GORE TAG Conformable Thoracic Stent Graft TGMR373710Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00733132646807), received between Dec 26, 2019 and May 7, 2026 — classified as 2 deaths, 7 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (2 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.

Most reported problems

Recent adverse event reports

The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• DeathMay 7, 2026Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING WAS REPORTED: ON (B)(6) 2026, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF A THORACOABDOMINAL AORTIC ANEURYSM. THE PATIENT WAS TREATED WITH A GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE). IT WAS REPORTED THAT THREE OF THE FOUR VISCERAL VESSELS WERE DEPLOYED, WHEN THE PHYSICIAN WAS AT THE FINAL STAGE OF DEPLOYING THE TAMBE DEVICE, THEY NOTICED THE PROXIMAL END OF THE DEVICE HAD PULSATILE MOVEMENT. IVIS WAS DONE AND DETERMINED THERE WAS A RETROGRADE DISSECTION. THE DISSECTION STARTED FROM THE TOP OF THE TAMBE GRAFT (LANDED APPROXIMATELY 65CM ABOVE CELIAC ARTERY) AND WENT INTO THE ASCENDING THORACIC AORTA. THERE WAS NO PRE-EXISTING DISSECTION. THE PATIENT WAS TAKEN TO A DIFFERENT HOSPITAL, AND AN OPEN REPAIR WAS DONE. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2026, A FOLLOW UP CT REVEALED THE FALSE LUMEN WAS STILL PRESSURIZED. A REINTERVENTION OCCURRED, AND A GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM WAS IMPLANTED. THE LEFT SUBCLAVIAN ARTERY WAS COVERED AND PLANNED; THIS WAS A STAGED SURGERY. THERE WAS A PLAN TO PERFORM A BYPASS SURGERY OF THE LEFT SUBCLAVIAN ARTERY ON A DIFFERENT DATE. THE PATIENT TOLERATED THE PROC

  Patient problems: Vascular Dissection

  MAUDE report 25115814 ↗
• InjuryFeb 16, 2026Device Endoleak

  THE FIELD SALES ASSOCIATE (FSA) REPORTED THE FOLLOWING TO GORE: ON (B)(6) 2024, THE PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE TO TREAT A DISSECTION UTILIZING THE GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS IN ZONE 2. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2025, THE PATIENT UNDERWENT A REINTERVENTION PROCEDURE TO ADDRESS A TYPE 1A ENDOLEAK (B)(4). THE PHYSICIAN IMPLANTED A GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM ALONG WITH A GORE® VIABAHN® ENDOPROSTHESIS TO RESOLVE THE ENDOLEAK. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2026, THE FSA WAS INFORMED THAT THE TYPE 1A ENDOLEAK PERSISTED. ON (B)(6) 2026, THE PHYSICIAN IMPLANTED THE GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS AORTIC EXTENDER TO RESOLVE ENDOLEAK. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Clinical Endoleak

  MAUDE report 24349645 ↗
• InjuryDec 16, 2025Obstruction of Flow; Appropriate Device Problem Term/Code Not Available; Patient Device Interaction Problem; Obstruction of Flow; Appropriate Device Problem Term/Code Not Available; Patient Device Interaction Problem

  THE FOLLOWING INFORMATION WAS REPORTED THROUGH THE AAA 24-01 TAMBE POST APPROVAL STUDY: ON (B)(6) 2025, THE PATIENT UNDERWENT ENDOVASCULAR PROCEDURE TO TREAT A THORACOABDOMINAL ANEURYSM IV USING A GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE) DEVICE SYSTEM. ALSO, WERE IMPLANTED A GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM, A GORE® EXCLUDER® AAA ENDOPROSTHESIS DEVICE AND A GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS DEVICE. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2025, IT WAS REPORTED, THE PATIENT HAD A SPINAL CORD ISCHEMIA WITH FLACCID PARALYSIS OF THE LOWER EXTREMITY. THE PATIENT HAD MINOR MOTOR DEFICIT, ABLE TO WALK WITH ASSISTANCE OR INDEPENDENTLY (IMPLIES THE ABILITY TO MOVE AGAINST GRAVITY). ACCORDING TO THE SITE, IT WAS NOT RELATED TO THE DEVICES, PROCEDURE OR DISEASE. ON (B)(6) 2025, THE PATIENT HAD A RECUSE MANEUVERS TREATMENT. ON (B)(6) 2025, THE PATIENT DISCHARGED HOME. THE PHYSICIAN IS MONITORING THE PATIENT.

  Patient problems: Ischemia; Movement Disorder; Paralysis

  MAUDE report 23819240 ↗
• MalfunctionJan 17, 2025Entrapment of Device; Entrapment of Device

  ON (B)(6) 2025, THIS PATIENT UNDERWENT OPEN REPAIR FOR A DISSECTION WITH A GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM. IT WAS REPORTED THAT THE DEVICE WAS LOADED ON TO A MEIER¿ GUIDEWIRE AND ADVANCED UP THE PATIENT¿S OPEN CHEST UP TO THE DESCENDING THORACIC AORTA TO THE LEVEL OF THE LEFT SUBCLAVIAN ARTERY AND DEPLOYED TO FULL DIAMETER. IT WAS REPORTED THAT THE PHYSICIAN WENT TO REMOVE THE REST OF THE DELIVERY SYSTEM THE LINE TO PULL THE ANGULATION WIRE HAD POPPED OFF. THE RED LOCK WIRE HANDLE WAS ROTATED AND WHEN PULLED BACK IT FAILED TO REMOVE THE ANGULATION FIBERS. THE PHYSICIAN REPORTED HE WAS UNABLE TO GET THE DEVICE TO RELEASE OFF THE CATHETER, SO THEY JUST SLID IT RIGHT BACK OUT. THE DEVICE WAS DISCARDED AT THE SITE. THERE WAS NO BLOOD LOSS OR HARM TO THE PATIENT REPORTED. THE PROCEDURE WAS CONCLUDED WITH NO GORE DEVICES IMPLANTED. THE PATIENT IS REPORTED TO BE DOING WELL AND HAS ALREADY BEEN DISCHARGED TO HOME. AS THIS PROCEDURE WAS OFF LABEL AND NOT SUPPORTED BY GORE, THE FIELD SALES ASSOCIATE FOR THE ACCOUNT CONTACTED THE PHYSICIAN TO CONFIRM IF THE BACK-UP HATCH MECHANISM HAD BEEN UTILIZED; AND WAS TOLD IT HAD NOT BEEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21181924 ↗
• InjuryDec 10, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  THE FSA (FIELD SALES ASSOCIATE) REPORTED THE FOLLOWING TO GORE: ON (B)(6) 2024, THE PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE TO TREAT AN ANEURYSM UTILIZING THE GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM, GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS (AORTIC AND SIDE BRANCH COMPONENT) AND GORE® TRI-LOBE BALLOON CATHETER IN ZONE 2. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2024, IT WAS REPORTED THAT THE PATIENT EXPERIENCED A STROKE WHICH LEAD TO THE PATIENT EXPERIENCING BLINDNESS. THE PATIENT HAD A NEUROLOGY CONSULT AND THE NEUROLOGIST STATED THERE WAS NOTHING TO RE-INTERVENE ON. THE PATIENT IS BEING MONITORED. THE PHYSICIAN DOES NOT KNOW WHAT CAUSED THE REPORTED EVENT TO OCCUR.

  Patient problems: Ischemia Stroke

  MAUDE report 20892711 ↗
• InjuryJul 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO GORE THAT ON (B)(6) 2024, A PATIENT WAS IMPLANTED WITH GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM (CTAG/AC) TO TREAT ASCENDING AORTIC ANEURYSM. THE PATIENT HAD ASCENDING AORTIC ANEURYSM AND PERFORMED A HEART TRANSPLANT PREVIOUSLY. DURING THE PROCEDURE, A TGMR373710 CTAG/AC WAS IMPLANTED AND DEPLOYED AS PLANNED. DUE TO THE LARGE SIZE OF THE ANEURYSM, THE STENT MOVED BACKWARDS AFTER IMPLANTATION. THERE IS NO COVERAGE OF BRANCH VESSEL. THE PHYSICIAN CONTINUED TO IMPLANT ANOTHER CTAG/ACS (TGMR404010) AND CTAG (TGU4545110) TO RELINE THE TGMR373710. THE PATIENT TOLERATED THE PROCEDURE AND TRANSFERRED TO ICU FOR MONITOR. ON (B)(6) 2024, CLINICIAN FEEDBACKED THAT THE PATIENT HAD CEREBRAL INFARCTION. THE PHYSICIAN SUSPECTED IT MAY RELATE TO PATIENT'S CONDITION, NOT TO THE PRODUCT.

  Patient problems: Neurogenic Shock

  MAUDE report 19835605 ↗
• MalfunctionMay 20, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ON (B)(6) 2024, THE PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE IN ZONE 4 - DESCENDING AORTA TO TREAT A DISSECTION UTILIZING GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM ENDOPROSTHESES (TGMR373710 AND TGMR373715), A GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS AORTIC COMPONENT AND GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS SIDE BRANCH. IT WAS REPORTED THAT AFTER COMPLETION OF THE THORACIC BRANCH ENDOPROSTHESIS A CTAG TGMR373710 WAS PLACED IN THE DESCENDING AORTA. THE PHYSICIAN DEPLOYED FAIRLY QUICKLY (QUICKER THAN NORMAL) AND AFTER FULLY DEPLOYING THE DEVICE, THE CATHETER DID NOT WANT TO RETRIEVE OUT. IT APPEARED SNAGGED ON SOMETHING. THE PHYSICIAN CONTINUED TO TRY TO BRING THE CATHETER OUT AND FINALLY IT DID COME OUT BUT THE OLIVE STAYED IN THE PATIENT AT THE SAME PLACE AS THE CTAG, IT DID NOT MOVE. THE PHYSICIAN THEN PLACED CTAG TGMR373715 OVER THE DEVICE IN ORDER TO TRAP THE OLIVE AGAINST THE CTAG TGMR373710. THE PATIENT TOLERATED THE PROCEDURE. THE PHYSICIAN DOES NOT KNOW WHAT CAUSED THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19350786 ↗
• MalfunctionFeb 14, 2024Defective Device; Defective Device

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2023, THE PATIENT UNDERWENT AN EMERGENT PROCEDURE TO TREAT AN AORTIC DISSECTION UTILIZING A GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM. REPORTEDLY, THE DEVICE FAILED TO DEPLOY WHEN THEY PULLED THE HANDLE AT THE FIRST DEPLOYMENT, IT FAILED TO OPEN AND PHYSICIAN DOES NOT KNOW WHY IT DID NOT WORK. THEY THEN TRIED TO DEPLOY THE DEVICE BY OPENING THE BACKUP HATCH BUT BY THEN THE PATIENT HEALTH'S STARTED TO DECLINE REALLY FAST AS PATIENT WAS ON CARDIAC CIRCULATION DURING THE PROCEDURE, SO THE PHYSICIAN ABORTED USING THE DEVICE ALL TOGETHER AS THEY DID NOT WANT TO WASTE TIME TO USE THE HATCH DUE TO PATIENT'S DECLINING CONDITION. PATIENT WAS STABILIZED THEN TAKEN TO ICU, NO FURTHER INFORMATION AVAILABLE ON THE CASE. FSA WAS NOT INVOLVED IN THIS CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18704398 ↗
• InjuryJan 11, 2024Improper or Incorrect Procedure or Method; Malposition of Device; Patient-Device Incompatibility; Improper or Incorrect Procedure or Method; Malposition of Device; Patient-Device Incompatibility

  ON (B)(6) 2023, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF A THORACIC AORTIC DISSECTION USING GORE® TAG® THORACIC BRANCH ENDOPROSTHESES (TBE). A THORACIC AORTIC COMPONENT AND A SIDE BRANCH COMPONENT WERE IMPLANTED. A PROXIMAL TYPE I ENDOLEAK WAS OBSERVED ON THE AORTIC COMPONENT, SO AN AORTIC EXTENDER COMPONENT WAS IMPLANTED TO TREAT THE ENDOLEAK. THE ENDOLEAK REMAINED, SO THE PHYSICIAN OPTED TO RELINE THE TBE SYSTEM WITH A GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM (CTAG A/C). THE SIDE BRANCH PORTAL WAS INTENTIONALLY COVERED AND A VBX DEVICE WAS USED TO EXTEND FROM THE PORTAL DISTALLY IN A PERISCOPE TECHNIQUE. IT WAS NOTED THAT THE DISTAL END OF THE VBX DEVICE WAS ALIGNED WITH THE DISTAL END OF THE CTAG A/C DEVICE. ON (B)(6) 2023, FOLLOW-UP CT IMAGING REVEALED A TYPE I ENDOLEAK AND SUSPECTED GUTTER LEAK FROM THE VBX AND CTAG A/C DEVICE. ON (B)(6) 2023, THE PATIENT UNDERWENT REINTERVENTION OF THE ENDOLEAKS. AN ADDITIONAL CTAG A/C WAS IMPLANTED. IT WAS REPORTED THAT THE DISTAL END OF THE NEWLY IMPLANTED CTAG A/C DEVICE EXTENDED PASSED THE INITIAL CTAG A/C DEVICE. THE TYPE I ENDOLEAK AND GUTTER LEAK WERE RESOLVED.

  Patient problems: Clinical Endoleak; Obstruction/Occlusion

  MAUDE report 18496522 ↗
• InjurySep 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2023, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF A THORACOABDOMINAL AORTIC ANEURYSM USING A GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE) AND A GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM IN THE AAA1701 TAMBE PIVOTAL STUDY. ON (B)(6) 2023, A PSEUDOANEURYSM WAS REPORTED IN THE PATIENT'S THORACIC AORTA. UPON FOLLOW-UP WITH THE SITE IT WAS CONFIRMED THAT THE SMALL, SACCULAR, PROXIMAL PSEUDOANEURYSM WAS PRE-EXISTING IN NATURE AND WAS LEFT UNTREATED AT THE TIME OF THE INDEX PROCEDURE TO REDUCE THE RISK OF SPINAL ISCHEMIA. THE PHYSICIAN REPORTED THAT THE ANEURYSM IS TOO SMALL TO CARRY ANY RISK OF RUPTURE, AND THUS REMAINS UNTREATED. THE PRE-EXISTING PROXIMAL PSEUDOANEURYSM WILL CONTINUE TO BE MONITORED BY THE SITE.

  Patient problems: Pseudoaneurysm

  MAUDE report 17702398 ↗
• DeathOct 30, 2022Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  ON (B)(6) 2019, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN UNKNOWN ETIOLOGY. A POSITION MODIFIED ENDOGRAFT WAS PLACED IN THE PATIENT'S AORTA AND AN ICAST BALLOON-EXPANDABLE COVERED STENT GRAFT WAS USED IN THE PATIENT'S RENAL ARTERY. A GORE® EXCLUDER® ILIAC BRANCH COMPONENT (IBE) WAS PLACED DISTALLY IN THE PATIENT'S LEFT COMMON ILIAC ARTERY AND AN ADDITIONAL NON-GORE CUFF DEVICE WAS USED AS A BRIDGING STENT. IT WAS NOTED THAT MULTIPLE GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESES AND A MEDTRONIC ENDURANT AORTIC CUFF WERE ALSO USED. THE PATIENT'S ANATOMY WAS REPORTEDLY EXTREMELY TORTUOUS. ON (B)(6) 2022, REINTERVENTION WAS PERFORMED TO TREAT TWO TYPE III ENDOLEAKS. THE FIRST ENDOLEAK WAS REPORTED BETWEEN THE NON-GORE AORTIC ENDOGRAFT AND THE ICAST DEVICE IN THE PATIENT'S RENAL ARTERY. THE SECOND TYPE III ENDOLEAK WAS REPORTED BETWEEN THE IBE DEVICE AND THE NON-GORE CUFF THAT WERE PLACED DISTALLY IN THE PATIENT'S LEFT COMMON ILIAC ARTERY. A PROXIMAL TYPE I ENDOLEAK WAS ALSO OBSERVED ON THE NON-GORE ENDOGRAFT. IT WAS REPORTED THAT A GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM WAS ADVANCED IN AN ATTEMPT TO TREAT THE PROXIMAL TYPE I ENDOLEAK. REP

  Patient problems: Insufficient Information

  MAUDE report 15697571 ↗
• MalfunctionJan 28, 2022Separation Failure; Separation Failure

  ON (B)(6) 2022, THE PATIENT WAS TREATED FOR A THORACIC AORTIC ANEURYSM. THE PHYSICIAN USED AN ELEPHANT TRUNK TECHNIQUE USING A GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM. THE DEVICE WAS DEPLOYED, BUT WAS UNABLE TO BE REMOVED FROM THE CATHETER - (1600-E, CATHETER EVENTS - OTHER/UNKNOWN). THE LOCK WOULD NOT RELEASE, AND THE PHYSICIAN WAS UNAWARE OF THE ABILITY TO USE THE ESCAPE HATCH TO RESOLVE THE ISSUE, SO HE DECIDED TO USE A DIFFERENT GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM. THE PATIENT TOLERATED THE PROCEDURE. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13386103 ↗
• InjuryDec 1, 2021Patient Device Interaction Problem; Patient Device Interaction Problem

  ON (B)(6) 2021 THE PATIENT UNDERWENT STAGE 1 TREATMENT OF A THORACOABDOMINAL AORTIC ANEURYSM WITHOUT RUPTURE IN THE (B)(6) THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE) CLINICAL TRIAL. A CONFORMABLE (B)(6) ENDOPROSTHESIS (CTAG) WAS IMPLANTED. ON (B)(6) 2021 THE PATIENT UNDERWENT STAGE 2 TREATMENT WITH THE TAMBE INVESTIGATIONAL DEVICE. ON (B)(6) 2021 A TYPE B AORTIC DISSECTION WAS OBSERVED AND ON (B)(6) 2021 THE DISSECTION WAS TREATED BY MEANS OF A LEFT CAROTID SUBCLAVIAN BYPASS AND IMPLANTATION OF A (B)(6) CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM (CTAG A/C) PROXIMAL TO THE ORIGINALLY PLACED CTAG DEVICE. ON (B)(6) 2021 X-RAY EXAMINATION REVEALED A TYPE II ENDOLEAK ORIGINATING FROM THE PATIENT'S LEFT SUBCLAVIAN ARTERY WHERE THE CTAG A/C DEVICE WAS LOCATED. ON (B)(6) 2021 A REINTERVENTION WAS PERFORMED WHEREBY EMBOLIZATION OF THE PATIENT'S LEFT SUBCLAVIAN ARTERY PROXIMAL TO THE LEFT VERTEBRAL ARTERY ORIGIN WAS PERFORMED VIA LEFT BRACHIAL ARTERY ACCESS. EMBOLIZATION WAS PERFORMED USING COOK MEDICAL NESTER® EMBOLIZATION COILS AND A MEDTRONIC MVP MICRO VASCULAR PLUG. IT WAS REPORTED THAT THE COMPLETION ANGIOGRAM DEMONSTRATED SIGNIFICANT IMPROVEMENT OF THE TYPE II ENDO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12912379 ↗
• MalfunctionOct 4, 2021Fracture; Fracture

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2021 A PATIENT UNDERWENT STAGE 1 TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM IN THE (B)(6) CLINICAL TRIAL. A CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESIS (CTAG) WAS IMPLANTED. ON (B)(6) 2021 A TYPE B AORTIC DISSECTION WAS OBSERVED. ON (B)(6) 2021 THE DISSECTION WAS TREATED BY MEANS OF A LEFT CAROTID SUBCLAVIAN BYPASS AND IMPLANTATION OF A CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESIS PROXIMAL TO THE ORIGINALLY PLACED CTAG. DISSECTION CAPTURED IN CASE (B)(4). ON (B)(6) 2021 X-RAY EXAMINATION REVEALED A WIRE FRACTURE AT THE PROXIMAL END OF THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12573609 ↗
• MalfunctionDec 26, 2019Activation Failure; Activation Failure

  THE GORE® TAG® CONFORMABLE THORACIC STENT GRAFTS WITH ACTIVE CONTROL SYSTEM WERE USED TO TREAT AN ABDOMINAL AORTIC ANEURYSM, AND NOT A THORACIC AORTIC ANEURYSM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9521538 ↗

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-0290-2021 · Sep 9, 2020 · Open, Classified
  GORE TAG CONFORMABLE Thoracic Stent Graft with ACTIVE CONTROL System
• Z-0291-2021 · 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