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GORE TAG Conformable Thoracic Endoprosthesis TGU404020Recalls & reported problems

W. L. Gore & Associates, Inc. · TAG THORACIC ENDO CONFORM 40mmX20cm 24Fr · Class 3 · Implant

All models of GORE TAG Conformable Thoracic Endoprosthesis (20)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
14
Deaths reported
1
Injuries reported
12
Recalls naming it
0

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00733132617760), received between Jul 13, 2018 and May 17, 2024 — classified as 1 death, 12 injuries, 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (3 reports).

6 other recalls cover devices cleared under the same FDA submission (P040043); they may or may not involve this specific model.

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.

Reports received per month

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 1 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520261
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Adverse Event Without Identified Device or Use Problem5
  • Insufficient Device Problem Information3
  • Patient-Device Incompatibility2
  • Activation Failure1
  • Activation, Positioning or Separation Problem1
  • Device Dislodged or Dislocated1
  • Improper or Incorrect Procedure or Method1
  • Material Separation1

Patient problems

  • Aneurysm6
  • Vascular Dissection3
  • Clinical Endoleak1
  • Death1
  • Device Embedded In Tissue or Plaque1
  • Infarction, Cerebral1
  • Insufficient Information1
  • No Code Available1

Recent adverse event reports

The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

  • InjuryMay 17, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

    THE FOLLOWING INFORMATION WAS REPORTED TO GORE: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE TO TREAT A DESCENDING THORACIC AORTIC ANEURYSM USING A NON-GORE DEVICE. ON (B)(6), 2015, A REINTERVENTION OF A PRIOR ENDOVASCULAR PROCEDURE WAS DONE TO TREAT A ZONE 4 DESCENDING THORACIC AORTIC ANEURYSM USING A CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESIS (TGU404020/ 14185643). THE PATIENT TOLERATED THE PROCEDURE AND DISCHARGED HOME ON (B)(6), 2015. REPORTEDLY, PRE-TREATMENT CTA SHOWED THAT THE MAXIMUM DIAMETER OF THE AORTIC ANEURYSM/LESION WAS 65MM. THE FOLLOW UP CTA ON (B)(6) 2017, SHOWED THAT THE MAXIMUM DIAMETER OF THE AORTIC ANEURYSM/LESION WAS 61MM. ON (B)(6), 2017, THE PATIENT UNDERWENT AN ADDITIONAL ZONE 2 DESCENDING THORACIC AORTIC ANEURYSM TREATMENT WITH A PROXIMAL TYPE I ENDOLEAK FROM THE PREVIOUS REPAIR USING A GORE® TAG® THORACIC ENDOPROSTHESIS AND GORE® TAG® THORACIC BRANCH ENDOPROSTHESES. ADDITIONALLY, THE PATIENT UNDERWENT REVASCULARIZATION PROCEDURE. THE PATIENT TOLERATED THE PROCEDURE AND DISCHARGED HOME ON (B)(6), 2017. ON (B)(6), 2017, THE FOLLOW UP CTA SHOWED THAT THE MAXIMUM DIAMETER OF THE AORTIC ANEURYSM/LESION WAS 33MM.

    Patient problems: Clinical Endoleak

    MAUDE report 19347765 ↗
  • InjuryFeb 9, 2023Activation, Positioning or Separation Problem; Insufficient Device Problem Information; Activation, Positioning or Separation Problem; Insufficient Device Problem Information

    ON (B)(6) 2018, THE PATIENT UNDERWENT TREATMENT OF A THORACIC AORTIC ANEURYSM PROXIMAL TO THE BRACHIOCEPHALIC TRUNK, DISTAL TO THE SINOTUBULAR JUNCTION (ZONE 0) WITH CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESES AND GORE® TAG® THORACIC BRANCH ENDOPROSTHESES. ON (B)(6) 2018, PRE-TREATMENT IMAGING SHOWED THAT THE MAXIMUM ANEURYSM/ LESION WAS 66MM. FROM ON (B)(6) 2018 TILL ON (B)(6) 2019 THE ANEURYSM WAS STABLE 59MM. FROM ON (B)(6) 2020 TILL ON (B)(6) 2021, THE MAXIMUM ANEURYSM/ LESION INCREASED IN SIZE FROM 53MM TO 62 MM. ACCORDING TO THE PHYSICIAN, THERE WAS NO ENDOLEAK FOUND ON CT IMAGES. THE CAUSE OF THE ANEURYSM ENLARGEMENT IS UNKNOWN. THE EVENT IS ONGOING. NO TREATMENT WAS REPORTED. THE PHYSICIAN IS MONITORING THE PATIENT.

    Patient problems: Aneurysm

    MAUDE report 16343338 ↗
  • InjuryDec 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2019, THE PATIENT UNDERWENT TREATMENT OF UNKNOWN PATHOLOGY OF THE DESCENDING THORACIC AORTIC (ZONE 0) WITH A CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESIS AND GORE® TAG® THORACIC BRANCH ENDOPROSTHESES. IT IS UNKNOWN IF THE PATIENT WAS BEING TREATED FOR A DISSECTION OR AN ANEURYSM, HOWEVER, THERE IS NO GROWTH IN THE MAXIMUM AORTIC DIAMETER WITHIN THE TREATED SEGMENT. IMAGES DATED (B)(6) 2021, REVEALED A DISTAL TYPE I ENDOLEAK. REPORTEDLY, A POSSIBLE REINTERVENTION IS BEING PLANNED.

    Patient problems: Insufficient Information

    MAUDE report 12954512 ↗
  • InjurySep 1, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

    THE FOLLOWING WAS REPORTED: ON (B)(6) 2021, THE FIELD SALES ASSOCIATE (FSA) WAS SUPPORTING A CASE TO REINTERVENE ON A PSEUDOANEURYSM OF THE PROXIMAL ANASTOMOSIS SITE OF A 24MM INFRARENAL AORTOBIFEMORAL SURGICAL GRAFT. THE PATIENT IS BELIEVED TO HAVE INITIALLY PRESENTED IN 2017 OR 2018 WITH A TYPE A DISSECTION WITH EXTENSION INTO THE ILIAC ARTERIES, AND HAD THE FOLLOWING PROCEDURES PRIOR TO THE PLANNED REINTERVENTION OF THE PROXIMAL ANASTOMOSIS SITE: AORTIC VALVE AND ASCENDING SURGICAL REPLACEMENT. REDO STERNOTOMY FOR SURGICAL ARCH REPLACEMENT WITH A 32MM DACRON ELEPHANT TRUNK. PLACEMENT OF A CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESIS (TGU404020/16281848) IN THE ELEPHANT TRUNK (PERFORMED ON (B)(6) 2018). AT LEAST 2 OTHER CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESES (TGM343415/21013776 AND TGMR404015/20998160) WERE PUT IN DISTAL TO THE TGU404020 INFRARENAL AORTOBIFEMORAL SURGICAL GRAFT.NO COMPUTED TOMOGRAPHY (CT) SCAN WAS PROVIDED TO THE FSA PRIOR TO THE CASE. DURING THE CASE ON (B)(6) 2021, IT WAS OBSERVED ON FLUORO THAT THERE WERE POTENTIAL STENT FRACTURES IN THE MOST PROXIMAL CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESIS (TGU404020 STENT GRAFT) THAT WAS PREVIOUSLY PLACED IN

    Patient problems: Pseudoaneurysm; Vascular Dissection

    MAUDE report 12411381 ↗
  • InjuryJun 18, 2020Patient-Device Incompatibility; Patient-Device Incompatibility

    ON (B)(6) 2019 THE PATIENT UNDERWENT ENDOVASCULAR REPAIR OF A THORACIC AORTIC ANEURYSM WITHOUT RUPTURE USING A CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESIS. DURING CT FOLLOW-UP ON (B)(6) 2020 A SUSPECTED DISTAL TYPE I ENDOLEAK WAS IDENTIFIED. IT WAS NOTED THAT A POSSIBLE TYPE II ENDOLEAK HAD BEEN BEING MONITORED. ANEURYSM ENLARGEMENT WAS ALSO REPORTED. THE ANEURYSM WAS REPORTED TO HAVE EXPANDED FROM 6.9CM TO 7.1CM. ON (B)(6) 2020 A REINTERVENTION WAS PERFORMED TO TREAT THE SUSPECTED DISTAL TYPE I ENDOLEAK. THE DISTAL TYPE I ENDOLEAK WAS CONFIRMED. REPORTEDLY NO TYPE II ENDOLEAK WAS CONFIRMED OR TREATED. THE PREVIOUSLY IMPLANTED CTAG DEVICE WAS EXTENDED USING A GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM. THE DISTAL TYPE I ENDOLEAK WAS SUCCESSFULLY TREATED. THERE WERE NO FURTHER REPORTED ISSUES. THE PATIENT TOLERATED THE PROCEDURE.

    Patient problems: Aneurysm

    MAUDE report 10172086 ↗
  • DeathFeb 5, 2020Improper or Incorrect Procedure or Method; Activation Failure; Improper or Incorrect Procedure or Method; Activation Failure

    IT WAS REPORTED TO GORE THAT ON (B)(6) 2020, A CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESIS WAS TO BE IMPLANTED DURING TREATMENT OF A THORACIC AORTA ULCER. WHEN THE DEVICE WAS ADVANCED TO THE TARGET LESION THROUGH THE GORE DRYSEAL SHEATH WITH HYDROPHILIC COATING(DSL2428), THE PHYSICIAN INITIATED THE DEPLOYMENT LINE ,AFTER THE WHOLE DEPLOYMENT LINE WAS PULLED OUT , THE DEVICE EXPANDED SUCCESSFULLY ,ONLY EXCEPT THAT ABOUT 3-4CM OF THE PROXIMAL END OF THE DEVICE COULDN¿T EXPAND. THE PHYSICIAN TRIED TO USE THE BALLOON(GORE TRI-LOBE BALLOON CATHETER) TO DILATE BUT THE BALLOON DIDN¿T GO THROUGH. THEN THE PATIENT WAS TRANSFERRED TO THE CARDIAC SURGERY DEPARTMENT FOR SURGICAL INTERVENTION. THE PHYSICIAN FOUND THE DEVICE AND CUT THE SEWN DEPLOYMENT SLEEVE. THE DEVICE EXPANDED AND THE DELIVERY CATHETER WAS RETRACTED. THE PATIENT¿S VITAL PRESSURE AND OTHER VITAL SIGNS WERE STABLE. THEN THE ABDOMINAL AORTIC DISSECTION AND LEFT ILIAC ARTERY DISSECTION WERE SEEN UNDER THE ANGIOGRAPHY. THE LIFETECH38-34-200(LOCAL BRAND) STENT WAS IMPLANTED IN DESCENDING AORTA. IT WAS SEEN THAT THE RIGHT COMMON ILIAC ARTERY WAS RUPTURED UNDER THE ANGIOGRAPHY WHEN GORE DRYSEAL SHEATH WAS RETRACTED FROM THE PATIEN

    Patient problems: Death; Infarction, Cerebral; No Code Available

    MAUDE report 9674758 ↗
  • InjuryDec 12, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    ON (B)(6) 2013, THE PATIENT WAS IMPLANTED WITH A CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESES TO TREAT A DESCENDING THORACIC AORTIC ANEURYSM. IT WAS REPORTED THAT FOLLOW-UP IMAGES (MODALITY AND DATE IS UNKNOWN) REVEALED THE PATIENT DEVELOPED AN ENDOLEAK THAT WAS STABLE. IT WAS UNCLEAR WHETHER IT WAS A TYPE II ENDOLEAK OR PROXIMAL TYPE I ENDOLEAK, AT THE TIME OF DISCOVERY. THE PHYSICIAN TOOK A WAIT AND WATCH APPROACH. COMPUTER TOMOGRAPHY (CT) IMAGES DATED (B)(6) 2019, REVEALED THE ANEURYSM SAC HAD ENLARGED SIGNIFICANTLY. IMAGES DATED (B)(6) 2017 REVEALED THE ANEURYSM MEASURED 54MM, IMAGES DATED (B)(6) 2018 REVEALED THE ANEURYSM MEASURED 54.5MM, IMAGES DATED (B)(6) 2019 REVEALED THE ANEURYSM MEASURED 58MM, AND IMAGES DATED (B)(6) 2019 REVEALED THE ANEURYSM MEASURED 69MM. AN ANGIOGRAM (DATE UNKNOWN) CONFIRMED AN ENDOLEAK. ON (B)(6) 2019, THE PHYSICIAN REINTERVENED AND SUCCESSFUL PROXIMAL EXTENSION OF THE PRIOR TEVAR WAS PERFORMED USING AN AORTIC TAG THORACIC ENDOPROSTHESIS (CTAG WITH ACTIVE CONTROL (B)(4)) EXTENDING TO THE LEFT COMMON CAROTID ARTERY. THE LEFT SUBCLAVIAN ARTERY WAS THEN EMBOLIZED AT THE SAME SETTING USING A 14 MM AMPLATZER PLUG. THE PATIENT TOLERATED THE PROCEDURE.

    Patient problems: Aneurysm

    MAUDE report 9461599 ↗
  • InjuryOct 19, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2019, THE PATIENT UNDERWENT TREATMENT OF UNKNOWN PATHOLOGY OF THE DESCENDING THORACIC AORTIC (ZONE 0) WITH A CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESIS AND GORE® TAG® THORACIC BRANCH ENDOPROSTHESES. ON (B)(6) 2019 A CT WAS PERFORMED. ON (B)(6) 2019 THE RESULTS OF THE (B)(6) 2019 CT WERE UPDATED AND REVEALED A NEW AORTIC DISSECTION JUST DISTAL TO THE CTAG 1 DEVICE. COIL FAILURE WAS OBSERVED IN THE LSA. RETROGRADE FLOW WAS OBSERVED THROUGH THE COIL TO THE AORTIC COMPONENT. THERE ARE ALSO TYPE II ENDOLEAKS, HOWEVER THEY ARE RELATED TO THE INVESTIGATIONAL AORTIC COMPONENTS. THE EVENT IS ONGOING. THIS EVENT ADDRESSES THE NEW DISSECTION.

    Patient problems: Vascular Dissection

    MAUDE report 9211779 ↗
  • InjurySep 14, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2019, THE PATIENT UNDERWENT TREATMENT OF UNKNOWN PATHOLOGY OF THE DESCENDING THORACIC AORTIC (ZONE 0) WITH A CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESIS AND GORE® TAG® THORACIC BRANCH ENDOPROSTHESES. ON (B)(6) 2019, THE PATIENT HAD A RIGHT POPLITEAL ARTERY ACUTE OCCLUSIVE THROMBOSIS WITHOUT SYMPTOMS. THE EVENT IS ONGOING.

    Patient problems: Thrombosis

    MAUDE report 9056204 ↗
  • InjuryMay 24, 2019Patient-Device Incompatibility; Patient-Device Incompatibility

    THE FOLLOWING INFORMATION WAS REPORTED USING AN IDE (B)(4) EMERGENCY USE REPORT FOR THE GORE® ASCENDING STENT GRAFT DEVICE: ON (B)(6) 2015 THE PATIENT UNDERWENT ENDOVASCULAR REPAIR OF A THORACIC AORTIC ANEURYSM USING A CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESIS. IN (B)(6) 2015 THE PATIENT PRESENTED WITH HYPERTENSIVE EMERGENCY, AND A DISSECTING DESCENDING AORTIC ANEURYSM. ON (B)(6) 2015 THE PATIENT UNDERWENT ENDOVASCULAR REPAIR OF THE DESCENDING THORACIC AORTA USING TWO ADDITIONAL CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESES TO TREAT THE DISSECTING AORTIC ANEURYSM. ON (B)(6) 2019 THE PATIENT PRESENTED WITH HEMOPTYSIS. A COMPUTED TOMOGRAPHY ANGIOGRAPHY REVEALED AREAS WITH EXTRA AORTIC FLUID COLLECTION. A PSEUDOANEURYSM WAS SUSPECTED. ON (B)(6) 2019 A PSEUDOANEURYSM ARISING FROM THE VEIN GRAFT SITE IN THE ASCENDING AORTA WAS CONFIRMED DURING SURGICAL WORKUP. THE PATIENT WAS ADMITTED TO AN OUTSIDE HOSPITAL WITH LOWER EXTREMITY WEAKNESS, NAUSEA, VOMITING AND DIARRHEA. THE PATIENT WAS TRANSFERRED TO THE UNIVERSITY OF PENNSYLVANIA HOSPITAL FOR FURTHER MANAGEMENT DUE TO SUSPECTED WORSENING OF A TYPE III ENDOLEAK, AND SUSPECTED PSEUDOANEURYSM GROWTH. ON (B)(6) 2019 THE PATIENT UNDERWE

    Patient problems: Aneurysm

    MAUDE report 8640849 ↗
  • InjuryMay 24, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    ON (B)(6) 2018 A PATIENT UNDERWENT TREATMENT OF A THORACIC AORTIC DISSECTION, ZONE 2, WITH TWO GORE® TAG® THORACIC BRANCH ENDOPROSTHESES AND ONE CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESES AS DISTAL EXTENSION TO AORTIC COMPONENT. THE PRE-TREATMENT MAXIMUM AORTIC DIAMETER WITHIN THE TREATMENT ZONE WAS 53.1MM. ACCORDING TO THE REPORT ALL DEVICES WERE POSITIONED AND IMPLANTED WITHOUT ISSUE. ON (B)(6) 2018 THE PATIENT EXHIBITED A TYPE II ENDOLEAK. THE MAXIMUM AORTIC DIAMETER WITHIN THE TREATMENT ZONE WAS 81.9MM ON (B)(6) 2019 A REINTERVENTION TOOK PLACE WHEREBY AN EXTENSION DEVICE WAS IMPLANTED.

    Patient problems: Aneurysm

    MAUDE report 8640419 ↗
  • InjuryMar 15, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

    THE FOLLOWING INFORMATION WAS REPORTED TO GORE THROUGH THE GLOBAL REGISTRY FOR ENDOVASCULAR AORTIC TREATMENT (GREAT 10-11): ON (B)(6) 2014, THE PATIENT UNDERWENT TREATMENT OF A DESCENDING THORACIC AORTIC ANEURYSM WHEREBY FOUR CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESIS WERE IMPLANTED DISTAL TO THE BRACHIOCEPHALIC ARTERY IN ZONE 1. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2015, FOLLOW UP IMAGING SHOWED THE ANEURYSM MEASURED 71 MM. ON (B)(6) 2015, FOLLOW UP IMAGING IDENTIFIED A PROXIMAL TYPE I ENDOLEAK WITH ANEURYSM ENLARGEMENT TO 75 MM. ON (B)(6) 2015, AN ADDITIONAL AORTIC ENDOGRAFT (UNKNOWN TYPE) WAS IMPLANTED FOR TREATMENT OF THE ENDOLEAK. NO FURTHER ADVERSE EVENTS WERE REPORTED. (CAPTURED EVENT # (B)(4)) ON (B)(6) 2018 THE ANEURYSM MEASURED 8.4CM X 7.9CM. ON (B)(6) 2018 A TYPE II ENDOLEAK WITH THORACIC ANEURYSM ENLARGEMENT WAS IDENTIFIED. ADDITIONALLY A TYPE III ENDOLEAK, DESCRIBED AS COMPONENT DISCONNECTION WAS ALSO DISCOVERED. RELAYPLUS ENDOGRAFTS WERE USED TO TREAT THE ENDOLEAKS. THE COMPONENTS INVOLVED IN THE ENDOLEAKS WERE REQUESTED HOWEVER THEY WERE NOT IDENTIFIED.

    Patient problems: Aneurysm

    MAUDE report 8425680 ↗
  • InjuryDec 5, 2018Patient Device Interaction Problem; Patient Device Interaction Problem

    ON (B)(6) 2016, THIS PATIENT UNDERWENT ENDOVASCULAR REPAIR OF A DESCENDING THORACIC AORTIC ANEURYSM USING THREE CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESES. ON (B)(6) 2018, A TYPE II ENDOLEAK WAS IDENTIFIED. ON THE SAME DAY, EMBOLIZATION OF THE TYPE II ENDOLEAK WAS PERFORMED. THE ENDOLEAK WAS RESOLVED.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8134165 ↗
  • MalfunctionJul 13, 2018Material Separation; Material Separation

    ON (B)(6) 2018, THE PATIENT UNDERWENT ENDOVASCULAR REPAIR OF A THORACIC AORTIC DISSECTION USING A CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESIS. IT WAS REPORTED THAT AFTER THE GORE® TAG® THORACIC ENDOPROSTHESIS (TGU404020/17752645) WAS DEPLOYED, UPON RETRACTING THE DELIVERY CATHETER THE LEADING OLIVE MET RESISTANCE ON THE SHEATH. THE PHYSICIAN WAS UNAWARE THAT THE OLIVE TIP HAD SEPARATED AND ADVANCED A CATHETER ON THE GUIDEWIRE AND PUSHED THE OLIVE OFF THE GUIDEWIRE INTO THE PATIENT'S LEFT COMMON ILIAC ARTERY. THE PHYSICIAN CHOSE TO DEPLOY A STENT AND CAPTURE THE OLIVE BETWEEN THE LEFT COMMON ILIAC WALL AND THE STENT AND LEAVE IT IN THE PATIENT. THE PATIENT TOLERATED THE PROCEDURE.

    Patient problems: Device Embedded In Tissue or Plaque; Vascular Dissection

    MAUDE report 7687787 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P040043. One submission often covers many models, so check the product and lot details in each record.

  • Z-0291-2021 · Sep 9, 2020 · Open, Classified
    GORE TAG Conformable Thoracic Stent Graft with ACTIVE CONTROL System
  • Z-0290-2021 · Sep 9, 2020 · Open, Classified
    GORE TAG CONFORMABLE Thoracic Stent Graft with ACTIVE CONTROL System
  • Z-2052-2020 · Dec 17, 2019 · Terminated
    Conformable Thoracic Stent Graft, Rx only, Sterile EO - Product Usage: This device is intended for endovascular repair of lesions of the descending thoracic aorta.
  • Z-0048-2018 · Sep 25, 2017 · Terminated
    GORE TAG, THORACIC ENDOPROSTHESIS, CONFORMABLE. The GORE TAG Thoracic Endoprosthesis is intended for endovascular repair of all lesions of the descending thoracic aorta.
  • Z-1237-06 · Apr 28, 2006 · Terminated
    GORE TAG THORACIC ENDOPROSTHESIS System, Endovascular Graft, Aortic Aneurysm Treatment, Catalogue Number TG3415, 34mm x 15cm
  • Z-1236-06 · Apr 28, 2006 · Terminated
    GORE TAG THORACIC ENDOPROSTHESIS System, Endovascular Graft, Aortic Aneurysm Treatment, Catalogue Number TG3410, 34mm x 10cm

Other System, Endovascular Graft, Aortic Aneurysm Treatment devices

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Sources and updates

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