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GORE TAG Conformable Thoracic Stent Graft TGMR404015Recalls & reported problems

W. L. Gore & Associates, Inc. · CTAG CMDS 40MMX40MMX15CM 22Fr · Class 3 · Implant

All models of GORE TAG Conformable Thoracic Stent Graft (25)

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

Adverse event reports
14
Deaths reported
2
Injuries reported
9
Recalls naming it
0

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00733132646845), received between Sep 25, 2020 and May 21, 2026 — classified as 2 deaths, 9 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (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: 2 reportsMay 2024: 0 reportsJun 2024: 1 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 1 reportsJan 2025: 0 reportsFeb 2025: 1 reportsMar 2025: 1 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 1 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: 1 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520262
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Adverse Event Without Identified Device or Use Problem5
  • Patient-Device Incompatibility3
  • Device Endoleak2
  • Activation, Positioning or Separation Problem1
  • Device Dislodged or Dislocated1
  • Difficult or Delayed Positioning1
  • Migration1
  • Patient Device Interaction Problem1

Patient problems

  • Clinical Endoleak4
  • Aneurysm3
  • Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available3
  • Vascular Dissection2
  • Aortic dissection1
  • Cardiac Arrest1
  • No Clinical Signs, Symptoms or Conditions1
  • Paraplegia1

Recent adverse event reports

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

  • InjuryMay 21, 2026Device Endoleak

    THE PATIENT REFERENCED IN THIS EVENT FILE IS ENROLLED IN THE TGR 23-02 CLINICAL STUDY: ON (B)(6) 2024, A PATIENT WAS TREATED FOR A THORACIC AORTIC DISSECTION AND TYPE 1A ENDOLEAK USING GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM (CTAG) AND GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS (TBE). ON (B)(6) 2026, A PATIENT WAS TREATED FOR A REINTERVENTION OF A TYPE 1A ENDOLEAK ON THE TBE, AS WELL AS A TYPE III ENDOLEAK BETWEEN THE TBE AND THE CTAG FROM JUNE 2024. THE PATIENT TOLERATED THE PROCEDURE.

    Patient problems: Clinical Endoleak

    MAUDE report 25242288 ↗
  • DeathJul 18, 2025Patient-Device Incompatibility; Device Endoleak; Patient-Device Incompatibility; Device Endoleak

    THE FIELD SALES ASSOCIATE (FSA) REPORTED THE FOLLOWING TO GORE: ON (B)(6) 2025, THE PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE TO TREAT AN ANEURYSM UTILIZING THE GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE) AND THE GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM (CTAG) IN ZONE 6. IT WAS REPORTED THAT ALL TAMBE AND CTAG DEVICES WERE IMPLANTED PRIOR TO THE PATIENT HAVING CARDIAC ARREST. THE PHYSICIAN THEN ATTEMPTED TO ADVANCE A GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX) THROUGH THE LEFT SUBCLAVIAN ARTERY (LSA) WHEN THE PATIENT CODED. THE PHYSICIAN AND FSA DETERMINED THAT THE PATIENT MAY HAVE HAD A DISSECTION IN THE MID DESCENDING AORTA. THE PHYSICIAN STATED THAT THE DISSECTION WAS PROXIMAL TO THE CTAG BUT COULD NOT VISUALLY SEE FAR ENOUGH DOWN THE PROXIMAL DESCENDING AORTA TO MAKE A DETERMINATION AS TO EXACT LOCATION OF RETROGRADE TEAR. AT THIS TIME, THE CARDIAC TEAM WAS ACTIVATED, CARDIOPULMONARY RESUSCITATION (CPR) WAS INITIATED AND THE PATIENT WAS PLACED ON BYPASS. THE PHYSICIAN PERFORMED AN OPEN THORACOTOMY WITH TWO ARCH ANASTOMOSES. ONCE THE PATIENT CAME OFF BYPASS, THEY EXPIRED. AT THE TIME OF THE CARDIAC ARREST AND SUSP

    Patient problems: Clinical Endoleak; Vascular Dissection

    MAUDE report 22541066 ↗
  • InjuryMar 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    THE FOLLOWING DETAILS WERE REPORTED TO GORE: ON (B)(6) 2025, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR A ZONE 2 THORACIC ACUTE AORTIC DISSECTION UTILIZING GORE® TAG® THORACIC BRANCH ENDOPROSTHESES. IT WAS REPORTED THAT THE GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS (AORTIC COMPONENT) (TAC083415A/(B)(6)) WAS ADVANCED UP TO THE INTENDED LOCATION AND LINED UP. THE PRIMARY HANDLE DEPLOYMENT WAS DEPLOYED, AND THE VERY FIRST PROXIMAL SLEEVE UNZIPPED, HOWEVER THE REST DID NOT. ADDITIONALLY, IT WAS REPORTED THAT BOTH DEPLOYMENT STRINGS/LINES CAME ALL THE WAY OUT OF THE GRAFT. IT WAS REPORTED THAT THE DEPLOYMENT STRING/LINE FOR THE SECONDARY DEPLOYMENT WAS BELIEVED TO BROKEN. IT IS UNKNOWN IF IT BROKE AT THE PORTAL, OR AT THE DISTAL END OF THE GRAFT. THE PHYSICIAN CAREFULLY DRAGGED THE GRAFT THROUGH THE AORTA DOWN TO A 22FR GORE® DRYSEAL HYDRO FLEX INTRODUCER SHEATH (DSF2233/(B)(6) OR DSF2233/(B)(6) (DSF). THE PHYSICIAN WAS ABLE TO PULL THE DEVICE BACK INTO THE DSF (EXCEPT FOR THE PROXIMAL PORTION THAT HAD ALREADY BEEN DEPLOYED OPEN). IN DOING SO THE LEFT COMMON ILIAC ARTERY (LCIA) AND A PORTION OF THE EXTERNAL ILIAC ARTERY (LCEIA) SUFFERED A DISSECTION. NEXT, THE PHYSICIAN ADVANCED

    Patient problems: Vascular Dissection

    MAUDE report 21587698 ↗
  • InjuryFeb 3, 2025Patient-Device Incompatibility; Device Dislodged or Dislocated; Patient-Device Incompatibility; Device Dislodged or Dislocated

    ON (B)(6) 2022, PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE TO TREAT A DESCENDING THORACIC AORTA, UTILIZING GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM. ON (B)(6) 2025 PATIENT PRESENTED WITH A POSSIBLE PROXIMAL TYPE 1A ENDOLEAK ON A PREVIOUSLY PLACED CTAG DEVICE IMPLANT. A PROXIMAL ENDOLEAK AND A TYPE 3 ENDOLEAK WERE IDENTIFIED VIA ANGIOGRAM AT THE JUNCTION OF THE 2 PREVIOUSLY PLACED DEVICES (TGMR404020, L/S#: (B)(6); TGMR404015, L/S#: (B)(6) ). THE PHYSICIAN BELIEVES THE CAUSE OF THE PROXIMAL ENDOLEAK WAS DUE TO DISEASE PROGRESSION AS WELL AS ANGLED ANATOMY IN THE AORTIC ARCH. ON (B)(6) 2025, PATIENT UNDERWENT A REINTERVENTION TO TREAT THESE ENDOLEAKS. THE FOLLOWING DEVICE WAS TREATED AS A PROXIMAL EXTENSION TO EXTEND THE SEAL ZONE NEAR THE LEFT SUBCLAVIAN ARTERY: TGM454515, L/S#: (B)(6), (PROXIMAL) AND TGM454515, L/S#: (B)(6). BOTH ENDOLEAKS APPEARED TO RESOLVE AFTER IMPLANTATION OF DEVICES AND BALLOONING. THE PATIENT TOLERATED THE PROCEDURE AND NO FURTHER ISSUES WERE NOTED. NO PATIENT IMAGES ARE AVAILABLE.

    Patient problems: Clinical Endoleak

    MAUDE report 21293062 ↗
  • MalfunctionDec 5, 2024Difficult or Delayed Positioning; Difficult or Delayed Positioning

    ON (B)(6) 2024, DURING AN ENDOVASCULAR PROCEDURE FOR TREATMENT OF A ZONE 1 DISSECTION, DURING THE SECOND STAGE DEPLOYMENT OF A GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM, WE PULLED THE HANDLE AND THE DEPLOYMENT LINE CAME OUT BUT IT DID NOT DEPLOY THE DEVICE TO IT¿S FULL DIAMETER. AS WE WERE CONCERNED THE DEVICE WAS GONNA FALL, WE ENDED UP WIRING IT FROM THE OTHER SIDE AND THEN BALLOONING IT OPEN TO IT¿S FULL DIAMETER. IT ENDED UP WORKING, HOWEVER THE DEVICE WAS NOT LANDED WHERE INTENDED AND WE IMPLANTED AN ADDITIONAL DEVICE TO ADD COVERAGE AS ORIGINALLY INTENDED. THERE WAS NO UNINTENTIONAL COVERAGE OF ANY BRANCH VESSELS AND NO ADVERSE EVENT TO THE PATIENT. THE PATIENT TOLERATED THE PROCEDURE.

    Patient problems: Aortic dissection

    MAUDE report 20855028 ↗
  • MalfunctionJun 3, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

    THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2024, THE PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE IN ZONE 4 DESCENDING AORTA TO TREAT A THORACIC AORTIC ANEURYSM UTILIZING A GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM (CTAGAC). REPORTEDLY, THE ANATOMY WAS EXTREMELY TORTUOUS. THE FIRST CTAGAC DEPLOYMENT WENT GREAT. AFTER, THE PHYSICIAN WENT TO BRIDGE IT PROXIMALLY WITH ANOTHER CTAGAC, THE 3RD DEPLOYMENT LINE (LOCKWIRE) BROKE BECAUSE OF THE TORTUOUS ANATOMY (ANGULATED AORTA) AND THE DEVICE HAD TO BE FORCED UP INTO THE AORTA TO WHERE THE PHYSICIAN WANTED TO LAND AT THE INTENDED LOCATION, HOWEVER, THE PHYSICIAN WAS ABLE TO DEPLOY THE DEVICE BY PULLING LINE 3 VIA THE DEPLOYMENT HATCH THAT DISENGAGED THE LOCKWIRE AND DEPLOYMENT WAS COMPLETED SUCCESSFULLY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19446908 ↗
  • InjuryApr 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2023, THE PATIENT UNDERWENT AN ENDOVASCULAR TREATMENT OF A THORACIC AORTIC DISSECTION USING GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM. THE PATIENT TOLERATED THE PROCEDURE. IT WAS REPORTED THAT ON (B)(6) 2024, THE PHYSICIAN PERFORMED A REINTERVENTION TO TREAT A SMALL FENESTRATION STILL FILLING THE FALSE LUMEN. THE SMALL FENESTRATION WAS IN THE TREATMENT AREA, JUST DISTAL (APPROXIMATELY 2CM DISTAL) TO THE IMPLANTED GRAFT. THE PHYSICIAN IMPLANTED AN ADDITIONAL GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM DISTALLY TO COVER THE FENESTRATION. THE PATIENT TOLERATED THE PROCEDURE.

    Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

    MAUDE report 19034328 ↗
  • DeathApr 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    ON (B)(6) 2024, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN EXPANDING PENETRATING AORTIC ULCER DISTAL TO THE LEFT SUBCLAVIAN ARTERY. A GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS (TBE) AORTIC COMPONENT (TAC083715A), TBE SIDE BRANCH COMPONENT (TSB081206A), AND GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM (TGMR404015) WERE IMPLANTED. THE PROCEDURE WAS REPORTED AS ON LABEL AND PERFORMED PER THE DEVICES' INSTRUCTIONS FOR USE. THERE WERE NO REPORTED ISSUES DURING THE PROCEDURE AND THE PATIENT TOLERATED THE PROCEDURE. APPROXIMATELY TWO HOURS POST-OPERATIVELY, THE PATIENT REPORTEDLY CODED. THE PATIENT WAS BROUGHT BACK TO THE OPERATING ROOM WHERE THE TEAM PERFORMED COMPRESSIONS AND RESUSCITATIVE MEASURES FOR APPROXIMATELY ONE HOUR. THERE WAS NO REPORTED RUPTURE OR OTHER ISSUE OBSERVED RELATED TO THE DEVICE IMPLANT. THE PATIENT REPORTEDLY EXPIRED. THE CAUSE OF THE PATIENT DEATH REMAINS UNKNOWN.

    Patient problems: Cardiac Arrest; Respiratory Arrest

    MAUDE report 19014783 ↗
  • InjuryDec 14, 2022Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

    ON (B)(6) 2022, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF A THORACIC AORTIC ANEURYSM WITH GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM (CTAG-AC)-MOST ADJACENT TO THE TBE AORTIC COMPONENT. TREATMENT AREA WAS ZONE 0-PROXIMAL TO THE BRACHIOCEPHALIC TRUNK, DISTAL TO THE SINOTUBULAR JUNCTION. ON (B)(6) 2021, THE PRE-TREATMENT COMPUTED TOMOGRAPHY (CT) IMAGING SHOWED THAT THE MAXIMUM DIAMETER OF THE AORTIC ANEURYSM WAS 58MM. IT WAS REPORTED THAT ON (B)(6) 2022, A FOLLOW UP CT REVEALED A TYPE II ENDOLEAK FROM THE LEFT SUBCLAVIAN ARTERY. THE MAXIMUM DIAMETER OF THE AORTIC ANEURYSM WAS 54MM. THE EVENT WAS ONGOING. THE PHYSICIAN WAS MONITORING THE PATIENT. ON (B)(6) 2022, THE MAXIMUM DIAMETER OF THE AORTIC ANEURYSM WAS 57MM. ON (B)(6) 2022, A PERSISTENT TYPE II ENDOLEAK WAS NOTED. ACCORDING TO THE SITE, IT WAS RELATED WITH THE ENDOVASCULAR PROCEDURE. THE PATIENT UNDERWENT AN EMBOLIZATION PROCEDURE.

    Patient problems: Aneurysm; Clinical Endoleak

    MAUDE report 15984016 ↗
  • InjuryAug 22, 2022Patient Device Interaction Problem; Patient Device Interaction Problem

    ON (B)(6) 2022, THE PATIENT WAS TREATED FOR A THORACIC AORTIC ANEURYSM. A PREVIOUS SURGERY HAD BEEN PERFORMED TO DO A LEFT SUBCLAVIAN-LEFT CAROTID BYPASS. THE SURGERY TO TREAT THE ANEURYSM WAS INTENDED TO COVER THE LEFT SUBCLAVIAN ARTERY, SO IMAGING WAS PERFORMED PRIOR TO THE SURGERY. IT WAS NOTED THAT THE BYPASS DID NOT INCLUDE THE LEFT VERTEBRAL ARTERY. THE PHYSICIAN CONSULTED WITH A NEUROLOGIST TO DETERMINE IF THE SURGERY COULD BE PERFORMED AS PLANNED, OR IF BLOOD FLOW WOULD BE COMPROMISED WITH THE INTENDED PLACEMENT OF THE GRAFT. THE NEUROLOGIST FELT THAT THE SURGERY COULD PROCEED. SURGERY WAS PERFORMED AS PLANNED, BUT AFTER THE PROCEDURE, IT WAS DISCOVERED THAT THE PATIENT SUFFERED OCCIPITAL BLINDNESS.

    Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

    MAUDE report 15266839 ↗
  • MalfunctionMar 8, 2022Migration; Migration

    ON (B)(6) 2021, THE PATIENT WAS IMPLANTED WITH TWO GORE® TAG® CONFORMABLE THORACIC ENDOPROSTHESES (TGMR404015, TGMR404020). AS REPORTED, THE IMPLANTATION WAS ORIGINALLY TAKEN TO THE LEFT SUBCLAVIAN ARTERY (LSA) COVERING A PRIMARY ENTRY TEAR AND THE DISSECTION BEING TREATED HAD AN ANEURYSMAL COMPONENT NOT FAR FROM THE PRIMARY ENTRY TEAR. IT IS UNCLEAR WHICH OF THE TWO DEVICES WAS IMPLANTED PROXIMALLY. ON (B)(6) 2021 IMAGING CONFIRMED THAT THE DEVICE WAS POSITIONED PROPERLY AND THERE WAS NO OBSERVED EVIDENCE OF MIGRATION. ON (B)(6) 2022 IMAGING REVELED THAT THE DEVICE HAD MIGRATED DISTALLY 2CM ON THE OUTER CURVATURE OF THE AORTA. AS REPORTED BY THE TREATING FACILITY, "BESIDES NEW ANTEGRADE FILLING IN THE LEFT SUBCLAVIAN (WHICH WAS PREVIOUSLY COVERED), THERE HAS BEEN NO PROGRESSION OF DISEASE AND THE TWO CTS ARE OTHERWISE STABLE". ALSO, ACCORDING TO THE TREATING FACILITY: THE LANDING ZONE IN NORMAL AORTA (FROM LEFT CAROTID TO ENTRY TEAR) WAS 10.1MM. DIAMETER OF THE AORTA AT THIS LOCATION WAS 28-32MM AVERAGE. ANATOMY WAS CONFIRMED WITH INTRAOPERATIVE IVUS. DIMENSIONAL ANALYSIS REPORTED AS PART OF THE INVESTIGATION WAS TAKEN FROM CTA IMAGING. THERE ARE NO PLANS TO INTERVENE AT THIS TIME

    Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

    MAUDE report 13698738 ↗
  • InjuryOct 5, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    ON (B)(6) 2021 THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF A PENETRATING AORTIC ULCER WITH A CHRONIC DISSECTION USING A GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM, A GORE® EXCLUDER® AAA TRUNK-IPSILATERAL LEG COMPONENT, AND A GORE® EXCLUDER® AAA CONTRALATERAL LEG COMPONENT. THE PROCEDURE WAS A COMBINED TEVAR AND EVAR PROCEDURE. IT WAS REPORTED THAT THE PATIENT HAD MULTIPLE COMORBIDITIES. THERE WERE NO REPORTED ISSUES WITH DEVICE PLACEMENT. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2021 THE PHYSICIAN INFORMED THE FIELD SALES ASSOCIATE THAT THE PATIENT EXPERIENCED PARAPLEGIA ABOUT TWO HOURS AFTER THE PROCEDURE. REPORTEDLY THE CAUSE OF PARAPLEGIA IS UNKNOWN. A SPINAL DRAIN WAS PLACED. THE PATIENT IS BEING MONITORED.

    Patient problems: Paraplegia

    MAUDE report 12580496 ↗
  • InjuryNov 12, 2020Positioning Failure; Positioning Failure

    ON (B)(6) 2020, THIS PATIENT UNDERWENT TREATMENT FOR A DESCENDING THORACIC AORTIC ANEURYSM AND WAS IMPLANTED WITH GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2020, THE PATIENT UNDERWENT REINTERVENTION FOR TREATMENT OF A PROXIMAL TYPE I ENDOLEAK AND WAS IMPLANTED WITH AN ADDITIONAL GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM. THE TREATMENT PLAN WAS TO EXTEND SEAL AND COVERAGE PROXIMALLY TO THE LEFT COMMON CAROTID ARTERY(LCCA). THE DEVICE WAS LOADED ONTO THE LUNDERQUIST WIRE AND ADVANCED TO THE AORTIC ARCH WITHOUT ISSUE AND ADVANCED PROXIMAL TO TARGET LANDING ZONE, AND THEN REPOSITIONED TO TARGET DEPLOYMENT LOCATION. THE FIRST STAGE OF DEPLOYMENT WAS COMPLETED; THE STRING WAS FULLY REMOVED AND THE DEVICE OPENED TO 50% PROXIMALLY FOR THE FIRST 2CM THEN WAS CONSTRAINED AND THEN OPENED UP AGAIN DISTALLY. THE SECOND STAGE DEPLOYMENT WAS THEN COMPLETED SUCCESSFULLY, BUT THE MID SEGMENT OF THE GRAFT STILL DID NOT OPEN UP. NEUROMONITORING SAID PRESSURES HAD THEN DROPPED IN THE FEMORALS, SO AN ANGIO WAS DONE TO SHOW THE CONSTRAINED SEGMENT OF THE GRAFT. A GORE® TRI-LOBE BALLOON CATHETER WAS

    Patient problems: Aneurysm

    MAUDE report 10830674 ↗
  • InjurySep 25, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    ON (B)(6) 2020, THE PATIENT WAS IMPLANTED WITH CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESIS WITH ACTIVE CONTROL SYSTEM TO TREAT A RUPTURED THORACIC AORTIC ANEURYSM. IT WAS REPORTED THE PATIENT PRESENTED EMERGENTLY, SEVERAL COOK THORACIC ENDOPROSTHESES WERE IMPLANTED AND A CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESIS WITH ACTIVE CONTROL SYSTEM (TGMR404015/21875918). THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2020, THE PATIENT BECAME UNSTABLE AND A DISTAL TYPE I ENDOLEAK WAS REVEALED. THE PHYSICIAN REINTERVENED AND IMPLANTED AN ADDITIONAL CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESIS WITH ACTIVE CONTROL SYSTEM. THE PATIENT TOLERATED THE REINTERVENTION AND THE ENDOLEAK WAS RESOLVED.

    Patient problems: Aneurysm

    MAUDE report 10588447 ↗

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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