Zilver PTX G38415Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10827002384153), received between Mar 11, 2021 and May 14, 2024 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 14, 2024Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  PER REP - 06DEC2023 - THE PRODUCT WAS FLUSHED AND PREPPED ACCORDING TO THE IFU. WHEN THE PHYSICIAN TRIED TO PUT THE DEVICE IN OVER THE WIRE THE PRODUCT WOULD ONLY GO SO FAR. DEVICE APPEARED TO BE ¿CRIMPED¿. PER REP - 09DEC2023 - IT NEVER TOUCHED THE BODY. PATIENT/EVENT INFO - NOTES: PREFIX ZIV6-PTX/ZISV6-PTX 3.60 ARE IMAGES (E.G. ANGIOGRAPHY, US ETC.) OF THE DEVICE AND/OR PROCEDURE AVAILABLE? NO 3.61 WAS THE DEVICE FLUSHED BEFORE THE PROCEDURE, AS PER IFU? YES 3.62 WERE THERE ANY ISSUES WITH FLUSHING OF THE DEVICE? NO 3.63 DETAILS OF THE ACCESS SHEATH USED (NAME, FR SIZE,LENGTH)? 6F TERUMO SHORT SHEATH 3.64 DETAILS OF THE WIRE GUIDE USED (NAME, DIAMETER, HYRDOPHYLLIC)? UNSURE OF THE WIRE EXCEPT THAT IT WAS AN 018. 3.65 WHAT APPROACH WAS USED TO ACCESS THE TARGET SITE? RETROGRADE IPSALATERAL ¿ PLEASE SPECIFY FOR OTHER: ¿ IF CONTRALATERAL, WAS THE BIFURCATION ANGLE STEEP? N/A, YES, NO 3.66 WHAT WAS THE TARGET LOCATION FOR THE STENT? SFA 3.67 WHAT ARTERY WAS THE STENT PLACED IN? IT WAS NOT PLACED AT ALL ¿ PLEASE SPECIFY FOR OTHER: 3.68 WAS THE WIRE GUIDE REMOVED FROM THE PATIENT PRIOR TO ADVANCING THE DELIVERY SYSTEM? THE WIRE WOULD NOT GO THROUGH THE STENT. THE STENT OR DELIVERY SYST

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19309166 ↗
• MalfunctionMar 11, 2021Break; Structural Problem; Break; Structural Problem

  THIS IS A SUPPLEMENTAL REPORT BEING SUBMITTED FOR THE RETURN OF DEVICE AND LAB EVALUATION COMPLETED ON 19-MAR-21. THE INVESTIGATION IS STILL ON GOING. AS INITIALLY REPORTED TO CUSTOMER RELATIONS VIA PHONE CONVERSATION WITH DISTRICT MANAGER: A PATIENT OF UNDISCLOSED AGE AND GENDER UNDERWENT A FEMORAL POPLITEAL STENTING PROCEDURE IN WHICH THE ZILVER PTX 35 DRUG-ELUTING STENT, (B)(6), WAS USED. THE PHYSICIAN WENT TO DEPLOY THE STENT AND UPON DEPLOYMENT THE THUMB-WHEEL BROKE AND HAD TO BREAK THE CASING TO HAND DEPLOY. THE STENT GOT STUCK AND ONLY PARTIALLY DEPLOYED. THE PHYSICIAN WAS ABLE TO RETRACT THE STENT INTO THE SHEATH AND REMOVE THE DEVICE. ANOTHER OF THE SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE. PATIENT OUTCOME: 1. DID ANY UNINTENDED SECTION OF THE DEVICE REMAIN INSIDE THE PATIENT¿S BODY? NO. IF YES, PLEASE DESCRIBE. 2. WAS THE PATIENT HOSPITALIZED OR WAS THERE PROLONGED HOSPITALIZATION? NO. 3. DID THE PATIENT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE? NO. IF YES, PLEASE DESCRIBE. 4. DID THE PRODUCT CAUSE OR CONTRIBUTE TO THE NEED FOR ADDITIONAL PROCEDURES? NO. IF YES, PLEASE SPECIFY ADDITIONAL PROCEDURES AND PROVIDE DETAILS. 5. HAS THE COMPLAINANT REPORTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11463720 ↗