Zilver PTX G24894Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10827002248943), received between Oct 18, 2016 and Jun 30, 2017 — classified as 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “Occlusion Within Device” (3 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 18, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryJun 30, 2017Occlusion Within Device; Occlusion Within Device

  THIS FOLLOW UP REPORT IS BEING SUBMITTED TO CANCEL THE INITIAL REPORT SENT IN RELATION TO THIS EVENT. INITIAL REPORTING WAS BASED ON THE SURGICAL INTERVENTION CARRIED OUT AS A RESULT OF THE OCCURRENCE OF OCCLUSION/RESTENOSIS WITHIN THE LESION WHERE A ZILVER PTX STENT WAS INDWELLING. ON RECEIPT OF THE IMAGE REVIEW FOR THIS COMPLAINT ON 19-JUL-2017 IT WAS CONFIRMED THAT NO RESTENOSIS WAS OBSERVED IN THE STUDY DEVICE. "THE ADDITIONAL COMPLAINT ADDS NO SIGNIFICANT TO CHALLENGE THE OBSERVATION THAT THE STENOSIS JUST PRIOR TO THE SECONDARY INTERVENTION WAS IN THE PRE-EXISTING NON-STUDY STENT AND NOT THE STUDY STENT.¿ CLARIFICATION IN RELATION TO THIS STATEMENT WAS REQUESTED FROM THE REVIEWER AND THE FOLLOWING COMMENT WAS PROVIDED: "BASED ON HOW THE PROVIDED IMAGING WAS LABELED, THE STENOSIS WAS NOT IN THE STUDY STENT BUT IN THE NON-STUDY STENT" THE MDR REPORTING DECISION HAS BEEN RE-ASSESSED AS NO LONGER MEETING THE FDA MDR REPORTING REQUIREMENTS AS THE IMAGE REVIEW CONFIRMED THAT THE SURGICAL INTERVENTION CARRIED OUT WAS NOT AS A RESULT OF THE RESTENOSIS WITHIN THE LESION WHERE A ZILVER PTX STENT WAS INDWELLING BUT WAS IN THE PRE-EXISTING NON-STUDY STENT. NO RESTENOSIS WAS OBSERVED IN T

  Patient problems: Reocclusion

  MAUDE report 6679987 ↗
• InjuryJan 19, 2017Device Damaged by Another Device; Difficult to Advance; Device Damaged by Another Device; Difficult to Advance

  A FOLLOW-UP MDR IS BEING SUBMITTED TO INCLUDE THE DEVICE EVALUATION DETAILS. INITIAL REPORT DETAILS: THEY SUCCESSFULLY DEPLOYED A 6 X 120 ZILVER PTX. THEY WENT TO ADD AN ADDITIONAL STENT. THEY TRIED TO ADVANCE THE STENT INTO THE 6 X 120 STENT TO OVERLAP THEM. THE END ON THE DELIVERY SYSTEM GOT CAUGHT ON THE EXISTING STENT AND BUCKLED THE ALREADY IMPLANTED STENT. THEY COULD NOT GET THE DELIVERY SYSTEM TO GO INSIDE OF THE OTHER STENT SO THE DELIVERY SYSTEM WAS REMOVED. HE THEN PUT A BALLOON IN AND ANGIOPLASTIED THE BUCKLED END OF THE ALREADY IMPLANTED STENT. HE ASKED FOR A NEW STENT. THE SAME THING HAPPENED WITH THE NEXT STENT. HE COULD NOT GET IT INSIDE OF THE PRE-EXISTING STENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A COMPETITIVE STENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6263623 ↗
• MalfunctionNov 17, 2016Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  (B)(4), PATIENT (B)(6): OCCLUSION/RESTENOSIS OF THE STUDY LESION, RIGHT PROXIMAL SFA. THE STENT WAS IMPLANTED IN COMPRESSION. THIS INFORMATION WAS RECEIVED IN AN IMAGE REVIEW RECEIVED RELATING TO REPORT # 3001845648-2016-00304.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6108962 ↗
• InjuryOct 27, 2016Occlusion Within Device; Occlusion Within Device

  (B)(6): OCCLUSION/RESTENOSIS OF THE STUDY LESION, RIGHT PROXIMAL SFA. ON (B)(6) 2014 THE PATIENT RECEIVED ONE ZILVER PTX STUDY STENT (7 MM X 60 MM) IN THE RIGHT PROXIMAL SFA. ON (B)(6) 2016 (785 DAYS POST-PROCEDURE), ULTRASOUND REVEALED 50-99% STENOSIS WITHIN THE STUDY LESION. ON THE SAME DAY THE PATIENT UNDERWENT PERCUTANEOUS BALLOON ANGIOPLASTY. THE PRE-INTERVENTION ABIS WERE 0.57 (RIGHT) AND 1.09 (LEFT). THE RIGHT RUTHERFORD CLASSIFICATION WAS THREE. PRE-INTERVENTION ANGIOGRAPHY HAS NOT BEEN PROVIDED. CORE LAB ANALYSIS IS NOT AVAILABLE. THE SECONDARY INTERVENTION WAS SUCCESSFUL WITH < 50% STENOSIS REMAINING. THE INVESTIGATOR NOTED THAT THE EVENT (OCCLUSION/RESTENOSIS) WAS PROBABLY RELATED TO THE STUDY PRODUCT AND UNLIKELY RELATED TO THE STUDY PROCEDURE. PRE-EXISTING PVD (PERIPHERAL VASCULAR DISEASE) WAS ALSO NOTED TO HAVE CAUSED OR CONTRIBUTED TO THE EVENT.

  Patient problems: Reocclusion

  MAUDE report 6059785 ↗
• InjuryOct 18, 2016Occlusion Within Device; Occlusion Within Device

  FOLLOWING ZILVER PTX STENT IMPLANTATION THE PATIENT RETURNED WITH A PAIN IN THEIR FOOT. PHYSICIAN TOOK ANGIO AND THE STENT WAS CONFIRMED TO BE THROMBOSED.

  Patient problems: Reocclusion

  MAUDE report 6036410 ↗