Zilver Vena G57444Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10827002574448), received between Jun 9, 2021 and Jun 11, 2021 — classified as 2 injuries.

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

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJun 11, 2021Improper or Incorrect Procedure or Method; Migration; Improper or Incorrect Procedure or Method; Migration

  SUPPLEMENTAL FOLLOW-UP REPORT IS BEING SUBMITTED DUE TO THE RECEIPT OF IMAGE REVIEW. IMAGE REVIEW RECEIVED 9-AUG-2021: IS THE COMPLAINT CONFIRMED? (SEE DESCRIPTION OF EVENT ON COMPLAINT REPORT) NO OR YES. FINDINGS: 1. IMPLANTATION ANGIOGRAPHY AND IVUS ARE PROVIDED ALONG WITH THE COMPLAINT REPORT. 2. THE COMPLAINT CONCERNS ZVT7-35-80-14-60 PULMONARY ARTERY EMBOLIZATION TWO DAYS POST IMPLANTATION. THE STENT WAS REPORTEDLY RETRIEVED. THE COMPLAINT REPORT IMPLIES THAT THE RETRIEVED STENT WAS FILLED WITH THROMBUS. 3. THE STENT WAS IMPLANTED FROM THE RIGHT IJ. THE PRE-STENT IVUS WAS PERFORMED IN PULL BACK FASHION FROM THE LEFT EIV TO THE IVC. 4. THE IMPLANTATION SITE WAS THE DISTAL LEFT CIV FROM THE EIV/IIV CONFLUENCE TO JUST INFERIOR TO THE RIGHT CIA CROSSING. (FIGURE 1) 5. ON VENOGRAPHY, THE CIV VEIN SEGMENT WAS 14MM X 16MM IN TWO PROJECTIONS. (FIGURE 1 & FIGURE 2) 6. ON PRE-STENT IVUS, THE CIV SEGMENT WAS A FLATTENED ELLIPSE WITH A 50% AREA STENOSIS. NO INTRAVENOUS SYNECHIAE OR WEBS WERE DEMONSTRATED. THE ADJACENT VEIN DIAMETER WAS 15MM. (FIGURE 3) THE SEGMENT WAS ADJACENT TO THE LEFT CIA AND INFERIOR TO THE RIGHT CIA CROSSING. (FIGURE 4) 7. ON POST-STENT IMPLANTATION VENOGRAPHY, ALTH

  Patient problems: Chest Pain; Respiratory Insufficiency; Thrombosis/Thrombus

  MAUDE report 11981276 ↗
• InjuryJun 9, 2021Migration or Expulsion of Device

  ACCORDING TO THE INITIAL REPORTER: "STENT IS ALREADY DEPLOYED IN THE PATIENT. THE PROCEDURE WENT GREAT ON TUESDAY; DOCTOR TEXTED (COOK REPRESENTATIVE) TODAY THAT THE PATIENT CALLED IN; PATIENT WAS SUPPOSED TO BE COMING IN FOR A DUPLEX ULTRASOUND AND, WHILE PUTTING ON HIS SHOES, PATIENT EXPERIENCED CHEST PAIN AND SHORTNESS OF BREATH. AT THAT POINT THE DOCTOR TOLD THE PATIENT TO COME INTO THE E.R. IN E.R., THEY OBSERVED THAT THE STENT HAD MIGRATED TO LEFT PULMONARY ARTERY. DOCTOR BELIEVES THAT THE STENT PROBABLY THROMBOSED PRIOR TO EMBOLIZATION. PATIENT WAS FULLY ANTICOAGULATED (BELIEVED TO BE DURING THE PROCEDURE). DOCTOR SAID THAT THE PATIENT HAD NO UNDERLYING CLOTTING DISORDER AND WAS SEEN BY HEMATOLOGY. NO BREAKAGE OF THE DEVICE HAS BEEN OBSERVED. IT WAS FURTHER REPORTED THAT THE STENT WAS REMOVED. IT WAS FURTHER REPORTED: "PATIENT WIFE SAID HE HAS AN ALLERGY TO BEE VENOM, CT WAS DONE AFTERWARDS; ILIAC VEIN WAS CLEAN. POSSIBLE UNKNOWN ALLERGY TO STENT METAL? THROMBOSIS CAME FIRST; MAYBE AN ALLERGIC REACTION WITH AN ODD INFLAMMATORY RESPONSE UNDER STENT; WAS NOT ABLE TO ENDOTHELIALIZE TO VESSEL WALLS."

  Patient problems: Chest Pain; Respiratory Insufficiency

  MAUDE report 11964742 ↗