Zilver PTX G24935Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10827002249353), received between Nov 14, 2016 and Feb 26, 2020 — classified as 8 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Occlusion Within Device” (6 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 26, 2020Fracture; Fracture

  (B)(4) STUDY PT, SITE REPORTED FRACTURE OF STUDY STENT ONE. TWO ZILVER® PTX® V STUDY STENTS WERE DEPLOYED DURING THE INDEX PROCEDURE ON (B)(6) 2014. THE STUDY LESION WAS THE LEFT DISTAL SFA. THE STUDY LESION WAS 120 MM LONG WITH 100% DIAMETER STENOSIS, MODERATE CALCIFICATION AND NO THROMBUS. THE PROXIMAL REFERENCE VESSEL DIAMETER (RVD) WAS 6.5 MM AND THE DISTAL RVD WAS 5.5 MM. THERE WAS ONE PATENT RUNOFF VESSEL. ENTRY SITE WAS CONTRALATERAL. PRE-STENT DILATATION WAS PERFORMED WITH ONE INFLATION OF A 5 MM X 140 MM BALLOON. THE TWO STUDY STENTS WERE DEPLOYED WITHOUT DIFFICULTY. POST-STENT DILATATION WAS PERFORMED WITH ONE INFLATION OF A 6 MM X 100 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. THE PATIENT WAS DISCHARGED ON (B)(6) 2014 (ONE DAY POST-PROCEDURE), TAKING ASPIRIN AND PLAVIX.. THE 12-MONTH X-RAY WAS NOT PERFORMED. ON (B)(6) 2019 (1890 DAYS POST-PROCEDURE), THE STUDY CLINICAL ASSESSMENT AND IMAGING WERE COMPLETED. PER THE SITE, STUDY STENT 1 HAD A TYPE 1 FRACTURE LOCATED IN THE MID-SECTION OF THE STENT. NO FRACTURE IS NOTED

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9755866 ↗
• MalfunctionNov 28, 2019Fracture; Fracture

  12-004 - STUDY PT, SITE REPORTED FRACTURE OF STUDY STENT ONE. TWO ZILVER® PTX® V STUDY STENTS WERE DEPLOYED DURING THE INDEX PROCEDURE ON (B)(6) 2014. THE STUDY LESION WAS THE LEFT DISTAL SFA. THE STUDY LESION WAS 120 MM LONG WITH 100% DIAMETER STENOSIS, MODERATE CALCIFICATION AND NO THROMBUS. THE PROXIMAL REFERENCE VESSEL DIAMETER (RVD) WAS 6.5 MM AND THE DISTAL RVD WAS 5.5 MM. THERE WAS ONE PATENT RUNOFF VESSEL. ENTRY SITE WAS CONTRALATERAL. PRE-STENT DILATATION WAS PERFORMED WITH ONE INFLATION OF A 5 MM X 140 MM BALLOON. THE TWO STUDY STENTS WERE DEPLOYED WITHOUT DIFFICULTY. POST-STENT DILATATION WAS PERFORMED WITH ONE INFLATION OF A 6 MM X 100 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. THE PATIENT WAS DISCHARGED ON (B)(6) 2014 (ONE DAY POST-PROCEDURE), TAKING ASPIRIN AND PLAVIX. THE 12-MONTH X-RAY WAS NOT PERFORMED. ON (B)(6) 2019 (1890 DAYS POST-PROCEDURE), THE STUDY CLINICAL ASSESSMENT AND IMAGING WERE COMPLETED. PER THE SITE, STUDY STENT 1 HAD A TYPE 1 FRACTURE LOCATED IN THE MID-SECTION OF THE STENT. NO FRACTURE IS NOTE

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9390230 ↗
• InjurySep 12, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  12-004 - STUDY PT, OCCLUSION/RESTENOSIS WITHIN STUDY STENTS, POSSIBLY RELATED TO STUDY PRODUCT AND PROCEDURE TWO ZILVER® PTX® V STUDY STENTS WERE DEPLOYED DURING THE INDEX PROCEDURE ON (B)(6) 2015. THE STUDY LESION WAS THE RIGHT DISTAL SFA AND POPLITEAL ARTERY. THE STUDY LESION WAS 120 MM LONG WITH 90% DIAMETER STENOSIS, MILD CALCIFICATION AND NO THROMBUS. THE PROXIMAL REFERENCE VESSEL DIAMETER (RVD) WAS 4.92 MM AND THE DISTAL RVD WAS 4.65 MM. THERE WERE THREE PATENT RUNOFF VESSELS. ENTRY SITE WAS CONTRALATERAL. PRE-STENT DILATATION WAS PERFORMED WITH ONE INFLATION OF A 5 MM X 40 MM BALLOON. POST-STENT DILATATION WAS PERFORMED WITH ONE INFLATION OF A 6 MM X 100 MM BALLOON. POST-STENT DILATATION WAS PERFORMED WITH TWO INFLATIONS OF A 6 MM X 100 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. THE PATIENT WAS DISCHARGED ON 09/08/2015 (FIVE DAYS POST-PROCEDURE), TAKING ASPIRIN AND PLAVIX. ON 17-MAR-2017 (561 DAYS POST-PROCEDURE), THE PATIENT EXPERIENCED AN OCCLUSION/RESTENOSIS OF THE STUDY LESION REQUIRING INTERVENTION. THE PATIENT CONT

  Patient problems: Occlusion

  MAUDE report 9009516 ↗
• InjurySep 9, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  ON (B)(6) 2019 (1356 DAYS POST-PROCEDURE), THE PATIENT WAS DIAGNOSED WITH AN OCCLUSION/RESTENOSIS WITHIN THE STUDY LESION REQUIRING INTERVENTION. TREATMENT INCLUDED BALLOON ANGIOPLASTY. THE PHYSICIAN INDICATED THE EVENT WAS POSSIBLY RELATED TO BOTH THE STUDY PRODUCT AND PROCEDURE. THE PRE-EXISTING CONDITION OF SYSTEMIC ATHEROSCLEROSIS CAUSED OR CONTRIBUTED TO THE EVENT. THE SITE HAS NOT COMPLETED THE SECONDARY INTERVENTION FORM, NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Occlusion; Stenosis

  MAUDE report 8974871 ↗
• InjuryDec 28, 2017Occlusion Within Device; Obstruction of Flow; Occlusion Within Device; Obstruction of Flow

  THIS FOLLOW UP REPORT IS BEING SUBMITTED BASED ON THE RECEIPT OF IMAGES RELATING TO THE PATIENT. INVESTIGATION IS STILL PENDING. A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS. (B)(6) OCCLUSION/RESTENOSIS OF THE STUDY LESION, RIGHT PROXIMAL SFA ON (B)(6) 2014 THE PATIENT RECEIVED TWO ZILVER PTX STUDY STENTS (6 MM X 100 MM; 6 MM X 80 MM) IN THE RIGHT PROXIMAL SFA. ON (B)(6) 2016 (734 DAYS POST-PROCEDURE), THE TWO-YEAR ULTRASOUND AND FOLLOW-UP ASSESSMENT WERE COMPLETED. THE ULTRASOUND REVEALED 50-99% STENOSIS PROXIMAL TO THE STUDY LESION AND PATENCY WITHIN AND DISTAL TO THE STUDY LESION. THE CORE LAB ANALYSIS REVEALED PATENCY PROXIMAL TO, WITHIN, AND DISTAL TO THE STUDY LESION. THE PATIENT COMPLAINED OF LIFESTYLE LIMITING CLAUDICATION WITH SYMPTOMS WORSENING THE LAST 2-3 MONTHS. THE RIGHT AND LEFT ABIS WERE 0.84 AND 0.9, RESPECTIVELY. RIGHT AND LEFT RUTHERFORD CLASSIFICATIONS WERE TWO AND ONE, RESPECTIVELY. THE PATIENT RETURNED FOR PERIPHERAL ANGIOGRAPHY ON (B)(6) 2016 (762 DAYS POST-PROCEDURE ¿ PREVIOUSLY REPORTED IN (B)(4)/ 3001845648-2016-00330 AND (B)(4) / 3001845648-2016-00331). ANGIOGRAPHY REVEALED 50-99% DIAMETER STENOSIS WITHIN THE STUDY LESION. PE

  Patient problems: Claudication; Reocclusion

  MAUDE report 7150477 ↗
• InjuryAug 11, 2017Occlusion Within Device; Occlusion Within Device

  THIS FOLLOW UP MDR IS BEING SUBMITTED DUE TO THE RECEIPT AND REVIEW OF IMAGES RELATING TO THIS EVENT. INITIAL REPORT DETAILS: (B)(6) ¿ WORSENED CLAUDICATION/REST PAIN DEFINITELY RELATED TO THE STUDY PRODUCT. ON (B)(6) 2015, THE PATIENT RECEIVED ONE 6 MM X 100 MM ZILVER PTX STUDY STENT IN THE LEFT PROXIMAL SFA. ON (B)(6) 2015, THE PATIENT UNDERWENT PRE-DILATATION OF STUDY LESION WITH ONE INFLATION OF A 5.0 MM X 40 MM BALLOON AT 10 SECONDS. ONE 6.0 MM X 100 MM (LOT # C1096737) WAS PLACED IN THE LEFT PROXIMAL SFA VIA CONTRALATERAL ACCESS. THE IMPLANTING PHYSICIAN NOTED THAT EASE OF DEVICE DEPLOYMENT WAS EASY. NO NON-STUDY STENTS WERE USED TO TREAT THE STUDY LESION. POST-STENT DILATATION WAS PERFORMED WITH TWO INFLATIONS OF A 6.0 MM X 100 MM DILATATION BALLOON FOR 52 SECONDS AT 8 ATM AND ONE INFLATION FOR 30 SECONDS AT 16 ATM. AT THE CONCLUSION OF THE CASE, NO THROMBUS OR DISSECTION WAS NOTED BY THE SITE, AND THE ENTIRE LENGTH OF THE STUDY STENT WAS APPOSED TO THE VESSEL WALL. THERE WAS NO RESIDUAL STENOSIS REMAINING IN THE STUDY LESION AND THE PROXIMAL AND DISTAL RVD WAS 5.0 MM AND 6.0 MM, RESPECTIVELY. THE POST-PROCEDURAL ABI WAS NOT PERFORMED FOR THE STUDY LEG. ON THE SAME DAY, THE

  Patient problems: Claudication; Occlusion

  MAUDE report 6787609 ↗
• InjuryAug 3, 2017Occlusion Within Device; Occlusion Within Device

  THIS INITIAL MDR IS BEING SUBMITTED TO CAPTURE A SECOND FAILURE MODE FROM THE IMAGE REVIEW [REFERENCE: MDR3001845648-2017-00255]. (B)(6) ¿ WORSENED CLAUDICATION/REST PAIN POSSIBLE RELATED TO STUDY PRODUCT . ON (B)(6) 2015, THE PATIENT RECEIVED ONE 6.0 MM X 100 MM ZILVER PTX STUDY STENT IN THE RIGHT DISTAL SFA. ON (B)(6) 2015, THE PATIENT UNDERWENT PRE-DILATATION OF STUDY LESION WITH ONE INFLATION OF A 5.0 MM X 80 MM BALLOON AT 8 SECONDS. ONE 6.0 MM X 100 MM (LOT # C1123550) WAS PLACED IN THE RIGHT DISTAL SFA VIA CONTRALATERAL ACCESS. THE IMPLANTING PHYSICIAN NOTED THAT EASE OF DEVICE DEPLOYMENT WAS EASY. NO NON-STUDY STENTS WERE USED TO TREAT THE STUDY LESION. POST-STENT DILATATION WAS PERFORMED WITH ONE INFLATION OF A 5.0 MM X 80 MM DILATATION BALLOON FOR 8 SECONDS. AT THE CONCLUSION OF THE CASE, NO THROMBUS OR DISSECTION WAS NOTED BY THE SITE, AND THE ENTIRE LENGTH OF THE STUDY STENT WAS APPOSED TO THE VESSEL WALL. THERE WAS NO RESIDUAL STENOSIS REMAINING IN THE STUDY LESION AND THE PROXIMAL AND DISTAL RVDS WERE 6.0 MM. THE POST-PROCEDURAL ABI WAS NOT PERFORMED FOR THE STUDY LEG. ON THE SAME DAY, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL TAKING PLAVIX AND ASPIRIN. ON (B)(6) 20

  Patient problems: Claudication; Occlusion

  MAUDE report 6763768 ↗
• InjuryJun 29, 2017Occlusion Within Device; Occlusion Within Device

  THIS FOLLOW UP MDR IS BEING SUBMITTED DUE TO IMAGE REVIEW (B)(6) PATIENT (B)(6) ¿ WORSENED CLAUDICATION/REST PAIN POSSIBLE RELATED TO STUDY PRODUCT. ON (B)(6) 2015, THE PATIENT RECEIVED ONE 6.0 MM X 100 MM ZILVER PTX STUDY STENT IN THE RIGHT DISTAL SFA. ON (B)(6) 2015, THE PATIENT UNDERWENT PRE-DILATATION OF STUDY LESION WITH ONE INFLATION OF A 5.0 MM X 80 MM BALLOON AT 8 SECONDS. ONE 6.0 MM X 100 MM (LOT # C1123550) WAS PLACED IN THE RIGHT DISTAL SFA VIA CONTRALATERAL ACCESS. THE IMPLANTING PHYSICIAN NOTED THAT EASE OF DEVICE DEPLOYMENT WAS EASY. NO NON-STUDY STENTS WERE USED TO TREAT THE STUDY LESION. POST-STENT DILATATION WAS PERFORMED WITH ONE INFLATION OF A 5.0 MM X 80 MM DILATATION BALLOON FOR 8 SECONDS. AT THE CONCLUSION OF THE CASE, NO THROMBUS OR DISSECTION WAS NOTED BY THE SITE, AND THE ENTIRE LENGTH OF THE STUDY STENT WAS APPOSED TO THE VESSEL WALL. THERE WAS NO RESIDUAL STENOSIS REMAINING IN THE STUDY LESION AND THE PROXIMAL AND DISTAL RVDS WERE 6.0 MM. THE POST-PROCEDURAL ABI WAS NOT PERFORMED FOR THE STUDY LEG. ON THE SAME DAY, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL TAKING PLAVIX AND ASPIRIN. ON (B)(6) 2016 (292 DAYS POST-PROCEDURE), THE PATIENT EXPERIENCED WORS

  Patient problems: Claudication; Occlusion

  MAUDE report 6677077 ↗
• InjuryNov 15, 2016Occlusion Within Device; Obstruction of Flow; Occlusion Within Device; Obstruction of Flow

  THIS FOLLOW UP MDR 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 PROXIMAL SFA ON (B)(6) 2014 THE PATIENT RECEIVED TWO ZILVER PTX STUDY STENTS (6 MM X 100 MM; 6 MM X 80 MM) IN THE RIGHT PROXIMAL SFA. ON (B)(6) 2016 (734 DAYS POST-PROCEDURE), THE TWO-YEAR ULTRASOUND AND FOLLOW-UP ASSESSMENT WERE COMPLETED. THE ULTRASOUND REVEALED 50-99% STENOSIS PROXIMAL TO THE STUDY LESION AND PATENCY WITHIN AND DISTAL TO THE STUDY LESION. THE CORE LAB ANALYSIS REVEALED PATENCY PROXIMAL TO, WITHIN, AND DISTAL TO THE STUDY LESION. THE PATIENT COMPLAINED OF LIFESTYLE LIMITING CLAUDICATION WITH SYMPTOMS WORSENING THE LAST 2-3 MONTHS. THE RIGHT AND LEFT ABIS WERE 0.84 AND 0.9, RESPECTIVELY. RIGHT AND LEFT RUTHERFORD CLASSIFICATIONS WERE TWO AND ONE, RESPECTIVELY. THE PATIENT RETURNED FOR PERIPHERAL ANGIOGRAPHY ON (B)(6) 2016 (762 DAYS POST-PROCEDURE). ANGIOGRAPHY REVEALED 50-99% DIAMETER STENOSIS WITHIN THE STUDY LESION. PERCUTANEOUS INTERVENTION INCLUDED BALLOON ANGIOPLASTY AND CUTTING BALLOON. INTERVENTION WAS CONSIDERED SUCCESSFUL WITH LESS THAN 50 % DIAMETER RESIDUAL STENOSIS REMAINING. PR

  Patient problems: Reocclusion

  MAUDE report 6102606 ↗
• InjuryNov 14, 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 DESCRIPTION WAS SUBMITTED AS FOLLOWS: (B)(6): WORSENED CLAUDICATION/REST PAIN (RIGHT). ON (B)(6) 2015 THE PATIENT RECEIVED ONE ZILVER PTX STUDY STENT (6 MM X 100 MM) IN THE RIGHT DISTAL SFA. ON (B)(6) 2016 (292 DAYS POST-PROCEDURE), THE PATIENT EXPERIENCED WORSENED CLAUDICATION/REST PAIN. THE RIGHT RUTHERFORD CLASSIFICATION WAS THREE AND THE PRE-INTERVENTION ANGIOGRAPHY REVEALED OCCLUSION OF THE STUDY LESION. THE INVESTIGATOR NOTED THE FOLLOWING: ¿NOT AMENABLE TO PERCUTANEOUS/ENDOVASCULAR INTERVENTION.¿ THE PATIENT UNDERWENT OPEN RIGHT FEM-POP ABOVE THE KNEE BYPASS USING VEIN GRAFT ON (B)(6) 2016 (336 DAYS POST-PROCEDURE). THE EVENT WAS CONSIDERED POSSIBLY RELATED TO THE STUDY PRODUCT AND NOT RELATED TO THE STUDY PROCEDURE. PRE-EXISTING PERIPHERAL VASCULAR DISEASE WAS ALSO NOTED TO HAVE CAUSED OR CONTRIBUTED TO THE EVENT. THE SITE MARKED NO TO THE QUESTION: DID THE DEVICE MALFUNCTION OR DETERIORATE IN CHARACTERISTICS OR PERFORMANCE?

  Patient problems: Pain; Reocclusion

  MAUDE report 6099075 ↗