Zilver Vena G57438Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10827002574387), received between Sep 16, 2021 and Sep 16, 2021 — classified as 2 injuries.

The most frequently reported specific device problem is “Off-Label Use” (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 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.

• InjurySep 16, 2021Off-Label Use; Off-Label Use

  SUPPLEMENTAL REPORT IS BEING SUBMITTED AS THE DEVICE WAS RETURNED AND EVALUATED ON THE 14 OCT AND DUE TO THE COMPLETION OF THE INVESTIGATION ON 22-OCT

  Patient problems: Stroke/CVA; Thrombosis/Thrombus

  MAUDE report 12480335 ↗
• InjurySep 16, 2021Break; Off-Label Use; Break; Off-Label Use

  ACCORDING TO THE INITIAL REPORTER: ((B)(4)) "UPON REMOVAL, THE DEVICE GOT STUCK ON THE WIRE. THE PHYSICIAN PULLED (AND WHEN HE PULLED) - IT BROKE THE INNER CATHETER OFF. IT WAS NOT REALIZED THE INNER CATHETER WAS BROKEN-OFF. THE PHYSICIAN GOT THE DEVICE OFF THE WIRE AND ATTEMPTED TO PUT A BALLOON OVER THE WIRE AND THE BALLOON GOT STUCK AT THE SAME POINT WHERE THE STENT GOT STUCK (OUTSIDE OF THE BODY). THE PHYSICIAN TOOK THE BALLOON OFF AND TRIED TO DO THE SAME THING WITH A 6FR CORDIS MPA AND THAT ALSO GOT STUCK AT THE SAME PLACE ON THE WIRE (THIS STILL OCCURRED OUTSIDE THE BODY). THEN, THE PHYSICIAN WENT IN WITH A 6FR GUIDE (WHICH HAS A LARGER LUMEN), THIS DID PASS THE DIFFICULT LOCATION ON THE WIRE. ONCE HE HAD THE GUIDE DOWN HE REMOVED THE COMPLAINT WIRE AND ATTEMPTED A WIRE EXCHANGE, BUT THE WIRE WOULD NOT GO ALL THE WAY THROUGH THE GUIDE. A THIS POINT, THE ENTIRE SYSTEM WAS REMOVED (REMOVING THE GUIDE AND THE WIRE AS WELL). LATER, THE PHYSICIAN FOUND OUT THE INNER CATHETER OF THE STENTS' DELIVERY WAS STILL LODGED INSIDE THE GUIDE. THE PHYSICIAN CUT THE INNER LUMEN LOOKING FOR PIECES. ((B)(4)) - AT THIS POINT HE REGAINED HIS ACCESS WITH A NEW STENT AND THE NEW STENT DEPLOYED FIN

  Patient problems: Stroke/CVA

  MAUDE report 12480332 ↗