Zilver PTX G24889Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10827002248899), received between Apr 14, 2016 and May 8, 2019 — classified as 1 injury, 1 malfunction.

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

• InjuryMay 8, 2019Obstruction of Flow; Adverse Event Without Identified Device or Use Problem; Obstruction of Flow; Adverse Event Without Identified Device or Use Problem

  THIS REPORT IS BEING SUBMITTED BASED ON THE NEED FOR INTERVENTION (BALLOON ANGIOPLASTY). TWO ZILVER® PTX® V STUDY STENTS WERE PLACED. THE FIRST, 6 MM X 80 MM AND THE SECOND, 6 MM X 60 MM ON (B)(6) 2015 THE PATIENT RECEIVED TWO STUDY STENTS IN THE LEFT PROXIMAL SFA. THE STUDY LESION WAS 40 MM LONG WITH 80% DIAMETER STENOSIS, SEVERE CALCIFICATION AND NO THROMBUS. PRE-STENT DILATATION WAS PERFORMED WITH ONE INFLATION OF A 5 MM X 150 MM BALLOON. POST-STENT DILATATION WAS PERFORMED WITH ONE INFLATION OF A 6 MM X 60 MM BALLOON. FINAL ANGIOGRAPHY MEASUREMENTS REVEALED 0 % RESIDUAL STENOSIS IN THE STUDY LESION. THERE WAS NO THROMBUS OR DISSECTION AND THE ENTIRE LENGTH OF THE STENTS WERE APPOSED TO THE VESSEL WALL. ON (B)(6) 2019 THE 4-YEAR FOLLOW-UP ASSESSMENT AND ULTRASOUND WERE COMPLETED. THE ULTRASOUND REVEALED 50-99% STENOSIS WITHIN THE STUDY STENT. LEFT ABI MEASURED 0.95 AND LEFT RUTHERFORD CLASSIFICATION WAS TWO. ON (B)(6) 2019 (1421 DAYS POST-PROCEDURE), THE PATIENT COMPLAINED OF WORSENED CLAUDICATION/REST PAIN. ON THE SAME DAY THE PATIENT UNDERWENT PERCUTANEOUS BALLOON DILATION (IDENTIFIED ON THE CASE REPORT FORM AS STENT 1). THE PROCEDURE REPORT IDENTIFIED IN-STENT STENOSIS OF THE

  Patient problems: Pain

  MAUDE report 8591154 ↗
• MalfunctionApr 14, 2016Fracture; Activation, Positioning or Separation Problem; Fracture; Activation, Positioning or Separation Problem

  DURING AN SFA ZILVER PTX STENTING AND ANGIOPLASTY PROCEDURE, THE PHYSICIAN DEPLOYED THE ZILVER PTX 6X60 AND THE PHYSICIAN FELT A LOT OF RESISTANCE. DURING THE MIDDLE OF THE DEPLOYMENT, INSTEAD OF UNSHEATHING THE STENT, THE STENT SHRANK AND WAS DEPLOYED TO THE FINAL LENGTH OF 4.5CM. THE PHYSICIAN TOLD THE DISTRICT MANAGER THAT IT COULD BE THE DISTAL PUSHER RING OF THE ZILVER SHEATH THAT PUSHED THE DISTAL PART OF THE STENT OR COULD BE A STENT FRACTURE. TO SOLVE THE ISSUE THE PHYSICIAN PUT ANOTHER STENT INSIDE THE COMPLAINT STENT. NO HARM TO THE PATIENT AND NO ADDITIONAL PROCEDURES WERE REQUIRED DUE TO THIS OCCURRENCE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5576016 ↗