Zilver 635 G43823Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10827002438238), received between Mar 23, 2016 and Nov 9, 2023 — classified as 2 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 9, 2023Off-Label Use; Off-Label Use

  SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION ON 17-JAN-2024.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18100250 ↗
• MalfunctionDec 16, 2019Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  AS REPORTED TO CUSTOMER RELATIONS: "· CUSTOMER (B)(6) . · PHYSICIAN: DR. (B)(6) . · DATE OF PROCEDURE: (B)(6) 2019. . PATIENT INFO: UNAVAILABLE. . I WAS MADE AWARE OF THIS EVENT LATE ON 11/19/19 AND DISCUSSED DETAILS WITH THE PHYSICIAN ON 11/20/19. . TYPE OF PROCEDURE: DISTAL SFA STENT. · PRODUCTS: G43823 LOT: C1590801. · STENT WAS NOT DEPLOYED IN THE PATIENT AND IS AVAILABLE FOR RETURN. · PLEASE SENS NO CHARGE REPLACEMENT TO CUSTOMER ATTENTION TO (B)(6) . · ACKNOWLEDGMENT LETTER AND FOLLOW UP TO BE SENT TO ME AND I¿LL FOLLOW UP WITH PHYSICIAN. · EVENT: THROUGH A 7FR 45CM ANSEL SHEATH AND OVER A ROSEN WIRE, PHYSICIAN ATTEMPTED TO DEPLOY THE ZILVER STENT G43823 IN THE DISTAL SFA BUT STENT DID NOT DEPLOY. THE AREA TO BE STENTED WAS NOT CALCIFIED NOR TORTUOUS. AFTER CROSSING THE LESION, PHYSICIAN USED JETSTREAM ATHERECTOMY AND USED A 6MM BALLOON FOR PRE-DILITATION, THEN THE ZILVER STENT WAS PREPPED PER IFU AND ADVANCED OVER THE ROSEN WIRE PAST THE LESION, HE REMOVED THE SAFETY LOCK AND ATTEMPTED TO DEPLOY THE STENT, BUT FELT A LOT OF RESISTANCE AND STENT WOULDN¿T DEPLOY WITH EASE, HE DECIDED TO REMOVE THE UNDEPLOYED ZILVER STENT AND USED A DIFFERENT STENT, EPIC FROM BOSTON SCIENTIFIC,

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9472529 ↗
• MalfunctionMay 23, 2018Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  AS REPORTED TO CUSTOMER RELATIONS "THE PHYSICIAN HAD TROUBLE FINISHING THE DEPLOYMENT. THE STENT WAS MOSTLY DEPLOYED BUT WHEN THE HANDLE WAS PULLED BACK ALL THE WAY, THERE WAS STILL SOME STENT REMAINING INSIDE THE SHEATH. THE PHYSICIAN WAS ULTIMATELY ABLE TO "MASSAGE THE SYSTEM" ENOUGH TO GET THE STENT OUT OF THE SHEATH AND FULLY DEPLOYED IN THE CORRECT POSITION."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7536563 ↗
• InjuryNov 9, 2017Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  THIS FOLLOW UP REPORT IS BEING SUBMITTED BASED ON THE RECEIPT OF ADDITIONAL INFORMATION. ADDITION OF USER ERROR CODE TO EVALUATION CONCLUSION CODES. INITIAL REPORT DETAILS: AFTER DEPLOYMENT, THE STENT FORESHORTENED. AN ADDITIONAL STENT WAS PLACED AS A RESULT. 24-OCT-2017: THE FOLLOWING INFORMATION WAS RECEIVED AND UPDATED IN THE FILE. "THE DATE OF PROCEDURE WAS THE (B)(6). IT WAS A 6X80 ZILVER 635. LOT # C1191075. THE COMPLAINT WAS THAT IT FORESHORTENED TO APPROXIMATELY HALF OF ITS LENGTH, AND THAT BECAUSE OF THIS AN ADDITIONAL STENT HAD TO BE USED. THERE ARE ANGIOGRAPHIC IMAGES OF THE STENT POST DEPLOYMENT. IT LOOKS LIKE A CSI 014 VIPERWIRE WAS USED. THERE WAS CALCIFICATION, BUT THE ANATOMY WAS NOT TORTUOUS. THE STENT SYSTEM ADVANCED SMOOTHLY TO THE LESION. IT LOOKS LIKE THERE WAS SOME COMPRESSION ON THE STENT POST DEPLOYMENT AND A BALLOON WAS INTRODUCED TO FULLY EXPAND THE STENT. THE PHYSICIAN STATED THAT HE DID PULL HANDLE TOWARD THE HUB. WHETHER OR NOT THE PHYSICIAN PUSHED THE DELIVERY SYSTEM DURING DEPLOYMENT CANNOT BE CONFIRMED. "

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7013934 ↗
• MalfunctionMar 30, 2016Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  THE ZILVER STENT DEPLOYED PREMATURELY AND WAS DEPLOYED IN AN UNINTENDED LOCATION. THE SAFETY LOCK WAS STILL IN PLACE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5534077 ↗
• InjuryMar 23, 2016Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  USER COULD NOT FULLY DEPLOY THE ZILVER STENT. THE USER PREVIOUSLY FLUSHED BOTH LUMENS ON THE STENT SYSTEM. THE STENT WAS UNSHEATHED PARTIALLY AND THE DOCTOR DID THE PIN AND PULL. USER KEPT DOING THE PIN AND PULL (FOR A COUPLE OF SECONDS) AND FINALLY THE STENT DEPLOYED. NEXT DAY THE PATIENT HAD A STENT THROMBOSIS AND UNDERWENT A FEM/POP BYPASS.

  Patient problems: Thrombosis

  MAUDE report 5520371 ↗