Zilver 635 G43858Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10827002438580), received between Sep 22, 2016 and Sep 15, 2022 — classified as 2 injuries, 3 malfunctions.

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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 15, 2022Improper or Incorrect Procedure or Method; Device Damaged Prior to Use; Improper or Incorrect Procedure or Method; Device Damaged Prior to Use

  THE DEVICE WAS TO BE USED FOR EVT IN THE LEFT ILIAC ARTERY BY LEFT GROIN APPROACH. HOWEVER, THE STENT GOT DEPLOYED SPONTANEOUSLY DURING PREPARATION, SO ANOTHER ZIV6-35-80-8-60 WAS USED INSTEAD. THERE HAVE BEEN NO ADVERSE EFFECTS TO THE PATIENT REPORTED. PHYSICIAN'S COMMENT: THE STENT WAS SPONTANEOUSLY DEPLOYED AT THE TIMING THAT I DID NOT INTEND. SALES REP'S COMMENT: WHEN THE DEVICE WAS RETURNED TO ME, I NOTICED THAT THE SAFETY LOCK WAS REMOVED. THEREFORE, I ASSUME THAT THE STENT GOT DEPLOYED AT THE TIMING THAT THE PHYSICIAN DID NOT INTEND. I TOLD THE PHYSICIAN NOT TO REMOVE THE SAFETLY LOCK UNTIL HE IS READY FOR DEPLOYMENT. PREFIX ZIV5/ZIV6/ WAS THE DEVICE USED PERCUTANEOUSLY? N/A - PRIOR TO PATIENT CONTACT, WHICH ARTERY WAS THE STENT TO BE PLACED IN? N/A - PRIOR TO PATIENT CONTACT, WAS THE APPROACH IPSILATERAL OR CONTRALATERAL? (IPSILATERAL), IF CONTRALATERAL, WAS THE BIFURCATION ANGLE TIGHT? WHERE ON THE PATIENT WAS THE PERCUTANEOUS ACCESS SITE? DETAILS OF ACCESS SHEATH USED (NAME, FR SIZE, LENGTH)? WAS THE DEVICE FLUSHED THROUGH BOTH FLUSHING PORT BEFORE THE PROCEDURE, AS PER IFU? YES. DETAILS OF THE WIRE GUIDE USED (NAME, DIAMETER, HYRDOPHYLLIC)? TERUMO RADIFOCUS RF-GA35263 .0

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15428859 ↗
• MalfunctionNov 18, 2020Off-Label Use; Off-Label Use

  IMAGE REVIEW COMPLETED ON (B)(6) 2021: IMPRESSION: 1. ALTHOUGH A ZILVER STENT WITH AN IMPLANTED LENGTH OF AT MOST 28.67MM IS CONFIRMED, THE ASSERTION THAT THE STENT WAS A ZIV6-35-40-8-80 IN A ZIV6-35-80-8-80 PACKAGE IS NOT CONFIRMED. 2. IT IS MUCH MORE LIKELY THAT THE STENT WAS IMPLANTED CONCERTINAED AND OR TELESCOPED. IT IS POSSIBLE GIVEN THE LOSS OF WIRE ACCESS THAT THIS OCCURRED OR WAS FURTHER EXACERBATED DURING ATTEMPTED REPEAT CANNULATION. FINDINGS CONSISTENT WITH EITHER A SEVERE CONCERTINAED OR TELESCOPED STENT CANNOT BE DISTINGUISHED FROM CALCIFICATION ON THE PROVIDED IMAGING. 3. DURING KISSING STENT IMPLANTATION, BOTH STENTS ARE POSITIONED AND ADJUSTED UNDER FLUOROSCOPY BEFORE SIMULTANEOUS DEPLOYMENT. THIS SCRUTINY WOULD HAVE RENDERED OBVIOUS ANY SHORTER THAN EXPECTED STENT PRIOR TO DEPLOYMENT. 4. A REVIEW OF THE LITERATURE FAILED TO FIND PEER REVIEWED DATA COMPARING KISSING SELF-EXPANDING STENTS, BALLOON EXPANDABLE STENTS, COVERED STENTS, OR A COMBINATION OF STENT TYPES FOR THIS TYPE OF LESION. HOWEVER, KISSING SELF-EXPANDING STENTING OF THIS HEAVILY CALCIFIED LONG DISTAL AORTO-ILIAC STENOSIS WITH MOUND-LIKE PLAQUE WOULD BE AN UNCOMMON APPROACH. THE MORE COMMON APPROACH WO

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

  MAUDE report 10859967 ↗
• InjuryNov 17, 2020Off-Label Use; Use of Device Problem; Off-Label Use; Use of Device Problem

  SUPPLEMENTAL REPORT BEING SUBMITTED DUE TO ADDITIONAL INFORMATION BEING RECEIVED ON 07-DEC-2020 REGARDING, DATE OF EVENT, PATIENT INFORMATION, TYPE OF PROCEDURE, INTERVENTION, PATIENT OUTCOME AND PATIENT/EVENT INFO-NOTES. THIS REPORT IS RELATED TO 3001845648-2020-00875. PER REP - 19OCT2020- PLEASE FIND THE BARCODE FOR AN 8X80 STENT THAT WAS USED BY (B)(6) LAST WEEK. I WAS NOT PRESENT AT THE CASE BUT APPARENTLY THE STENT WAS MIS-LABELED AS THE STENT WAS IN FACT AN 8-40 IN LENGTH AND NOT AN 8-80. NO ADDITIONAL PROCEDURES WERE NEEDED. I HAVE COPIED LAURA, THE RT ON THIS MESSAGE. SHE WAS NOT PRESENT WHEN THE INCIDENT OCCURRED HOWEVER SHE IS THE POINT OF CONTACT FOR THIS ACCOUNT. PER REP - 19OCT2020 - THEY DID IMPLANT IT. I DON¿T BELIEVE THEY REALIZED IT WAS THE WRONG SIZE UNTIL THEY IMPLANTED IT. PER CUSTOMER - (B)(6) 2020 - I WAS NOT PRESENT FOR THE CASE, BUT PER THE DOCTOR THE STENT WAS DEPLOYED AND THEN IT WAS NOTICED THAT IT WAS SHORTER. IT DOES NOT SEEM LIKELY THAT IT COMPRESSED OR SHORTENED DUE TO A KISSING STENT BEING DEPLOYED SIMULTANEOUSLY THAT SHOULD HAVE BEEN SHORTER (60MM) AND ENDED UP LOOKING LONGER. NO, THE STENT WAS NOT LONG ENOUGH AND TWO ADDITIONAL STENTS WERE REQUIRED

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions; No Information

  MAUDE report 10853780 ↗
• InjuryNov 11, 2020Inadequacy of Device Shape and/or Size; Device Markings/Labelling Problem; Inadequacy of Device Shape and/or Size; Device Markings/Labelling Problem

  ACCORDING TO THE INITIAL REPORTER, THE BARCODE FOR AN 8X80 STENT THAT WAS USED BY THE END USER LAST WEEK WAS APPARENTLY MIS-LABELED AS THE STENT WAS IN FACT AN 8-40 IN LENGTH AND NOT AN 8-80. NO ADDITIONAL PROCEDURES WERE NEEDED. IT WAS FURTHER REPORTED THAT THE STENT WAS IMPLANTED AND THEY DID NOT REALIZED IT WAS THE WRONG SIZE UNTIL THEY IMPLANTED IT. PER THE DOCTOR THE STENT WAS DEPLOYED AND THEN IT WAS NOTICED THAT IT WAS SHORTER. IT DOES NOT SEEM LIKELY THAT IT COMPRESSED OR SHORTENED DUE TO A KISSING STENT BEING DEPLOYED SIMULTANEOUSLY THAT SHOULD HAVE BEEN SHORTER (60MM) AND ENDED UP LOOKING LONGER. THE STENT WAS NOT LONG ENOUGH AND TWO ADDITIONAL STENTS WERE REQUIRED TO ACHIEVE A SATISFACTORY RESULT.

  Patient problems: No Code Available

  MAUDE report 10824029 ↗
• MalfunctionSep 22, 2016Difficult to Remove; Difficult to Remove

  THIS FOLLOW UP REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION INTO THIS EVENT. INITIAL DESCRIPTION SUBMITTED AS FOLLOWS: AFTER THEY DEPLOYED THE STENT, THEY COULD NOT REMOVE THE DELIVERY SYSTEM FROM OVER THE WIRE. THE WIRE AND THE DELIVERY SYSTEM HAD TO BE REMOVED TOGETHER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5969543 ↗