Zilver PTX G38487Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10827002384870), received between May 29, 2017 and Mar 26, 2025 — classified as 1 injury, 5 malfunctions.

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

• InjuryMar 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE INITIAL REPORTER: ON THURSDAY AFTERNOON (2/27) DURING ANGIO AND LOWER EXTREMITY INTERVENTION, THE PHYSICIAN DEPLOYED FOUR ZILVER PTX STENTS IN AN SFA (TWO 7X140 PTX STENTS G38491 AND ONE 7X60 STENT G38487 IN PROXIMAL SFA ALONG WITH ONE 6X140 PTX STENT G38483) IN DISTAL SFA. AFTER POST DILATING WITH A 5X220 MUSTANG BALLOON, DR WAS PLEASED WITH THE FINAL RUN IMAGING (SEE ATTACHED). HOWEVER, SHE LET US KNOW YESTERDAY AFTERNOON THAT THE PATIENT THROMBOSED, POSSIBLY WITHIN THE STENTED SEGMENT. DR SAID IT¿S STRANGE THAT THE STENTS THROMBOSED BECAUSE HER REST PAIN WAS HEALED, AND SHE FEELS A LOT BETTER. THEY LOADED PLAVIX IN RECOVERY, AND SHE HAD BEEN ON ASA PRIOR TO THE CASE, SO THERE WAS NO LAPSE IN ANTI-PLATELET THERAPY. THEY JUST GOT A DUPLEX ULTRASOUND IN FOLLOW UP SO SHE¿S BRINGING THE PATIENT IN LATER TODAY FOR EITHER THROMBECTOMY OR BYPASS, BASED ON WHAT IS FOUND UNDER FLUORO. SHE BELIEVES THE LONG-STENTED SEGMENT, COMBINED WITH UNTREATED HYPOTENSION COULD BE THE SOURCE OF THE THROMBOSIS. SHE ALSO EXPRESSED CONCERNS OVER POTENTIAL FOR THUMBWHEEL DEPLOYMENT STENTS TO JUMP AND PREFERS PIN-AND-PULL FOR MORE PRECISION. THE PATIENT THROMBOSED, POSSIBLY WITHIN THE STENT

  Patient problems: Thrombosis/Thrombus

  MAUDE report 21701863 ↗
• MalfunctionDec 15, 2023Off-Label Use; Off-Label Use

  THE INTENDED TARGET SITE FOR THE DEVICE WAS THE RIGHT COMMON ILIAC; HOWEVER, THE DEVICE LANDED FURTHER UP INTO THE AORTA AS THE USER BELIEVED IT WAS NOT WELL IMPOSED. THE USER WANTED TO USE A CUFF TO RECTIFY BUT THE STENT WAS VERY MOBILE SO THEY ELECTED TO LEAVE IT ALONE. IT APPEARED IT WOULD MIGRATE NORTH TOWARD THE RENAL SO THEY ELECTED TO NOT INTERVENE. IT IS IMPORTANT TO NOTE THE DEVICE WAS BEING USED OFF LABEL. PATIENT OUTCOME: NA. PATIENT/EVENT INFO - NOTES: SHEATH USED . WIRE GUIDE. IPSILATERAL . RIGHT COM ILIAC - OFF LABEL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18335069 ↗
• MalfunctionSep 13, 2022Break; Material Deformation; Activation Failure; Break; Material Deformation; Activation Failure

  AS INITIALLY REPORTED TO CUSTOMER RELATIONS: A PATIENT OF UNSPECIFIED GENDER AND AGE UNDERWENT AN UNSPECIFIED PROCEDURE IN WHICH THE ZILVER PTX STENT WAS USED. THE PTX STENT DIDN'T DEPLOY CORRECTLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15409488 ↗
• MalfunctionApr 2, 2020Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  AS INITIALLY REPORTED TO CUSTOMER RELATIONS VIA PHONE DISCUSSION WITH THE DISTRICT MANAGER: A (B)(6) PATIENT, WHO PREVIOUSLY HAD A ZILVER PTX STENT PLACED, UNDERWENT A LEFT SFA PROCEDURE IN WHICH A ZILVER PTX 35 DRUG-ELUTING STENT, G38487, WAS TO BE PLACED TO EXTEND BELOW THE PREVIOUS STENT AS THE DISEASE HAD SPREAD. THE PHYSICIAN STARTED TO DEPLOY THE STENT AND IT GOT STUCK HALF WAY THROUGH DEPLOYMENT; THE THUMB WHEEL DID NOT MOVE. PHYSICIAN THEN TRIED THE RED BUTTON BUT THE STENT WOULD NOT MOVE; PUSHED ON THE THUMB WHEEL FIRMLY AND IT JUMPED AND THE REST OF THE STENT DEPLOYED. PER PHYSICIAN CONFIRMATION THE STENT HAD DEPLOYED IN TARGETED LOCATION WELL ENOUGH. AN ADDITIONAL THREE (3) OF THE SAME ZILVER STENTS, G38487, WERE DEPLOYED TO COVER THE DISEASED PART THAT HAD SPREAD AND THESE STENTS DEPLOYED WITH NO DIFFICULTY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9917091 ↗
• MalfunctionOct 24, 2019Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  REPORTED BY THE DM VIA PHONE CALL- DURING THE PROCEDURE BOTH STENTS DID NOT DEPLOY EVENLY. THEY DEPLOYED FULLY, BUT WERE CRUNCHED UP. BOTH STENTS ARE IMPLANTED IN THE PATIENT. FDA MDR REPORTING REQUIRED: EVENT IS FDA MDR REPORTABLE BASED ON THE DEVICE MALFUNCTION REPORTING PRECEDENCE FOR THIS DEVICE FAMILY FOR THE ISSUE OF 'STENT SHORTENING OR COMPRESSION DURING DEPLOYMENT' . NO ADVERSE EFFECTS TO THE PATIENT HAVE BEEN REPORTED AS OCCURRING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9231449 ↗
• MalfunctionMay 29, 2017Device Expiration Issue; Device Expiration Issue

  AFTER IMPLANTING THE STENT, THE CUSTOMER REALIZED THAT THE DEVICE HAD EXPIRED. THE REP WAS NOT PRESENT DURING THE SELECTION OF THIS DEVICE OR DURING DEPLOYMENT. THE STENT WAS PLACED SUCCESSFULLY AND NO PROBLEMS WERE OBSERVED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6596478 ↗