Zilver PTX G24937Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10827002249377), received between Apr 20, 2016 and Oct 12, 2016 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Occlusion Within Device” (2 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 16, 2026.

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.

• MalfunctionOct 12, 2016Device Expiration Issue; Device Expiration Issue

  THIS FOLLOW UP REPORT IS BEING SUBMITTED WITH THE INVESTIGATION CONCLUSIONS. AN EXPIRED ZILVER STENT WAS IMPLANTED IN A PATIENT. THE CUSTOMER HAS EXPERIENCED NO ADVERSE EFFECTS.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 6019832 ↗
• InjuryJul 14, 2016Occlusion Within Device; Occlusion Within Device

  THIS FOLLOW UP REPORT IS BEING SUBMITTED DUE TO THE RECEIPT OF IMAGES RELATING TO THIS EVENT AND THE SUBSEQUENT REVIEW OF THESE IMAGES. RELATED TO THE FOLLOWING REPORTS: 3001845648-2016-00193 & 3001845648-2016-00181 (THIRD INTERVENTION); 3001845648-2015-00250 & 3001845648-2015-00251 (SECOND INTERVENTION). INITIAL DESCRIPTION SUBMITTED AS FOLLOWS: PROTOCOL 12-004, PT. (B)(6), THROMBOSIS OF THE STUDY LESION PROBABLY RELATED TO THE STUDY PRODUCT. ON (B)(6) 2014, THE LESION WAS PRE-DILATED WITH ONE INFLATION OF A 4 MM X 140 MM BALLOON AT 10 ATM FOR 30 SECONDS. ONE 6 MM X 80 MM AND ONE 7 MM X 100 MM ZILVER® PTX® V STUDY STENTS (LOT # C994205/C1003485) WERE PLACED IN THE LEFT DISTAL SFA VIA CONTRALATERAL ACCESS. THE IMPLANTING PHYSICIAN NOTED THAT EASE OF DEVICE DEPLOYMENT WAS VERY EASY. NO NON-STUDY STENTS WERE USED TO TREAT THE STUDY LESION. POST-STENT DILATATION WAS PERFORMED WITH ONE INFLATION OF A 6 MM X 140 MM BALLOON AT 10 ATM FOR 30 SECONDS, ONE INFLATION OF A 7 MM X 60 MM BALLOON AT 10 ATM FOR 30 SECONDS, AND ONE INFLATION OF A 10 MM X 60 MM BALLOON AT 10 ATM FOR 30 SECONDS. AT THE CONCLUSION OF THE CASE, NO THROMBUS OR DISSECTION WAS NOTED BY THE SITE, THE ENTIRE LENGTH OF THE

  Patient problems: Reocclusion

  MAUDE report 5794270 ↗
• InjuryApr 20, 2016Occlusion Within Device; Occlusion Within Device

  THIS FOLLOW UP REPORT IS BEING SUBMITTED DUE TO THE RECEIPT AND REVIEW OF IMAGES RELATING TO THIS EVENT. INITIAL EVENT DESCRIPTION SUBMITTED AS FOLLOWS: (B)(4), PT (B)(6), OCCLUSION/RESTENOSIS OF THE STUDY LESION REQUIRING INTERVENTION DEFINITELY RELATED TO THE STUDY PRODUCT. THE LESION MORPHOLOGY REVEALED A TASC II, TYPE A LESION WITH MILD CALCIFICATION AND NO THROMBUS. THERE WAS NO PREVIOUS INTERVENTION IN THE STUDY LESION. THERE WAS NO INFLOW TRACT STENOSIS GREATER THAN 50% AND THERE WAS ONE PATENT RUNOFF VESSEL. BASELINE ANGIOGRAPHIC LESION MEASUREMENTS REVEALED A PROXIMAL REFERENCE VESSEL DIAMETER (RVD) OF 6.0 MM, A DISTAL RVD OF 5.5 MM, AND A 90% DIAMETER STENOSIS IN THE STUDY LESION. THE LESION LENGTH WAS 80.0 MM. THE RIGHT ABI WAS 0.95 AND THE LEFT ABI WAS 0.68. THE RIGHT AND LEFT RUTHERFORD CLASSIFICATIONS WERE THREE. ON (B)(6) 2015, THE PATIENT UNDERWENT PRE-DILATATION OF STUDY LESION WITH ONE INFLATION OF A 5.0 X 40 MM BALLOON AT 6 ATM FOR 65 SECONDS. ONE 7.0 MM X 40 MM (LOT # C1039561) ZILVER PTX V STUDY STENT WAS PLACED IN THE LEFT DISTAL SUPERFICIAL FEMORAL ARTERY VIA CONTRALATERAL ACCESS. THE IMPLANTING PHYSICIAN NOTED THAT EASE OF DEVICE DEPLOYMENT WAS EASY. NO NON-

  Patient problems: Reocclusion

  MAUDE report 5589943 ↗