMORAL VEIN ACCESS. THE PHYSICIAN USED IVUS AGAIN TO CONFIRM PLACEMENT. HE THEN HAD TO RETRIEVE A PIECE OF FILTER THAT HAD BROKEN OFF IN THE LIVER DURING THE IVC FILTER RETRIEVAL AND REALIZED THE ZILVER VENA STENT THAT WAS PLACED IN THE IVC HAD MIGRATED UP HIGHER IN THE IVC. HE DID MENTION IT COULD HAVE BEEN DRAGGED UP FROM THE CATHETER HE WAS USING TO RETRIEVE THE PIECE OF IVC FILTER. THE PHYSICIAN TRIED PUSHING THE STENT DOWN WITH A LARGE SNARE THEN DECIDED IT NEEDED TO COME OUT. HE USED THE LARGE SNARE FROM BOTH ABOVE AND BELOW THROUGH THE 18FR SHEATHS TO SNARE AND REMOVE THE ZILVER VENA STENT FROM THE PATIENT. THE STEN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12514477 ↗