Zilver PTX G24895Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10827002248950), received between Jun 22, 2015 and Oct 7, 2016 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (1 report).

1 FDA recall record name this device's identifier.

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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Apr 18, 2013Terminated

   Cook Medical has received a small number of complaints related to the delivery system for the Zilver PTX Drug-Eluting Peripheral Stent involving fractures of the delivery system inner catheter after stent deployment, and separation of the inner catheter tip section (13 complaints with an occurrence rate of 0.043%) Two adverse events, including one death, occurred in cases where a tip separation

   Z-1275-2013 · Root cause: Process control · FDA record ↗

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryOct 7, 2016Occlusion Within Device; Occlusion Within Device

  THIS FOLLOW UP REPORT IS BEING SUBMITTED DUE TO THE RECEIPT AND REVIEW OF IMAGES. INITIAL DESCRIPTION SUBMITTED AS FOLLOWS: (B)(6): OCCLUSION/RESTENOSIS OF THE STUDY LESION, RIGHT SFA. ON (B)(6) 2015 THE PATIENT RECEIVED ONE ZILVER PTX STUDY STENT (7 MM X 80 MM) IN THE RIGHT DISTAL SFA. ON (B)(6) 2016 (377 DAYS POST-PROCEDURE), THE PATIENT EXPERIENCED WORSENED CLAUDICATION OF THE RIGHT LOWER EXTREMITY THAT THE INVESTIGATOR CONSIDERED UNLIKELY RELATED TO THE STUDY DEVICE. THE PATIENT WAS TREATED WITH A CHANGE OF MEDICATIONS. ON (B)(6) 2016 (458 DAYS POST-PROCEDURE), THE PATIENT UNDERWENT RE-INTERVENTION DUE TO OCCLUSION/RESTENOSIS WITHIN THE STUDY LESION (RIGHT SFA). SYMPTOMS INCLUDED WORSENING CLAUDICATION. THE RIGHT RUTHERFORD CLASSIFICATION WAS THREE. PRE-INTERVENTION ANGIOGRAPHY REVEALED 50-99% STENOSIS WITHIN THE STUDY LESION. CORE LAB ANALYSIS OF THE ANGIOGRAPHY IS NOT YET AVAILABLE. INTERVENTION INCLUDED PERCUTANEOUS ATHERECTOMY, BALLOON ANGIOPLASTY AND THROMBECTOMY. THE EVENT (OCCLUSION/RESTENOSIS) WAS CONSIDERED POSSIBLY RELATED TO BOTH THE STUDY PRODUCT AND STUDY PROCEDURE. PRE-EXISTING PERIPHERAL VASCULAR DISEASE WAS ALSO NOTED TO HAVE CAUSED OR CONTRIBUTED TO THE EVENT.

  Patient problems: Reocclusion

  MAUDE report 6010546 ↗
• MalfunctionAug 29, 2016Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  AS REPORTED TO CUSTOMER RELATIONS: "THE DOCTOR MENTIONED THAT THE ZILVER PTX STENTS SHORTENED, HE PLACED A 6.0..X 80MM PTA BALLOON, IT SHOWS THE SHORTENING. OTHER THAN THE SHORTENING THE RESULTS TURNED OUT WELL." TWO ZILVER PTX STENTS OF DIFFERENT LOTS ARE REPORTED TO BE INVOLVED IN THIS EVENT. REFERENCE ALSO REPORT # 3001845648-2016-00229.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5909809 ↗
• InjuryJun 22, 2015Device Operates Differently Than Expected

  ON (B)(6) 2015 THE PATIENT WAS DIAGNOSED WITH A THROMBUS IN THE RIGHT SFA WITHIN THE STUDY LESION. THE THROMBUS WAS IDENTIFIED VIA ANGIOGRAPHY AND THE ANGIOGRAPHIC APPEARANCE WAS HIGHLY SUGGESTIVE OF THROMBUS. THE PATIENT HAD EXPERIENCED RAPID ONSET OF CLINICAL SIGNS AND SYMPTOMS. TREATMENT INCLUDED THROMBECTOMY AND THROMBOLYSIS. THE PHYSICIAN INDICATED THAT THE EVENT WAS THOUGHT TO POSSIBLY BE RELATED TO THE STUDY PRODUCT AND THAT THE PRE-EXISTING CONDITION OF PERIPHERAL VASCULAR DISEASE CAUSED OR CONTRIBUTED TO THE EVENT. THE PATIENT WAS HOSPITALIZED FOR THE EVENT. THE EVENT END DATE WAS NOTED TO BE (B)(6) 2015.

  Patient problems: Surgical procedure, additional; Thrombosis

  MAUDE report 4870761 ↗