Zilver 635 G43867Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10827002438672), received between Jul 17, 2017 and Jan 27, 2021 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Difficult to Advance” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 27, 2021Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  SUPPLEMENTAL REPORT BEING SUBMITTED DUE TO THE INVESTIGATION BEING COMPLETED ON 30-APR-2021.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 11238283 ↗
• MalfunctionDec 21, 2020Structural Problem; Material Deformation; Structural Problem; Material Deformation

  THE USER ADVANCED THE DELIVERY SYSTEM OF THE DEVICE FROM THE LEFT FA TO THE LEFT EIA DURING EVAR TO PLACE THE STENT AT THE ILIAC LEG GRAFT. HOWEVER, THE STENT APPEARED TO HAVE BEEN DEPLOYED AND PLACED WITH DEFORMATION. THEREFORE, ANOTHER STENT WAS ADDITIONALLY PLACED. THERE HAVE BEEN NO ADVERSE EFFECTS TO THE PATIENT REPORTED. UPDATED ON 30/NOV/2020, (B)(4). THE USER ADVANCED THE DELIVERY SYSTEM OF THE DEVICE FROM THE LEFT FA TO THE LEFT EIA DURING EVAR TO PLACE THE STENT FROM INSIDE THE DISTAL SIDE OF THE ILIAC LEG GRAFT TO THE EIA. (THE ILIAC LEG GRAFT LANDED IN THE EIA.) HOWEVER, THE STENT APPEARED TO HAVE BEEN DEPLOYED AND PLACED WITH DEFORMATION. THEREFORE, CORDIS'S SMART F10¿ X 80MM WAS ADDITIONALLY PLACED INSIDE THE DEFORMED ZIV6-35-80-10-60 STENT TO THE DISTAL SIDE OF THE ZIV6 STENT. THE DEFORMATION COULD NOT BE RESOLVED, BUT THE INNER LUMEN APPEARED TO BE PATENT. THERE HAVE BEEN NO ADVERSE EFFECTS TO THE PATIENT REPORTED. PATIENT OUTCOME: THERE HAVE BEEN NO ADVERSE EFFECTS TO THE PATIENT REPORTED. PATIENT/EVENT INFO NOTES: 2 PREFIX ZIV5/ZIV6/ 2-1 WAS THE DEVICE USED PERCUTANEOUSLY? ¿¿(YES) 2-2 WHICH ARTERY WAS THE STENT TO BE PLACED IN? - EIA 2-3 WAS THE APPROACH IPSILATER

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 11046139 ↗
• MalfunctionApr 24, 2018Fracture; Fracture

  THIS FOLLOW UP REPORT IS BEING SUBMITTED TO UPDATE THE INVESTIGATION RESULTS. INITIAL MDR SUBMITTED BASED ON THE DEVICE MALFUNCTION PRECEDENCE: ¿STENT FRACTURE". AS REPORTED TO CUSTOMER RELATIONS, "THE STENT GOT STUCK ON A WIRE AND CAME APART ON THE WIRE. THEY WERE IN THE PROCESS OF REMOVING THE WIRE TO DO AN EXCHANGE BECAUSE IT WAS NOT LONG ENOUGH. THEY HAD TO TAKE THE WIRE AND STENT OUT TOGETHER. THEY OPENED A NEW ZILVER TO COMPLETE THE PROCEDURE SUCCESSFULLY."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7455467 ↗
• MalfunctionSep 13, 2017Difficult to Advance; Difficult to Advance

  EVT OF THE EIA WAS PERFORMED BY CONTRALATERAL APPROACH FROM CFA. ALTHOUGH THE PHYSICIAN ATTEMPTED TO MAKE THE DELIVERY SYSTEM OF THE COMPLAINT ZIV6-35-80-10-60 PASS THROUGH THE LESION, IT WOULD NOT. THE PROCEDURE WAS CANCELLED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6861341 ↗
• MalfunctionJul 17, 2017Failure to Advance; Failure to Advance

  THIS FOLLOW UP REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION INTO THIS EVENT AND THE CONCLUSION OF THIS INVESTIGATION. INITIAL REPORT DETAILS: ACCESS WAS GAINED FROM RIGHT FA TO THE LESION OF LEFT EIA CONTRALATERALLY. THE PATIENT'S ANATOMICAL FORM WERE SUITABLE FOR THE PROCEDURE, BUT TARGET LESION WAS SEVERELY CALCIFIED. DUE TO SEVERE CALCIFICATION, IT WAS DIFFICULT TO PASS THROUGH TO THE BIFURCATION AREA WITH THE GUIDING SHEATH (TERUMO/DESTINATION). AT THE LESION OF EIA, THERE WAS ALSO SEVERE CALCIFICATION SO THE LESION POORLY DILATED BY POBA. AFTER SEVERAL POBA PERFORMED, THE PHYSICIAN ATTEMPTED TO ADVANCE THE DELIVERY SYSTEM, HOWEVER, IT WOULD NOT PASS THOUGH THE LESION. SINCE THE PHYSICIAN ATTEMPTED TO ADVANCE THE DEVICE WITH FORCE MANY TIMES, AND ALSO THERE WAS A GAP BETWEEN TIP OF THE SHEATH AND WIRE GUIDE (0.014 INCH), THE TIP OF THE SHEATH GOT DEFORMED. THEREFORE, THE PROCEDURE WAS END WITH POBA WITHOUT PLACING THE STENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6716935 ↗