Zilver PTX G24890Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 10827002248905), received between Oct 30, 2014 and Oct 10, 2019 — classified as 18 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Occlusion Within Device” (11 reports).

1 FDA recall record name this device's identifier.

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.

Recalls naming this device

1. Apr 18, 2013Terminated

   Cook Medical has received a small number of complaints related to the delivery system for the Zilver PTX Drug-Eluting Peripheral Stent involving fractures of the delivery system inner catheter after stent deployment, and separation of the inner catheter tip section (13 complaints with an occurrence rate of 0.043%) Two adverse events, including one death, occurred in cases where a tip separation

   Z-1274-2013 · Root cause: Process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 10, 2019Fracture; Fracture

  12-004, PATIENT: (B)(6): STENT FRACTURE (CORE LAB REPORTED). 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, (762 DAYS POST-PROCEDURE ¿ PREVIOUSLY REPORTED IN PR#: (B)(4). ANGIOGRAPHY REVEALED 50-99% DIAMETER STENOSIS WITHIN THE STUDY LESION. SUCCESSFUL PERCUTANEOUS INTERVENTION INCLUDED BALLOON ANGIOPLASTY AND CUTTING BALLOON. ON (B)(6) 2017, (1175 DAYS POST-PROCEDURE ¿ PREVIOUSLY REPORTED AS PR#: (B)(4). PRE-INTERVENTION ANGIOGRAPHY REVEALED 50-99% STENOSIS IN THE STUDY LESION. SUCCESSFUL PERCUTANEOUS INTERVENTION INCLUDED A BALLOON ANGIOPLASTY WITH A DRUG COATED BALLOON. ON (B)(6) 2019 (1748 DAYS POST-PROCEDURE), AN X-RAY WAS COMPLETED AND THE SITE IDENTIFIED NO STENT FRACTURES IN EITHER STUDY STENT 1 OR 2. CORE LAB REVIEW OF THE IMAGING IDENTIFIED A TYPE 1 FRACTURE IN STUDY STENT #2. THERE WERE NO FRACTURES IDENTIFIED IN STUDY STENT 1. FDA MDR REPORTING REQUIRED: EVENT IS FDA MDR REPORTABLE BASED ON THE DEVICE MALFUNCTION REPORTING PRECEDENCE FOR THIS DEVICE FAMILY FOR THE ISSUE OF ¿STENT FRACTURE'. NO ADVERSE EFFECTS TO THE PATIENT HAVE BEEN REPORTED AS OCCURRING. THIS COMPLAINT REPORT DO

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9174687 ↗
• 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). 12-004, STUDY PT (B)(6), WORSENED CLAUDICATION/REST PAIN, POSSIBLY RELATED TO STUDY PRODUCT. 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

  Patient problems: Pain

  MAUDE report 8591119 ↗
• InjuryJun 26, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2018, THE PATIENT WAS DIAGNOSED WITH AN OCCLUSION/RESTENOSIS IN THE LEFT DISTAL SFA WITHIN THE STUDY LESION. TREATMENT INCLUDED BALLOON ANGIOPLASTY AND STENT PLACEMENT. THE PHYSICIAN INDICATED THAT THE EVENT WAS THOUGHT TO BE POSSIBLY RELATED TO THE STUDY PRODUCT AND PROCEDURE. THE PRE-EXISTING CONDITION OF PERIPHERAL VASCULAR DISEASE CAUSED OR CONTRIBUTED TO THIS EVENT. IT IS UNKNOWN IF IMAGING IS AVAILABLE. SAME PATIENT ALSO REPORTED IN REPORT # 3001845648-2015-00120.

  Patient problems: Occlusion

  MAUDE report 7637697 ↗
• InjuryApr 17, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS FOLLOW UP REPORT IS BEING SUBMITTED TO UPDATE THE INVESTIGATION RESULTS. INITIAL MDR REQUIRED BASED ON THE REQUIREMENT FOR A SURGICAL INTERVENTION (INTERVENTION INCLUDED BALLOON ANGIOPLASTY, STENT PLACEMENT, AND A FEMORAL ENDARTERECTOMY.) 12-004 PATIENT (B)(6): OCCLUSION/RESTENOSIS OF THE STUDY LESION, RIGHT SFA. ON (B)(6) 2014, THE PATIENT RECEIVED ONE ZILVER PTX STUDY STENT (6 MM X 80 MM) IN THE RIGHT DISTAL SFA. ON (B)(6) 2017, THE PATIENT REPORTED WORSENING CLAUDICATION OF THE RIGHT LOWER EXTREMITY. AN ULTRASOUND WAS PERFORMED AND REVEALED STENOSIS WITHIN THE STUDY STENT. ON (B)(6) 2018, THE PATIENT HAD A CTA OF THE RIGHT LEG WHICH REVEALED STENOSIS WITHIN THE STUDY STENT. ON (B)(6) 2018, THE PATIENT UNDERWENT RE-INTERVENTION DUE TO THE OCCLUSION/RESTENOSIS WITHIN THE STUDY LESION (RIGHT SFA). SYMPTOMS INCLUDED WORSENING CLAUDICATION. THE RIGHT RUTHERFORD CLASSIFICATION WAS TWO. PRE-INTERVENTION ANGIOGRAPHY REVEALED 50-99% STENOSIS WITHIN THE STUDY LESION. INTERVENTION INCLUDED BALLOON ANGIOPLASTY, STENT PLACEMENT, AND A FEMORAL ENDARTERECTOMY. CORE LAB ANALYSIS OF THE ANGIOGRAPHY IS NOT YET AVAILABLE. THE EVENT (OCCLUSION/RESTENOSIS) WAS CONSIDERED DEFINITELY RELATED TO T

  Patient problems: Occlusion; Stenosis

  MAUDE report 7435473 ↗
• InjuryFeb 1, 2018Kinked; Kinked

  STENT WAS SUBJECT TO KINKING AS A RESULT OF KNEE FLEXING. (B)(4) PATIENT (B)(6) ¿ OCCLUSION/RESTENOSIS DEFINITELY RELATED TO STUDY PRODUCT AT THE INDEX PROCEDURE ON (B)(6) 2014, THE PATIENT RECEIVED ONE 6 MM X 80 MM ZILVER PTX STUDY STENT IN THE RIGHT POPLITEAL ARTERY. ON (B)(6) 2014, THE PATIENT UNDERWENT PRE-DILATATION OF STUDY LESION WITH ONE INFLATION OF A 5.0 X 80 MM BALLOON AT 6 ATM FOR 45 SECONDS AND A SECOND INFLATION AT 5 ATM FOR 60 SECONDS. ONE 6.0 MM X 80 MM STUDY STENT (LOT # C950186) WAS PLACED IN THE POPLITEAL ARTERY VIA CONTRALATERAL ACCESS. THE IMPLANTING PHYSICIAN NOTED THAT 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 5.0 MM X 80 MM BALLOON AT 4 ATM FOR 15 SECONDS AND 10 ATM FOR 10 SECONDS. AT THE CONCLUSION OF THE CASE, THROMBUS WAS PRESENT AND WAS TREATED. THERE WAS NO DISSECTION NOTED BY THE SITE, AND THE ENTIRE LENGTH OF THE STUDY STENT WAS APPOSED TO THE VESSEL WALL. THERE WAS 10% RESIDUAL STENOSIS REMAINING IN THE STUDY LESION. THE PROXIMAL AND DISTAL RVDS WERE 5.0 MM. THE POST-PROCEDURAL ABI WAS 0.93 FOR THE STUDY LEG. ON THE SAME DAY, THE PATIENT WAS DISCHA

  Patient problems: Occlusion

  MAUDE report 7234101 ↗
• InjuryJan 15, 2018Occlusion Within Device; Occlusion Within Device

  OCCLUSION/RESTENOSIS DEFINITELY RELATED TO STUDY PRODUCT. AT THE INDEX PROCEDURE ON (B)(6) 2014, THE PATIENT RECEIVED ONE 6 MM X 80 MM ZILVER PTX STUDY STENT IN THE RIGHT POPLITEAL ARTERY. ON (B)(6) 2014, THE PATIENT UNDERWENT PRE-DILATATION OF STUDY LESION WITH ONE INFLATION OF A 5.0 X 80 MM BALLOON AT 6 ATM FOR 45 SECONDS AND A SECOND INFLATION AT 5 ATM FOR 60 SECONDS. ONE 6.0 MM X 80 MM STUDY STENT WAS PLACED IN THE POPLITEAL ARTERY VIA CONTRALATERAL ACCESS. THE IMPLANTING PHYSICIAN NOTED THAT 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 5.0 MM X 80 MM BALLOON AT 4 ATM FOR 15 SECONDS AND 10 ATM FOR 10 SECONDS. AT THE CONCLUSION OF THE CASE, THROMBUS WAS PRESENT AND WAS TREATED. THERE WAS NO DISSECTION NOTED BY THE SITE, AND THE ENTIRE LENGTH OF THE STUDY STENT WAS APPOSED TO THE VESSEL WALL. THERE WAS 10 % RESIDUAL STENOSIS REMAINING IN THE STUDY LESION. THE PROXIMAL AND DISTAL RVDS WERE 5.0 MM. THE POST-PROCEDURAL ABI WAS 0.93 FOR THE STUDY LEG. ON THE SAME DAY, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL TAKING ASPIRIN AND PLAVIX. ON (B)(6) 2017 (1433 DAYS POST-PROCEDURE), THE

  Patient problems: Reocclusion

  MAUDE report 7189303 ↗
• 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). ANGIOGRAPHY REVEALED 50-99% DIAMETER STENOSIS WITHIN THE STUDY LESION. PERCUTANEOUS INTERVENTION INCLUDED BALLOON ANGIOPLASTY AND CU

  Patient problems: Claudication; Reocclusion

  MAUDE report 7150478 ↗
• MalfunctionSep 12, 2017Fracture; Fracture

  THIS FOLLOW UP MDR IS BEING SUBMITTED DUE TO THE RECEIPT AND REVIEW OF IMAGES RELATING TO THIS EVENT. INITIAL REPORT DETAILS: (B)(6)  STENT FRACTURE. ON (B)(6) 2014, THE PATIENT RECEIVED TWO 6 MM X 80 MM ZILVER PTX STUDY STENTS IN THE RIGHT DISTAL SFA. THE PATIENT UNDERWENT PRE-DILATATION OF THE STUDY LESION WITH TWO INFLATIONS OF A 5.0 MM X 300 MM BALLOON AT 14 ATM FOR 120 SECONDS. TWO 6.0 MM X 80 MM (LOT #S C970391) WERE PLACED OVERLAPPING ONE ANOTHER IN THE RIGHT DISTAL SFA VIA CONTRALATERAL ACCESS. THE IMPLANTING PHYSICIAN NOTED THAT FOR EACH STENT 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 6.0 MM X 300 MM BALLOON AT 10 ATM FOR 120 SECONDS, AND ONE INFLATION OF A 6.0 MM X 80 MM BALLOON AT 10 ATM FOR 120 SECONDS. AT THE CONCLUSION OF THE CASE, NO THROMBUS OR DISSECTION WAS NOTED BY THE PHYSICIAN, AND THE ENTIRE LENGTH OF THE STUDY STENT WAS APPOSED TO THE VESSEL WALL. THERE WAS NO RESIDUAL STENOSIS REMAINING IN THE STUDY LESION. THE PROXIMAL AND DISTAL RVD WAS 5.0 MM. THE POST-PROCEDURAL ABI WAS 1.10 FOR THE STUDY LEG. ON THE SAME DAY, THE PATIENT WAS DISCHARGED FROM THE HOSPI

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6857897 ↗
• MalfunctionAug 17, 2017Fracture; Fracture

  THIS FOLLOW UP MDR IS BEING SUBMITTED AS IMAGE REVIEW WAS CONDUCTED. (B)(6) ¿ STENT FRACTURE. ON (B)(6) 2014, THE PATIENT RECEIVED TWO 6 MM X 80 MM ZILVER PTX STUDY STENTS IN THE RIGHT DISTAL SFA. ON (B)(6) 2014, THE PATIENT UNDERWENT PRE-DILATATION OF STUDY LESION WITH ONE INFLATION OF A 4.0 MM X 120 MM BALLOON AT 10 ATM FOR 10 SECONDS. TWO 6.0 MM X 80 MM (LOT #¿S C1004265) WERE PLACED IN THE RIGHT DISTAL SFA VIA CONTRALATERAL ACCESS. THE IMPLANTING PHYSICIAN NOTED THAT FOR EACH STENT 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 120 MM DILATATION BALLOON AT 10 ATM FOR 10 SECONDS. AT THE CONCLUSION OF THE CASE, NO THROMBUS OR DISSECTION WAS NOTED BY THE PHYSICIAN, AND THE ENTIRE LENGTH OF THE STUDY STENT WAS APPOSED TO THE VESSEL WALL. THERE WAS NO RESIDUAL STENOSIS REMAINING IN THE STUDY LESION. THE PROXIMAL RVD WAS 5.0 MM AND THE DISTAL RVD WAS 4.0 MM. THE POST-PROCEDURAL ABI WAS 0.67 FOR THE STUDY LEG. ON (B)(6) 2014, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL TAKING PLAVIX AND ASPIRIN. ON (B)(6) 2014, THE PATIENT STOPPED TAKING PLAVIX. ON (B)(6) 2015, THE TWELVE MONTH

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6800432 ↗
• InjuryNov 16, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  HYPERSENSITIVITY/ALLERGIC REACTION (RASH), " LOCAL NONSPECIFIC ERYTHEMATOUS MACULAR RASH OVER THE ANTERIOR ABDOMINAL WALL" 1 DAY AFTER PROCEDURE, TREATED WITH AN INJECTABLE STEROID AND SENT HOME WITH STEROID PRESCRIPTION. THE PHYSICIAN HAS DETERMINED THAT IT IS MORE LIKELY THAT THE PATIENT REACTED TO THE CONTRAST DYE INSTEAD OF THE STENT. THE RESPONSE TO THE QUESTION WAS THE EVENT THOUGHT TO BE RELATED TO THE STUDY PRODUCT. IS UNLIKELY.

  Patient problems: Rash

  MAUDE report 6105547 ↗
• InjuryNov 15, 2016Occlusion Within Device; Obstruction of Flow; Occlusion Within Device; Obstruction of Flow

  THIS FOLLOW UP REPORT IS BEING SUBMITTED DUE TO THE RECEIPT AND REVIEW OF IMAGES RELATING TO THIS EVENT: 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 RES

  Patient problems: Reocclusion

  MAUDE report 6102360 ↗
• InjuryAug 22, 2016Occlusion Within Device; Occlusion Within Device

  STUDY PROTOCOL (B)(6) - ZILVER PTX V; PT (B)(6) - WORSENED CLAUDICATION/REST PAIN. THE LESION MORPHOLOGY OF THE STUDY LESION IN THE LEFT DISTAL SFA INDICATED A TASC I AND TASC II, TYPE D LESION WITH SEVERE CALCIFICATION AND NO THROMBUS. INFLOW TRACT STENOSIS WAS GREATER THAN 50% AND THERE WERE THREE PATENT RUNOFF VESSELS. BASELINE ANGIOGRAPHIC LESION MEASUREMENTS REVEALED A PROXIMAL REFERENCE VESSEL DIAMETER (RVD) OF 6.0 MM, A DISTAL RVD OF 6.0 MM, AND 100% DIAMETER STENOSIS. THE LENGTH OF THE LESION WAS 60.0 MM. THE RIGHT AND LEFT ABIS MEASURED 0.69 AND 0.71, RESPECTIVELY. THE RIGHT AND LEFT RUTHERFORD CLASSIFICATIONS WERE ONE AND THREE, RESPECTIVELY. CORE LAB ANALYSIS OF THE PRE-PROCEDURE ANGIOGRAM REVEALED NO THROMBUS OR CALCIFICATION. THE IMAGING PROVIDED WAS NOT CONSIDERED OPTIMAL (NO DISTAL RUN-OFF IMAGES PROVIDED). TASC II CLASSIFICATION WAS NOT PROVIDED AND INFLOW TRACT AND DISTAL RUNOFF WERE NOT ASSESSED. BASELINE CORE LAB ANGIOGRAPHIC LESION MEASUREMENTS REVEALED A PROXIMAL RVD OF 5.69 MM, A DISTAL RVD OF 6.16 MM, AN MLD OF 0.0 MM, AND 100% DIAMETER STENOSIS. THE LENGTH OF THE LESION WAS NOT PROVIDED. THE LESION WAS PRE-DILATED WITH ONE INFLATION OF A 5 MM X 250 MM BALLOO

  Patient problems: Reocclusion

  MAUDE report 5892824 ↗
• InjuryAug 16, 2016Occlusion Within Device; Occlusion Within Device

  THE LESION MORPHOLOGY OF THE STUDY LESION IN THE RIGHT DISTAL SFA AND POPLITEAL ARTERY INDICATED A TASC I AND TASC II, TYPE B LESION WITH MILD CALCIFICATION AND NO THROMBUS. THE LESION WAS NOT PRE-DILATED. TWO 6 X 80 MM STUDY STENTS WERE DEPLOYED INTO THE RIGHT DISTAL SFA AND POPLITEAL ARTERY. POST-STENT DILATATION WAS PERFORMED. ON (B)(6) 2013 (DAY OF THE PROCEDURE), THE POST-PROCEDURE CLINICAL ASSESSMENT WAS COMPLETED. THE PATIENT CONTINUED TO TAKE CLOPIDOGREL AND ASPIRIN, HOWEVER ASPIRIN WAS DISCONTINUED LATER AT AN UNKNOWN DATE AND RESTARTED AGAIN ON (B)(6) 2015. ON (B)(6) 2014 (373 DAYS POST-PROCEDURE), THE 12-MONTH CLINICAL FOLLOW-UP AND IMAGING WERE COMPLETED. PATENCY OF THE STUDY LESION WAS ASSESSED BY ULTRASOUND EXAMINATION AND REVEALED THAT THE LESION WAS PATENT PROXIMAL TO, WITHIN, AND DISTAL TO THE STUDY LESION. THE CORE LAB ANALYSIS CONCURRED WITH THESE FINDINGS. THE X-RAY REVEALED NO STUDY STENT FRACTURES AND THE CORE LAB ANALYSIS CONCURRED. THE PATIENT CONTINUED TO TAKE CLOPIDOGREL. SINCE THE LAST CONTACT, THE PATIENT HAD NOT HAD ANY SIGNIFICANT MEDICAL PROBLEMS OR HOSPITALIZATIONS. ON (B)(6) 2015 (595 DAYS POST-PROCEDURE), THE PATIENT WAS HOSPITALIZED AND UNDERWENT

  Patient problems: Reocclusion

  MAUDE report 5878243 ↗
• InjuryAug 16, 2016Occlusion Within Device; Occlusion Within Device

  STUDY 12-004-ZILVER PTX V; PT # 1260032 - OCCLUSION/RESTENOSIS OF STUDY VESSEL. THE LESION MORPHOLOGY OF THE STUDY LESION IN THE RIGHT DISTAL SFA AND POPLITEAL ARTERY INDICATED A TASC I AND TASC II, TYPE B LESION WITH MILD CALCIFICATION AND NO THROMBUS. THERE WAS NO INFLOW TRACT STENOSIS GREATER THAN 50% AND THERE WERE TWO PATENT RUNOFF VESSELS. BASELINE ANGIOGRAPHIC LESION MEASUREMENTS REVEALED A PROXIMAL REFERENCE VESSEL DIAMETER (RVD) OF 6.0 MM, A DISTAL RVD OF 6.0 MM, AND 100% DIAMETER STENOSIS. THE LENGTH OF THE LESION WAS 58.0 MM. THE RIGHT AND LEFT ABIS MEASURED 0.41 AND 0.57, RESPECTIVELY. THE RIGHT AND LEFT RUTHERFORD CLASSIFICATIONS WERE BOTH TWO. CORE LAB ANALYSIS OF THE PRE-PROCEDURE ANGIOGRAM REVEALED A TASC II TYPE B LESION WITH MILD CALCIFICATION AND NO THROMBUS. THE INFLOW TRACT WAS NOT ASSESSED. THERE WERE TWO PATENT RUNOFF VESSELS. BASELINE CORE LAB ANGIOGRAPHIC LESION MEASUREMENTS REVEALED A PROXIMAL RVD OF 4.28 MM, A DISTAL RVD OF 4.28 MM, AN MLD OF 0.0 MM, AND 100% DIAMETER STENOSIS. THE LENGTH OF THE LESION WAS 106.3 MM. THE LESION WAS NOT PRE-DILATED. TWO 6 MM X 80 MM STUDY STENTS (LOT #S FOR BOTH C937507) WAS DEPLOYED INTO THE RIGHT DISTAL SFA AND POPLITEAL

  Patient problems: Reocclusion

  MAUDE report 5878241 ↗
• InjuryAug 8, 2016No Apparent Adverse Event; No Apparent Adverse Event

  THREE ZILVER GRAFTS WERE IMPLANTED IN THE PATIENTS LEFT LEG ON (B)(6) 2016. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND THE PATIENT HAD GREAT BLOOD. ON (B)(6) 2016, THE PATIENT CALLED BACK INTO THE OFFICE AND SPOKE WITH THE PHYSICIAN INDICATING SHE HAD A RAISED RASH FROM HER KNEE DOWN TO HER FOOT. THE PHYSICIAN TOLD THE PATIENT TO COME BACK INTO THE OFFICE STRAIGHT AWAY FOR EXAMINATION. UPON EXAMINATION BY THE PHYSICIAN, THERE WERE NO OTHER NOTED ALLERGIC REACTIONS OR COMPLICATIONS. THE PHYSICIAN PERFORMED A BLOOD TEST ON THE PATIENT AND CONFIRMED THERE WAS NO INFECTION. AT THIS POINT, THE PHYSICIAN BELIEVED THE RASH WAS STRICTLY SECLUDED TO THE LEFT LEG DUE TO THE IMPLANTED STENTS. THE PHYSICIAN PRESCRIBED A STEROID DOSE PACK FOR THE PATIENT. UPON FOLLOW UP ON 11JULY2016, THE RASH HAS REDUCED APPROXIMATELY 25%; HOWEVER 75% PERCENT OF THE RASH REMAINS. THE PATIENTS FAMILY IS EXTREMELY CONCERNED BECAUSE THE PATIENT WAS PLACED ON A BLOOD THINNER (PLAVIX), WHICH KEEPS THE STENTS OPEN. THE FACILITY BELIEVES THE REACTION IS NOT DUE TO THE PLAVIX, HOWEVER SOLELY RELATED TO THE IMPLANTED STENTS. AS THREE ZILVER STENTS ARE SUSPECTED TO BE INVOLVED IN THIS EVENT, A SEPARATE REPORT HAS BEEN

  Patient problems: Rash

  MAUDE report 5853747 ↗
• InjuryAug 8, 2016No Apparent Adverse Event; No Apparent Adverse Event

  THREE ZILVER GRAFTS WERE IMPLANTED IN THE PATIENTS LEFT LEG ON (B)(6) 2016. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND THE PATIENT HAD GREAT BLOOD. ON (B)(6) 2016 THE PATIENT CALLED BACK INTO THE OFFICE AND SPOKE WITH THE PHYSICIAN INDICATING SHE HAD A RAISED RASH FROM HER KNEE DOWN TO HER FOOT. THE PHYSICIAN TOLD THE PATIENT TO COME BACK INTO THE OFFICE STRAIGHT AWAY FOR EXAMINATION. UPON EXAMINATION BY THE PHYSICIAN, THERE WERE NO OTHER NOTED ALLERGIC REACTIONS OR COMPLICATIONS. THE PHYSICIAN PERFORMED A BLOOD TEST ON THE PATIENT AND CONFIRMED THERE WAS NO INFECTION. AT THIS POINT, THE PHYSICIAN BELIEVED THE RASH WAS STRICTLY SECLUDED TO THE LEFT LEG DUE TO THE IMPLANTED STENTS. THE PHYSICIAN PRESCRIBED A STEROID DOSE PACK FOR THE PATIENT. UPON FOLLOW UP ON (B)(6) 2016, THE RASH HAS REDUCED APPROXIMATELY 25%; HOWEVER 75% PERCENT OF THE RASH REMAINS. THE PATIENTS FAMILY IS EXTREMELY CONCERNED BECAUSE THE PATIENT WAS PLACED ON A BLOOD THINNER (PLAVIX), WHICH KEEPS THE STENTS OPEN. THE FACILITY BELIEVES THE REACTION IS NOT DUE TO THE PLAVIX, HOWEVER SOLELY RELATED TO THE IMPLANTED STENTS. AS THREE ZILVER STENTS ARE SUSPECTED TO BE INVOLVED IN THIS EVENT, A SEPARATE REPORT HAS BEEN

  Patient problems: Rash

  MAUDE report 5853352 ↗
• InjuryJul 14, 2016Occlusion Within Device; Occlusion Within Device

  (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 STUDY STENT WAS APPOSED TO THE VESSEL WALL, AND THERE WAS NO RESIDUAL STENOSIS REMAINING IN THE STUDY LESION. THE PROXIMAL AND DISTAL RVDS WERE 7.0 MM AND 6.0 MM, RESPECTIVELY. CORE LAB ANALYSIS OF THE FINAL LESION MORPHOLOGY REVEALED A PROXIMAL AND DISTAL RVD OF 5.41 MM, AN MLD OF 3.28 MM, AND 39.37% RESIDUAL STENOSIS. THERE WAS NO THROMBUS, PERFORATION, DISTAL EMBOLIZ

  Patient problems: Reocclusion

  MAUDE report 5794269 ↗
• InjuryJul 4, 2016Occlusion Within Device; Occlusion Within Device

  (B)(4), WORSENED CLAUDICATION PROBABLY RELATED TO THE STUDY PRODUCT/PROCEDURE. ON (B)(6) 2013, TWO 6.0 MM X 80 MM (LOT # C919314/ C910446) AND ZILVER® PTX® V STUDY STENTS WERE PLACED IN THE RIGHT DISTAL SUPERFICIAL FEMORAL ARTERY VIA CONTRALATERAL ACCESS. PRE-DILATATION WAS NOT PERFORMED. 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 5.0 MM X 150 MM DILATATION BALLOON AT 14 ATM FOR 17 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 ABIS WERE NOT PERFORMED. ON (B)(6) 2013 THE PATIENT WAS DISCHARGED FROM THE HOSPITAL TAKING BRILINTA®. ON (B)(6) 2014 THE PATIENT STOPPED TAKING BRILINTA® FOR AN UNKNOWN REASON. ON (B)(6 /2014 THE PATIENT RESUMED BRILINTA®. ON (B)(6) 2016 THE PATIENT EXPERIENCED WORSENING CLAUDICATION/REST PAIN. THE RIGHT LEG RUTHERFORD CLASSIFICATION WAS FOUR. THE LEFT LEG WAS NOT ASSESSE

  Patient problems: Reocclusion

  MAUDE report 5767915 ↗
• InjuryJul 4, 2016Occlusion Within Device; Occlusion Within Device

  (B)(6), WORSENED CLAUDICATION PROBABLY RELATED TO THE STUDY PRODUCT/PROCEDURE. ON (B)(6) 2013, TWO 6.0 MM X 80 MM (LOT # C919314/ C910446) AND ZILVER® PTX® V STUDY STENTS WERE PLACED IN THE RIGHT DISTAL SUPERFICIAL FEMORAL ARTERY VIA CONTRALATERAL ACCESS. PRE-DILATATION WAS NOT PERFORMED. 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 5.0 MM X 150 MM DILATATION BALLOON AT 14 ATM FOR 17 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 ABIS WERE NOT PERFORMED. ON (B)(6) 2013, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL TAKING BRILINTA®. ON (B)(6) 2014, THE PATIENT STOPPED TAKING BRILINTA® FOR AN UNKNOWN REASON. ON (B)(6) 2014, THE PATIENT RESUMED BRILINTA®. ON (B)(6) 2016 THE PATIENT EXPERIENCED WORSENING CLAUDICATION/REST PAIN. THE RIGHT LEG RUTHERFORD CLASSIFICATION WAS FOUR. THE LEFT LEG WAS NOT ASSE

  Patient problems: Reocclusion

  MAUDE report 5767914 ↗
• MalfunctionMay 17, 2016Device Expiration Issue; Device Expiration Issue

  USER FACILITY CALLED IN STATING A 2 DAY EXPIRED ZILVER PTX STENT HAS BEEN IMPLANTED INTO A PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5659713 ↗
• MalfunctionMay 3, 2016Premature Activation; Malposition of Device

  THEY WERE NOT AT THE TARGET LESION YET. THE PHYSICIAN NOTICED ON FLURO THAT THE ZILVER PTX STENT WAS PARTIALLY EXPOSED OUTSIDE OF THE SHEATH. THEY REMOVED THE DEVICE AND SUCCESSFULLY COMPLETED THE PROCEDURE WITH ANOTHER DEVICE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5626935 ↗
• MalfunctionMar 24, 2016Device Expiration Issue; Device Expiration Issue

  AREA REPRESENTATIVE MISTAKENLY PROVIDED EXPIRED DEVICE; DEVICE IMPLANTED IN PATIENT WITH NO COMPLICATIONS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5523039 ↗
• InjuryNov 20, 2014Occlusion Within Device

  (B)(6). TWO 6X80 ZILVER PTX STENTS IMPLANTED IN THE STUDY LESION. RE-INTERVENTION IN THE STUDY LESION DUE TO OCCLUSION/RE-STENOSIS, TREATED BY PTA AND STENT PLACEMENT ON (B)(6) 2014. PHYSICIAN STATES THAT THE CURRENT ADVERSE EVENT WAS "POSSIBLY" RELATED TO THE STUDY PRODUCT AND PROCEDURE. ALSO, IT WAS NOTED THAT THE PRE-EXISTING CONDITION OF PERIPHERAL ARTERY DISEASE MAY HAVE CAUSED OR CONTRIBUTED TO THIS ADVERSE EVENT. THIS PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2014. NO FURTHER ADVERSE EFFECTS TO THE PATIENT HAVE BEEN REPORTED AS OCCURRING. REFERENCE RELATED REPORT 3001845648-2014-00247.

  Patient problems: Occlusion

  MAUDE report 4283334 ↗
• InjuryOct 30, 2014Occlusion Within Device; Adverse Event Without Identified Device or Use Problem

  (B)(4). ADVERSE EVENT REPORTED: WORSENED CLAUDICATION/RESET PAIN. PHYSICIAN INDICATED "POSSIBLY RELATED TO STUDY PRODUCT". (B)(6) 2014 (133 DAYS POST PROCEDURE) RE-INTERVENTION IN STUDY LESION (BALLOON/STENTING), PATIENT DISCHARGED SAME DAY.

  Patient problems: Claudication; Insufficient Information; Pain; Surgical procedure, additional

  MAUDE report 4218782 ↗