Zilver PTX G24888Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 10827002248882), received between Mar 1, 2016 and Aug 14, 2019 — classified as 19 injuries, 1 malfunction.

The most frequently reported specific device problem is “Occlusion Within Device” (9 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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• InjuryAug 14, 2019Obstruction of Flow; Adverse Event Without Identified Device or Use Problem; Obstruction of Flow; Adverse Event Without Identified Device or Use Problem

  (B)(6) - 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 (B)(6) 2015 (FIVE DAYS POST-PROCEDURE), TAKING ASPIRIN AND PLAVIX. ON (B)(6) 2017 (561 DAYS POST-PROCEDURE), THE PATIENT EXPERIENCED AN OCCLUSION/RESTENOSIS OF THE STUDY LESION REQUIRING INTERVENTION. THE PATIENT CO

  Patient problems: Occlusion

  MAUDE report 8893347 ↗
• InjuryAug 13, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS REPORT IS BEING SUBMITTED AS A CANCELLATION REPORT BASED ON ADDITIONAL INFORMATION RECEIVED. ADDITIONAL INFORMATION INDICATES THAT A SUPERA STENT WAS PLACED OVER THE ZILVER STENT PRIOR TO THIS EVENT. THIS "EFFECTIVELY REMOVED THE ZILVER STENT FROM CIRCULATION" THEREFORE THIS EVENT IS NOT RELATED TO THE DEVICE. 12-004, STUDY PT, OCCLUSION/RESTENOSIS WITHIN & PROXIMAL TO STUDY LESION POSSIBLY RELATED TO STUDY PRODUCT. ONE ZILVER® PTX® V STUDY STENT WAS PLACED DURING THE INDEX PROCEDURE ON (B)(6) 2015. THE STUDY LESION WAS THE LEFT DISTAL SFA, 20 MM IN LENGTH, WITH 75% DIAMETER STENOSIS. THERE WERE TWO PATENT RUNOFF VESSELS. THE PATIENT UNDERWENT PRE-DILATATION OF STUDY LESION WITH ONE INFLATION OF A 5.0 X 40 MM BALLOON AT 12 ATM FOR 60 SECONDS. ONE ZILVER® PTX® V STUDY STENT WAS PLACED IN THE LEFT DISTAL SUPERFICIAL FEMORAL ARTERY VIA CONTRALATERAL ACCESS. POST-STENT DILATATION WAS PERFORMED WITH THREE INFLATIONS OF A 5.0 MM X 20 MM DILATATION BALLOON AT 20 ATM FOR 20 SECONDS, 30 SECONDS, AND 30 SECONDS. AT THE END OF THE CASE, THERE WAS 20% RESIDUAL STENOSIS REMAINING IN THE STUDY LESION, NO THROMBUS WAS PRESENT. ON THE SAME DAY, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL TAK

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8888381 ↗
• InjuryAug 8, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  NO FURTHER INFORMATION PROVIDED.

  Patient problems: Occlusion; Stenosis

  MAUDE report 8875690 ↗
• InjuryAug 5, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  TWO ZILVER PTX V STUDY STENTS WERE DEPLOYED DURING THE INDEX PROCEDURE ON (B)(6) 2015. THE STUDY LESION WAS THE RIGHT DISTAL SFA (SUPERFICIAL FEMORAL ARTERY) 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 (B)(6) 2015, TAKING ASPIRIN AND PLAVIX.. ON (B)(6) 2017, THE PATIENT EXPERIENCED AN OCCLUSION/RESTENOSIS OF THE STUDY LESION REQUIRING INTERVENTION. THE PATIENT CONTINUED TO TAKE ASPIRIN AND PLAVIX. THE SECONDARY INTERVENTION WAS PERFORMED, AND TREATMENT INCLUDED A BALLOON ANGIOPLASTY. THE PHYSICI

  Patient problems: Reocclusion; Stenosis

  MAUDE report 8861119 ↗
• InjuryJul 23, 2019Obstruction of Flow; Adverse Event Without Identified Device or Use Problem; Obstruction of Flow; Adverse Event Without Identified Device or Use Problem

  ONE ZILVER® PTX® V STUDY STENT WAS PLACED DURING THE INDEX PROCEDURE ON (B)(6) 2015. ON (B)(6) 2015, THE PATIENT UNDERWENT PRE-DILATATION OF STUDY LESION WITH ONE INFLATION OF A 5.0 X 40 MM BALLOON AT 12 ATM FOR 60 SECONDS. STUDY STENT WAS PLACED IN THE LEFT DISTAL SUPERFICIAL FEMORAL ARTERY VIA CONTRALATERAL ACCESS. THE IMPLANTING PHYSICIAN NOTED THAT EASE OF DEVICE DEPLOYMENT WAS NEITHER EASY NOR DIFFICULT. NO NON-STUDY STENTS WERE USED TO TREAT THE STUDY LESION. POST-STENT DILATATION WAS PERFORMED WITH THREE INFLATIONS OF A 5.0 MM X 20 MM DILATATION BALLOON AT 20 ATM FOR 20 SECONDS, 30 SECONDS, AND 30 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 20% RESIDUAL STENOSIS REMAINING IN THE STUDY LESION AND THE PROXIMAL AND DISTAL RVDS WERE 5.0 MM. THE POST-PROCEDURAL ABIS WERE NOT PERFORMED. ON THE SAME DAY, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL TAKING ASPIRIN AND CLOPIDOGREL. ON (B)(6) 2019 (1438 DAYS POST-PROCEDURE), THE PATIENT WAS SEEN DUE TO WORSENED CLAUDICATION/REST PAIN. ON (B)(6) 2019 (1465 DAYS POST-PROCEDURE), THE PATIENT UNDERWENT AN ULTRASO

  Patient problems: Pain

  MAUDE report 8816363 ↗
• MalfunctionMay 28, 2019Fracture; Fracture

  AS REPORTED TO CUSTOMER RELATIONS: ¿AT 1.5 YEARS, FOLLOW UP SEGMENTAL PRESSURES DEMONSTRATED ANKLE BRACHIAL INDICES IN THE CLAUDICATION RANGE AND MONOPHASIC WAVEFORMS FROM THE CFAS THROUGH THE ANKLES BILATERALLY. THIS SUGGESTED BILATERALLY AORTIC ILIAC HEMODYNAMICALLY SIGNIFICANT STENOSIS. ON THE RIGHT, THIS WAS FURTHER SUPPORTED BY INCREASED PSV AND SPECTRALLY BROADENING AT THE RIGHT ILIAC BYPASS LIMB AND CFA ANASTOMOSIS CONSISTENT WITH A NEW 50-90% STENOSIS. MULTIPLE IN-STENT STENOSES AND A POSSIBLE STENT FRACTURE IMPINGING ON THE MID-SFA LUMEN AND CAUSING A SMALL PSEUDOANEURYSM HAD DEVELOPED. ALTHOUGH ULTRASOUND CANNOT INFALLIBLY RESOLVE STENT LAYERS, ONLY ONE LAYER OF STENT WAS IMAGED AT THE SUSPECTED FRACTURE".

  Patient problems: Pseudoaneurysm

  MAUDE report 8646211 ↗
• InjuryNov 23, 2018Obstruction of Flow; Appropriate Device Problem Term/Code Not Available; Obstruction of Flow; Appropriate Device Problem Term/Code Not Available

  (B)(4), PT. EXPERIENCED AN OCCLUSION/RESTENOSIS WITHIN THE STUDY LESION, PROBABLY R/T STUDY PRODUCT & PROCEDURE. ONE ZILVER® PTX® V STUDY STENT WAS PLACED DURING THE INDEX PROCEDURE ON (B)(6) 2015. ON (B)(6) 2015, THE PATIENT RECEIVED ONE ZILVER PTX STUDY STENT IN THE RIGHT PROXIMAL SFA VIA A CONTRALATERAL ACCESS SITE. THE STUDY LESION WAS 20.0 MM IN LENGTH WITH 70% DIAMETER STENOSIS IN STUDY LESION. PRE-STENT DILATATION WAS NOT PERFORMED. POST-STENT DILATATION WAS PERFORMED. THERE WAS NO THROMBUS OR DISSECTION POST STENTING, WITH NO RESIDUAL STENOSIS REMAINING. ON (B)(6) 2018 (980 DAYS POST-PROCEDURE), THE PATIENT EXPERIENCED WORSENED AN OCCLUSION/RESTENOSIS WITHIN THE STUDY LESION. TREATMENT INCLUDED ATHERECTOMY AND DRUG COATED BALLOON ANGIOPLASTY ON (B)(6) 2018 (994 DAYS POST-PROCEDURE). [NOTE, THE SITE HAS NOT SUBMITTED THE SECONDARY INTERVENTION FORM YET, NO FURTHER INFORMATION IS AVAILABLE. THE EVENT WAS CONSIDERED PROBABLY RELATED TO THE STUDY PRODUCT AND THE STUDY PROCEDURE. [THE SITE HAS BEEN QUERIED REGARDING RATIONALE FOR PROBABLY RELATED TO STUDY PROCEDURE.] PRE-EXISTING PERIPHERAL ARTERIAL DISEASE WAS ALSO NOTED TO HAVE CAUSED OR CONTRIBUTED TO THE EVENT. THE SITE MARK

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8099400 ↗
• InjuryOct 11, 2018Mechanical Problem; Mechanical Problem

  THIS REPORT IS BEING SUBMITTED AS A CANCELLATION REPORT BASED ON ADDITIONAL INFORMATION. IT HAS BEEN CONFIRMED THAT A SUPERA STENT WAS INSERTED PRIOR TO THE EVENT BEING REPORTED IN THIS REPORT. THE SUPERA STENT COVERED THE COOK STENT WHICH, IT HAS BEEN CONFIRMED, "EFFECTIVELY REMOVED THE COOK STENT FROM CIRCULATION". 12-004, WORSENED CLAUDICATION/REST PAIN OF STUDY LEG, POSSIBLY RELATED TO STUDY LESION. ONE ZILVER® PTX® V STUDY STENT WAS PLACED DURING THE INDEX PROCEDURE ON (B)(6) 2015. THE STUDY LESION WAS THE LEFT DISTAL SFA, 20 MM IN LENGTH, WITH 75% DIAMETER STENOSIS. THERE WERE TWO PATENT RUNOFF VESSELS. THE PATIENT UNDERWENT PRE-DILATATION OF STUDY LESION WITH ONE INFLATION OF A 5.0 X 40 MM BALLOON AT 12 ATM FOR 60 SECONDS. ONE ZILVER® PTX® V STUDY STENT WAS PLACED IN THE LEFT DISTAL SUPERFICIAL FEMORAL ARTERY VIA CONTRALATERAL ACCESS. POST-STENT DILATATION WAS PERFORMED WITH THREE INFLATIONS OF A 5.0 MM X 20 MM DILATATION BALLOON AT 20 ATM FOR 20 SECONDS, 30 SECONDS, AND 30 SECONDS. AT THE END OF THE CASE, THERE WAS 20% RESIDUAL STENOSIS REMAINING IN THE STUDY LESION, NO THROMBUS WAS PRESENT. ON THE SAME DAY, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL TAKING ASPIRIN AND PL

  Patient problems: Pain

  MAUDE report 7955263 ↗
• InjuryJun 1, 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 SUBMITTED BASED ON SERIOUS INJURY. THE PATIENT EXPERIENCED AN OCCLUSION/RESTENOSIS OF THE STUDY LESION THAT REQUIRING INTERVENTION. THE SECONDARY INTERVENTION WAS PERFORMED AND TREATMENT INCLUDED A BALLOON ANGIOPLASTY. THIS REPORT ADDRESSES THE FOLLOWING INFORMATION: ON (B)(6) 2018, THE PATIENT EXPERIENCED AN OCCLUSION/RESTENOSIS OF THE STUDY LESION THAT REQUIRING INTERVENTION. THE SECONDARY INTERVENTION WAS PERFORMED AND TREATMENT INCLUDED A BALLOON ANGIOPLASTY. THE PHYSICIAN DETERMINED THAT THE OCCLUSION/RESTENOSIS OF THE STUDY LESION WAS PROBABLY RELATED TO THE STUDY PRODUCT, WAS UNLIKELY TO BE RELATED TO THE STUDY PROCEDURE. THE PATIENT¿S PRE-EXISTING PERIPHERAL VASCULAR DISEASE AND PRIOR SECONDARY INTERVENTION ON (B)(6) 2017 CAUSED OR CONTRIBUTED TO THIS EVENT. THE STUDY STENT DID NOT MALFUNCTION OR DETERIORATE IN CHARACTERISTICS OR PERFORMANCE. THE SITE NOTED: ¿RIGHT LEG ANGIOGRAPHY INDICATIONS: ARTERIAL INSUFFICIENCY; ATHEROSCLEROSIS WITH NO SIGNIFICANT INFLOW DISEASE; SEVERE IN-STENT STENOSIS OF THE SFA AND ABOVE KNEE POPLITEAL; PATENT ALL BELOW KNEE VESSELS INCLUDING PLANTARS AND DORS

  Patient problems: Occlusion

  MAUDE report 7560326 ↗
• InjuryApr 11, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INITIAL MDR BEING SUBMITTED DUE TO SERIOUS INJURY. THE PATIENT EXPERIENCED A RE-INTERVENTION DUE TO THROMBOSIS WITHIN THE STUDY LESION (RIGHT SFA). THE PATIENT WAS TREATED WITH ATHERECTOMY, BALLOON ANGIOPLASTY, THROMBECTOMY, STENT PLACEMENT AND AN EMERGENCY FASCIOTOMY FOR COMPARTMENT SYNDROME) (B)(6): OCCLUSION AND THROMBOSIS OF THE STUDY LESION REQUIRING INTERVENTION ON (B)(6) 2015, THE PATIENT RECEIVED ONE ZILVER PTX STUDY STENT (6 MM X 40 MM) IN THE RIGHT DISTAL SFA. ON (B)(6) 2018, THE PATIENT EXPERIENCED AN OCCLUSION/RESTENOSIS OF THE RIGHT LOWER EXTREMITY THAT THE INVESTIGATOR CONSIDERED POSSIBLY RELATED TO THE STUDY DEVICE. THE PATIENT WAS TREATED WITH ATHERECTOMY, BALLOON ANGIOPLASTY, THROMBECTOMY AND STENT PLACEMENT. PRE-EXISTING PERIPHERAL VASCULAR DISEASE WAS NOTED TO HAVE CAUSED OR CONTRIBUTED TO THIS EVENT. (B)(4) ON (B)(6) 2018, THE PATIENT EXPERIENCED A RE-INTERVENTION DUE TO THROMBOSIS WITHIN THE STUDY LESION (RIGHT SFA). THE PATIENT WAS TREATED WITH ATHERECTOMY, BALLOON ANGIOPLASTY, THROMBECTOMY, STENT PLACEMENT AND AN EMERGENCY FASCIOTOMY FOR COMPARTMENT SYNDROME. PRE-EXISTING PERIPHERAL VASCULAR DISEASE WAS NOTED TO HAVE CAUSED OR CONTRIBUTED TO THIS EVENT. (B)()

  Patient problems: Occlusion

  MAUDE report 7420744 ↗
• InjuryApr 11, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INITIAL MDR BEING SUBMITTED DUE TO SERIOUS INJURY. THE PATIENT WAS TREATED WITH ATHERECTOMY, BALLOON ANGIOPLASTY, THROMBECTOMY AND STENT PLACEMENT) DUE TO "OCCLUSION AND THROMBOSIS OF THE STUDY LESION ". (B)(4). ON (B)(6) 2015, THE PATIENT RECEIVED ONE ZILVER PTX STUDY STENT (6 MM X 40 MM) IN THE RIGHT DISTAL SFA. ON (B)(6) 2018, THE PATIENT EXPERIENCED AN OCCLUSION/RESTENOSIS OF THE RIGHT LOWER EXTREMITY THAT THE INVESTIGATOR CONSIDERED POSSIBLY RELATED TO THE STUDY DEVICE. THE PATIENT WAS TREATED WITH ATHERECTOMY, BALLOON ANGIOPLASTY, THROMBECTOMY AND STENT PLACEMENT. PRE-EXISTING PERIPHERAL VASCULAR DISEASE WAS NOTED TO HAVE CAUSED OR CONTRIBUTED TO THIS EVENT. (B)(4). ON (B)(6) 2018, THE PATIENT EXPERIENCED A RE-INTERVENTION DUE TO THROMBOSIS WITHIN THE STUDY LESION (RIGHT SFA). THE PATIENT WAS TREATED WITH ATHERECTOMY, BALLOON ANGIOPLASTY, THROMBECTOMY, STENT PLACEMENT AND AN EMERGENCY FASCIOTOMY FOR COMPARTMENT SYNDROME. PRE-EXISTING PERIPHERAL VASCULAR DISEASE WAS NOTED TO HAVE CAUSED OR CONTRIBUTED TO THIS EVENT. (B)(4). THE SITE MARKED NO (FOR EACH EVENT) TO THE QUESTION: DID THE DEVICE MALFUNCTION OR DETERIORATE IN CHARACTERISTICS OR PERFORMANCE?

  Patient problems: Occlusion

  MAUDE report 7420715 ↗
• InjuryApr 25, 2017Occlusion Within Device; Occlusion Within Device

  (B)(6) ¿ OCCLUSION/RESTENOSIS PROBABLY RELATED TO STUDY PRODUCT. AT THE INDEX PROCEDURE ON (B)(6) 2015, THE PATIENT RECEIVED ONE 6 MM X 40 MM AND ONE 6 MM X 100 MM ZILVER PTX STUDY STENT IN THE RIGHT DISTAL SFA AND POPLITEAL ARTERY. ON (B)(6) 2015, THE PATIENT UNDERWENT PRE-DILATATION OF STUDY LESION WITH ONE INFLATION OF A 6.0 X 100 MM BALLOON AT 16 ATM FOR 30 SECONDS. ONE 6.0 MM X 40 MM (LOT # C1134169) AND ONE 6 MM X 100 MM ZILVER® PTX® V STUDY STENTS WERE PLACED IN THE RIGHT DISTAL SFA AND POPLITEAL ARTERY 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 AT 10 ATM FOR 10 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 5.0 MM. THE POST-PROCEDURAL ABI WAS NOT PERFORMED FOR THE STUDY LEG. ON (B)(6) 2015 (FIVE DAYS POST-PROCEDURE), THE PATIENT WAS DISCHARGED FROM THE HOSPITA

  Patient problems: Ulcer

  MAUDE report 6517959 ↗
• InjuryApr 25, 2017Occlusion Within Device; Occlusion Within Device

  (B)(6) ¿ OCCLUSION/RESTENOSIS PROBABLY RELATED TO STUDY PRODUCT. AT THE INDEX PROCEDURE ON (B)(6) 2015, THE PATIENT RECEIVED ONE 6 MM X 40 MM AND ONE 6 MM X 100 MM ZILVER PTX STUDY STENT IN THE RIGHT DISTAL SFA AND POPLITEAL ARTERY. ON (B)(6) 2015, THE PATIENT UNDERWENT PRE-DILATATION OF STUDY LESION WITH ONE INFLATION OF A 6.0 X 100 MM BALLOON AT 16 ATM FOR 30 SECONDS. ONE 6.0 MM X 40 MM (LOT # C1134169) AND ONE 6 MM X 100 MM ZILVER® PTX® V STUDY STENTS WERE PLACED IN THE RIGHT DISTAL SFA AND POPLITEAL ARTERY 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 AT 10 ATM FOR 10 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 5.0 MM. THE POST-PROCEDURAL ABI WAS NOT PERFORMED FOR THE STUDY LEG. ON (B)(6) 2015 (FIVE DAYS POST-PROCEDURE), THE PATIENT WAS DISCHARGED FROM THE HOSPITA

  Patient problems: Occlusion

  MAUDE report 6517942 ↗
• InjuryMar 7, 2017Occlusion Within Device; Occlusion Within Device

  THE PATIENT WAS ENROLLED IN THE STUDY TO TREAT THE LEFT DISTAL SUPERFICIAL FEMORAL ARTERY. THE RIGHT AND LEFT ABIS WERE NOT PERFORMED. THE RIGHT AND LEFT RUTHERFORD CLASSIFICATIONS WERE TWO AND THREE RESPECTIVELY. THE LESION MORPHOLOGY REVEALED A TASC I AND TASC II, TYPE A LESION WITH NO CALCIFICATION OR THROMBUS. THERE WAS NO PREVIOUS INTERVENTION IN THE STUDY LESION. THERE WAS NO INFLOW TRACT STENOSIS GREATER THAN 50% AND THERE WERE TWO PATENT RUNOFF VESSELS. BASELINE ANGIOGRAPHIC LESION MEASUREMENTS REVEALED A PROXIMAL AND DISTAL REFERENCE VESSEL DIAMETER (RVD) OF 5.0 MM AND 75% DIAMETER STENOSIS. THE LESION LENGTH WAS 20.0 MM. ON (B)(6) 2015, THE PATIENT UNDERWENT PRE-DILATATION OF STUDY LESION WITH ONE INFLATION OF A 5.0 X 40 MM BALLOON AT 12 ATM FOR 60 SECONDS. ONE 6.0 MM X 40 MM (LOT # C1066803) 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 NEITHER EASY NOR DIFFICULT. NO NON-STUDY STENTS WERE USED TO TREAT THE STUDY LESION. POST-STENT DILATATION WAS PERFORMED WITH THREE INFLATIONS OF A 5.0 MM X 20 MM DILATATION BALLOON AT 20 ATM FOR 20 SECONDS, 30

  Patient problems: Reocclusion

  MAUDE report 6383613 ↗
• InjuryNov 17, 2016Occlusion Within Device; Occlusion Within Device

  (B)(6): OCCLUSION/RESTENOSIS OF THE STUDY LESION, RIGHT DISTAL SFA. ON (B)(6) 2015 THE PATIENT RECEIVED ONE ZILVER PTX STUDY STENT (6 MM X 40 MM) IN THE RIGHT DISTAL SFA. ON (B)(6) 2016, THE PATIENT UNDERWENT PERCUTANEOUS INTERVENTION FOR OCCLUSION/RESTENOSIS OF THE STUDY LESION AND DISTAL TO THE STUDY LESION. INTERVENTION INCLUDED ATHERECTOMY AND BALLOON ANGIOPLASTY. THE INVESTIGATOR NOTED THAT THE EVENT (OCCLUSION/RESTENOSIS) WAS POSSIBLY RELATED TO THE STUDY PRODUCT AND POSSIBLY RELATED TO THE STUDY PROCEDURE. PRE-EXISTING ATHEROSCLEROSIS AND TYPE II DIABETES WERE ALSO NOTED TO HAVE CAUSED OR CONTRIBUTED TO THE EVENT.

  Patient problems: Reocclusion

  MAUDE report 6108961 ↗
• InjurySep 21, 2016Occlusion Within Device; Occlusion Within Device

  THIS FOLLOW UP REPORT IS BEING SUBMITTED DUE TO THE RECEIPT OF ADDITIONAL INFORMATION RELATING TO THE TREATMENT RECEIVED BY THE PATIENT AS FOLLOWS: ON 11/30/16 ¿ SITE REPORTED A NON-HEALING WOUND (RESULTING FROM RIGHT THIRD TOE AMPUTATION) WITH AN ONSET DATE OF (B)(6) 2016 (POSITIVE FOR GROUP B STREP). THE PATIENT UNDERWENT WOUND DEBRIDEMENT, PICC LINE PLACEMENT AND IV ANTIBIOTIC ADMINISTRATION. THE EVENT END DATE WAS NOTED TO BE (B)(6) 2016. THE STUDY SITE ALSO NOTED THAT THE NON-HEALING WOUND WAS POSSIBLY RELATED TO THE STUDY DEVICE AND STUDY PROCEDURE AND THAT THE DEVELOPMENT OF OSTEOMYELITIS CAUSED/CONTRIBUTED TO THE NON-HEALING WOUND.

  Patient problems: Reocclusion

  MAUDE report 5965883 ↗
• InjurySep 21, 2016Occlusion Within Device; Occlusion Within Device

  (B)(6): OSTEOMYELITIS RIGHT 3RD TOE. ON (B)(6) 2015, THE PATIENT UNDERWENT PRE-DILATATION OF STUDY LESION ONE, IN THE RIGHT DISTAL SFA, WITH ONE INFLATION OF A 4.0 X 20 MM BALLOON AT 6 ATM FOR 51 SECONDS. ONE 6.0 MM X 40 MM (LOT # C1105140) ZILVER® PTX® V STUDY STENT WAS PLACED IN THE RIGHT DISTAL SUPERFICIAL FEMORAL ARTERY VIA CONTRALATERAL ACCESS. THE IMPLANTING PHYSICIAN NOTED THAT EASE OF DEVICE DEPLOYMENT WAS NEITHER EASY NOR DIFFICULT. NO NON-STUDY STENTS WERE USED TO TREAT THE STUDY LESION. POST-STENT DILATATION WAS PERFORMED WITH THREE INFLATIONS OF A 5.0 MM X 20 MM DILATATION BALLOON AT 6 ATM FOR 28 SECONDS, 6 ATM FOR 53 SECONDS, AND 8 ATM FOR 46 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 5% RESIDUAL STENOSIS REMAINING IN THE STUDY LESION AND THE PROXIMAL AND DISTAL RVDS WERE 5.4 MM. THE POST-PROCEDURAL ABIS WERE NOT PERFORMED. ON 10/09/2015, THE PATIENT UNDERWENT PRE-DILATATION OF STUDY LESION TWO, IN THE RIGHT PROXIMAL SFA, WITH ONE INFLATION OF A 4.0 X 20 MM BALLOON AT 6 ATM FOR 55 SECONDS. ONE 6.0 MM X 40 MM (LOT # C1101487) ZILVER® PTX® V ST

  Patient problems: Reocclusion

  MAUDE report 5965880 ↗
• InjuryApr 4, 2016Occlusion Within Device; Occlusion Within Device

  (B)(6), OCCLUSION/RESTENOSIS OF THE STUDY LESION REQUIRING INTERVENTION DEFINITELY RELATED TO THE STUDY PRODUCT. THE PATIENT WAS ENROLLED IN THE STUDY TO TREAT THE LEFT DISTAL SUPERFICIAL FEMORAL ARTERY. THE RIGHT AND LEFT ABIS WERE NOT PERFORMED. THE RIGHT AND LEFT RUTHERFORD CLASSIFICATIONS WERE TWO AND THREE RESPECTIVELY. THE LESION MORPHOLOGY REVEALED A TASC I AND TASC II, TYPE A LESION WITH NO CALCIFICATION OR THROMBUS. THERE WAS NO PREVIOUS INTERVENTION IN THE STUDY LESION. THERE WAS NO INFLOW TRACT STENOSIS GREATER THAN 50% AND THERE WERE TWO PATENT RUNOFF VESSELS. BASELINE ANGIOGRAPHIC LESION MEASUREMENTS REVEALED A PROXIMAL AND DISTAL REFERENCE VESSEL DIAMETER (RVD) OF 5.0 MM AND 75% DIAMETER STENOSIS. THE LESION LENGTH WAS 20.0 MM. ON (B)(6) 2015, THE PATIENT UNDERWENT PRE-DILATATION OF STUDY LESION WITH ONE INFLATION OF A 5.0 X 40 MM BALLOON AT 12 ATM FOR 60 SECONDS. ONE 6.0 MM X 40 MM (LOT # C1066803) 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 NEITHER EASY NOR DIFFICULT. NO NON-STUDY STENTS WERE USED TO TREAT THE STUDY LESION. POST-STENT DIL

  Patient problems: Reocclusion

  MAUDE report 5543652 ↗
• InjuryMar 1, 2016Occlusion Within Device; Occlusion Within Device

  ON (B)(6) 2015, THE PATIENT UNDERWENT PRE-DILATATION OF STUDY LESION ONE, IN THE RIGHT DISTAL SFA, WITH ONE INFLATION OF A 4.0 X 20 MM BALLOON AT 6 ATM FOR 51 SECONDS. ONE 6.0 MM X 40 MM (LOT # C1105140) ZILVER® PTX® V STUDY STENT WAS PLACED IN THE RIGHT DISTAL SUPERFICIAL FEMORAL ARTERY VIA CONTRALATERAL ACCESS. THE IMPLANTING PHYSICIAN NOTED THAT EASE OF DEVICE DEPLOYMENT WAS NEITHER EASY NOR DIFFICULT. NO NON-STUDY STENTS WERE USED TO TREAT THE STUDY LESION. POST-STENT DILATATION WAS PERFORMED WITH THREE INFLATIONS OF A 5.0 MM X 20 MM DILATATION BALLOON AT 6 ATM FOR 28 SECONDS, 6 ATM FOR 53 SECONDS, AND 8 ATM FOR 46 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 5% RESIDUAL STENOSIS REMAINING IN THE STUDY LESION AND THE PROXIMAL AND DISTAL RVDS WERE 5.4 MM. THE POST-PROCEDURAL ABIS WERE NOT PERFORMED.

  Patient problems: Thrombosis

  MAUDE report 5469811 ↗
• InjuryMar 1, 2016Occlusion Within Device; Occlusion Within Device

  PROTOCOL 12-004, PT. (B)(6), THROMBOSIS OF THE STUDY LESION POSSIBLY RELATED TO THE STUDY PRODUCT. ON (B)(6) 2015, THE PATIENT UNDERWENT PRE-DILATATION OF STUDY LESION ONE, IN THE RIGHT DISTAL SFA, WITH ONE INFLATION OF A 4.0 X 20 MM BALLOON AT 6 ATM FOR 51 SECONDS. ONE 6.0 MM X 40 MM (LOT # C1105140) ZILVER® PTX® V STUDY STENT WAS PLACED IN THE RIGHT DISTAL SUPERFICIAL FEMORAL ARTERY VIA CONTRALATERAL ACCESS. THE IMPLANTING PHYSICIAN NOTED THAT EASE OF DEVICE DEPLOYMENT WAS NEITHER EASY NOR DIFFICULT. NO NON-STUDY STENTS WERE USED TO TREAT THE STUDY LESION. POST-STENT DILATATION WAS PERFORMED WITH THREE INFLATIONS OF A 5.0 MM X 20 MM DILATATION BALLOON AT 6 ATM FOR 28 SECONDS, 6 ATM FOR 53 SECONDS, AND 8 ATM FOR 46 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 5% RESIDUAL STENOSIS REMAINING IN THE STUDY LESION AND THE PROXIMAL AND DISTAL RVDS WERE 5.4 MM. THE POST-PROCEDURAL ABIS WERE NOT PERFORMED. ON (B)(6) 2015, THE PATIENT UNDERWENT PRE-DILATATION OF STUDY LESION TWO, IN THE RIGHT PROXIMAL SFA, WITH ONE INFLATION OF A 4.0 X 20 MM BALLOON AT 6 ATM FOR 55

  Patient problems: Thrombosis

  MAUDE report 5469589 ↗