GORE TAG Conformable Thoracic Stent Graft TGMR373715Recalls & reported problems

Summary

The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 00733132646814), received between Nov 15, 2019 and Jun 9, 2026 — classified as 2 deaths, 26 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (6 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 25 most recent of 32 reports, in the reporter's own words as published by the FDA.

• InjuryJun 9, 2026Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6), 2026, THE PATIENT UNDERWENT ENDOVASCULAR REPAIR OF AN AORTIC ANEURYSM USING GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM (CTAG) IN COMBINATION WITH THE GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE). IT WAS REPORTED THAT THE PROCEDURAL PLAN INITIALLY INCLUDED CONSIDERATION OF THORACIC REPAIR ALONE; HOWEVER, THE TREATING TEAM ELECTED TO PROCEED WITH THORACOABDOMINAL REPAIR USING THE TAMBE SYSTEM. CTAG DEVICES WERE IMPLANTED IN THE THORACIC AORTA, FOLLOWED BY DEPLOYMENT OF THE TAMBE AORTIC COMPONENT AND GORE® EXCLUDER® ILIAC BRANCH AND CONTRALATERAL LEG COMPONENTS. SPECIFIC GORE® VIABAHN® VBX IMPLANT DETAILS WERE NOT AVAILABLE AT THE TIME OF REPORTING. THE PROCEDURE REPORTEDLY PROGRESSED WITHOUT TECHNICAL COMPLICATIONS. NEAR THE CONCLUSION OF THE PROCEDURE, AN INTRAOPERATIVE PRESSURE TEST WAS PERFORMED TO SIMULATE THE IMPACT OF LUMBAR ARTERY COVERAGE. NEUROMONITORING WAS ASSESSED DURING THIS PERIOD, AND NO CHANGES WERE OBSERVED. BASED ON THESE NEUROMONITORING FINDINGS, THE PHYSICIAN PROCEEDED WITH COMPLETION OF THE LEFT ILIAC LIMB. IT WAS REPORTED THAT DURING THE PROCEDURE THE PATIENT EXPERIENCED

  Patient problems: Ischemia Stroke; Paresis

  MAUDE report 25449456 ↗
• InjuryMar 2, 2026Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE THROUGH THE PIVOTAL STUDY FOR THE GORE® ASCENDING STENT GRAFT IN THE TREATMENT OF LESIONS OF THE ASCENDING AORTA (ASG DEVICE): ON (B)(6) 2026, THE PATIENT WAS IMPLANTED WITH GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM AND GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS (TBE AORTIC COMPONENT AND SIDE BRANCH) TO TREAT A THORACIC ANEURYSM. THE PATIENT TOLERATED THE PROCEDURE. IT WAS REPORTED THAT POST PROCEDURE ON (B)(6) 2026, THE PATIENT HAD A STROKE DUE TO A HIGHLY CALCIFIED AORTIC ARCH. THE PATIENT WAS TREATED WITH LOW NOMOGRAM HEPARIN.

  Patient problems: Ischemia Stroke

  MAUDE report 24484958 ↗
• InjuryFeb 3, 2026Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE THROUGH THE PIVOTAL STUDY FOR THE GORE® ASCENDING STENT GRAFT IN THE TREATMENT OF LESIONS OF THE ASCENDING AORTA (ASG DEVICE): ON (B)(6) 2026, THE PATIENT WAS IMPLANTED WITH GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS (TBE) AND GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM (CTAGAC) TO TREAT AN ASCENDING AORTIC ANEURYSM. THE PATIENT TOLERATED THE PROCEDURE. IT WAS REPORTED ON THE SAME DAY (B)(6) 2026, A STROKE WAS OBSERVED DUE TO A VERY CALCIFIED ARCH. THE STROKE WAS NOT OBSERVED DURING THE PROCEDURE. MEDICATION WAS PROVIDED TO THE PATIENT AND NO FURTHER ISSUES WERE REPORTED.

  Patient problems: Stroke/CVA

  MAUDE report 24247463 ↗
• InjuryDec 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE THROUGH THE PIVOTAL STUDY FOR THE GORE® ASCENDING STENT GRAFT IN THE TREATMENT OF LESIONS OF THE ASCENDING AORTA (ASG DEVICE): ON (B)(6) 2025, THE PATIENT WAS IMPLANTED WITH GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM AND GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS (TBE AORTIC COMPONENT AND SIDE BRANCH) TO TREAT A THORACIC ANEURYSM. ON (B)(6) 2025, IT WAS REPORTED, THE PATIENT HAD A SMALL STROKE. ANTI-PLATELET THERAPY WAS PERFORMED. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Ischemia Stroke

  MAUDE report 23854219 ↗
• InjuryNov 4, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE THROUGH THE PIVOTAL STUDY FOR THE GORE® ASCENDING STENT GRAFT IN THE TREATMENT OF LESIONS OF THE ASCENDING AORTA (ASG DEVICE): ON (B)(6) 2024, THE PATIENT WAS IMPLANTED WITH GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS (TBE) AND GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL. ON (B)(6) 2024, DURING A 6-MONTH FOLLOW-UP CT IMAGING, A GREATER THAN 5MM ANEURYSM ENLARGEMENT WAS OBSERVED FROM BOTH THE SITE (BASELINE: 54.8MM, 6 MONTH IMAGING: 82MM) AND THE CORE LAB (BASELINE 70MM, 6 MONTH IMAGING: 81MM). AS PER MEDRIO DATABASE, THE AREA OF ANEURYSM ENLARGEMENT IS UNKNOWN.

  Patient problems: Aneurysm expansion

  MAUDE report 23469430 ↗
• InjuryJul 25, 2025Device Endoleak; Device Endoleak

  THE FIELD SALES ASSOCIATE (FSA) REPORTED THE FOLLOWING TO GORE: ON (B)(6) 2022, THE PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE TO TREAT AN ANEURYSM UTILIZING THE GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM (CTAG). THE PHYSICIAN SEALED THE ANEURYSM CONSERVATIVELY, WITH NO ENDOLEAK NOTED. THE PATIENT TOLERATED THE PROCEDURE. ON AN UNKNOWN DATE, A TYPE 1A ENDOLEAK WAS IDENTIFIED. ON (B)(6) 2023, A REINTERVENTION WAS PERFORMED TO ADDRESS THE TYPE 1A ENDOLEAK IN ZONE 3, WITH PROXIMAL EXTENSION USING ANOTHER CTAG. THE PATIENT TOLERATED THE PROCEDURE. ON AN UNKNOWN DATE, PROXIMAL THORACIC AORTIC DEGENERATION WAS OBSERVED. ON (B)(6) 2024, A SECOND REINTERVENTION OCCURRED. ANOTHER CTAG WAS DEPLOYED PROXIMALLY, AND A CTAG WAS USED TO BRIDGE INTO THE PREVIOUS CTAG FROM 2023 IMPLANTED. ON (B)(6) 2025, THE PATIENT WAS NOTED TO HAVE A TYPE 1A ENDOLEAK AND POSSIBLE TYPE 1B ENDOLEAK. ON (B)(6) 2025, AN EMERGENT ENDOVASCULAR INTERVENTION WAS PERFORMED. ANOTHER CTAG WAS DEPLOYED PROXIMALLY WITH INTENTIONAL COVERAGE OF THE LEFT SUBCLAVIAN ARTERY (LSA). DUE TO ACCESS LIMITATIONS, A DISTAL CTAG COULD NOT BE PLACED PROXIMAL TO THE CELIAC ARTERY, AND A 24 FR DRYSEAL COULD NOT

  Patient problems: Clinical Endoleak

  MAUDE report 22609204 ↗
• InjuryJul 15, 2025Device Endoleak; Device Endoleak

  THE FIELD SALES ASSOCIATE (FSA) REPORTED THE FOLLOWING TO GORE: ON (B)(6) 2021, THE PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE UTILIZING THE GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2025, THE PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE UTILIZING THE GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM (CTAG). IT WAS REPORTED THAT THE PATIENT PRESENTED WITH A TYPE 3 ENDOLEAK. THE PHYSICIAN PERFORMED A REINTERVENTION AND USED A CTAG TO RESOLVE THE ENDOLEAK. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Clinical Endoleak

  MAUDE report 22508339 ↗
• InjuryJun 23, 2025Device Endoleak; Device Endoleak

  THE FIELD SALES ASSOCIATE (FSA) REPORTED THE FOLLOWING TO GORE: ON (B)(6) 2022, THE PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE TO TREAT AN ANEURYSM UTILIZING THE GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM (CTAG). THE PHYSICIAN SEALED THE ANEURYSM CONSERVATIVELY, WITH NO ENDOLEAK NOTED. THE PATIENT TOLERATED THE PROCEDURE. ON AN UNKNOWN DATE, A TYPE 1A ENDOLEAK WAS IDENTIFIED. ON (B)(6) 2023, REINTERVENTION WAS PERFORMED TO ADDRESS THE TYPE 1A ENDOLEAK IN ZONE 3, WITH PROXIMAL EXTENSION USING ANOTHER CTAG. THE PATIENT TOLERATED THE PROCEDURE. ON AN UNKNOWN DATE, PROXIMAL THORACIC AORTIC DEGENERATION WAS OBSERVED. ON (B)(6) 2024, A SECOND REINTERVENTION OCCURRED. ANOTHER CTAG WAS DEPLOYED PROXIMALLY, AND A CTAG WAS USED TO BRIDGE INTO THE PREVIOUS CTAG FROM 2023 IMPLANTED. ON (B)(6) 2025, THE PATIENT WAS NOTED TO HAVE A TYPE 1A ENDOLEAK AND POSSIBLE TYPE 1B ENDOLEAK. ON (B)(6) 2025, AN EMERGENT ENDOVASCULAR INTERVENTION WAS PERFORMED. ANOTHER CTAG WAS DEPLOYED PROXIMALLY WITH INTENTIONAL COVERAGE OF THE LEFT SUBCLAVIAN ARTERY (LSA). DUE TO ACCESS LIMITATIONS, A DISTAL CTAG COULD NOT BE PLACED PROXIMAL TO THE CELIAC ARTERY, AND A 24 FR DRYSEAL COULD NOT BE

  Patient problems: Clinical Endoleak

  MAUDE report 22311900 ↗
• InjuryMay 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE THROUGH THE PIVOTAL STUDY FOR THE GORE® ASCENDING STENT GRAFT IN THE TREATMENT OF LESIONS OF THE ASCENDING AORTA (ASG DEVICE): ON (B)(6) 2024, THE PATIENT WAS IMPLANTED WITH GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS (TBE AORTIC COMPONENT AND SIDE BRANCH) AND A GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM FOR A THORACIC DISSECTION. ON (B)(6) 2024, IT WAS REPORTED THAT IMAGES REVEALED A TYPE IIIA ENDOLEAK (A/E#3). REPORTEDLY ON (B)(6) 2025, A REINTERVENTION OCCURRED TO TREAT TYPE III ENDOLEAK, BETWEEN THE TGMR373715/(B)(6) AND TAC123715C/(B)(6) DEVICES. THE PHYSICIAN SEALED WITH BALLOONING AND THE TYPE III ENDOLEAK WAS RESOLVED. THE PATIENT TOLERATED THE PROCEDURE. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Clinical Endoleak

  MAUDE report 22014626 ↗
• InjuryFeb 3, 2025Mechanical Problem; Mechanical Problem

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2025, A PATIENT WAS BEING TREATED USING GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL (CTAG). AFTER THE DEVICE WAS FULLY DEPLOYED, THE PHYSICIAN ATTEMPTED TO REMOVED THE GREY ANGULATION HANDLE, BUT WAS UNABLE TO DO SO. TWO STRINGS WERE STILL ATTACHED, AND WHEN TRYING TO PULL THE HANDLE THE DEVICE BEGAN ANGULATING ON THE INNER CURVE. THE PHYSICIAN THEN OPENED THE HATCH. LINES 3 AND 4 WERE STILL AVAILABLE IN THE HATCH. THE PHYSICIAN ATTEMPTED TO PULL LINE 4, BUT THE DEVICE CONTINUED TO ANGULATE. WHEN THE PHYSICIAN TRIED TO REMOVE LINE 3, THERE WAS RESISTANCE, AND THE PHYSICIAN WAS UNABLE TO REMOVE LINE 3. THE PHYSICIAN THEN BALLOONED THE STENT GRAFT. THIS RELEASED THE DEVICE FROM THE STENT GRAFT, AND THE PHYSICIAN WAS ABLE TO REMOVE THE DEVICE. HOWEVER, THE NOSE CONE REMAINED IN THE BODY. THE PHYSICIAN THEN CONVERTED TO OPEN SURGERY TO REMOVE THE OLIVE TIP. THE PATIENT THEN DIED DUE TO A RUPTURED ILIAC ARTERY. REPORTEDLY, THE RUPTURED ILIAC ARTERY WAS UNRELATED TO THE IMPLANTED DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21289713 ↗
• InjuryDec 16, 2024Device Endoleak; Device Endoleak

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2022, A PATIENT WAS TREATED FOR AN INTRAMURAL HEMATOMA IN THE DESCENDING THORACIC AORTA THAT HAD PROGRESSED TO ANEURYSMAL DEGENERATION USING TWO GORE® TAG® CONFORMABLE THORACIC STENT GRAFTS WITH ACTIVE CONTROL (CTAG). LATER, THE PATIENT WAS ENROLLED IN THE ARISE II CLINICAL TRIAL. ON (B)(6) 2024, WHILE REVIEWING CT SCANS FOR THE PATIENT, A PRODUCT SPECIALIST NOTICED THAT THERE WAS TYPE IIIA ENDOLEAK BETWEEN 2 PREVIOUSLY IMPLANTED CTAG DEVICES. ON (B)(6), 2024, WHILE PERFORMING THE ARISE PROCEDURE, A STENT GRAFT WAS PLACED RELINING THE JUNCTION. PER THE IMAGING EVALUATION, THE OVERLAP BETWEEN DEVICES WAS 2.2CM, LESS THAN THE IFU GUIDELINES OF 3.0CM.

  Patient problems: Obstruction/Occlusion

  MAUDE report 20938898 ↗
• MalfunctionOct 21, 2024Break; Break

  THE FSA REPORTED THE FOLLOWING TO GORE: ON (B)(6) 2024, THE PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE TO TREAT A DISSECTION UTILIZING THE GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM (CTAG) IN ZONE 1. IT WAS REPORTED THAT FOR AN ELECTIVE TREATMENT PLANT OF A TYPE B AORTIC DISSECTION, A 22FR DRYSEAL WAS PLACED ON A STANDARD MANNER OVER A LUNDERQUIST DOUBLE CURVE WIRE, FOLLOWED BY INTRODUCTION OF THE CTAG. THE PHYSICIAN ATTEMPTED TO DEPLOY THE FIRST STAGE AND THE HANDLE DETACHED FROM THE DEPLOYMENT LINE. THE STENT DID NOT DEPLOY AND IT WAS REMOVED WITHOUT ADDITIONAL MEASURES NECESSARY. THE PATIENT WAS NOT HARMED. AN ALTERNATE DEVICE WAS USED AND THE CASE WAS COMPLETED AS PREVIOUSLY PLANNED. THE PHYSICIAN DOES NOT KNOW CAUSED THE REPORTED EVENT TO OCCUR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20495245 ↗
• InjurySep 17, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2024, THE PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE TO TREAT A DISSECTION IN ZONE 3 LEFT SUBCLAVIAN ARTERY UTILIZING A GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM. ON (B)(6) 2024, THE PATIENT UNDERWENT A REINTERVENTION FOR PROXIMAL TYPE 1A ENDOLEAK WITH TWO ADDITIONAL GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM. REPORTEDLY, PATIENT CAME IN TO EMERGENCY ROOM IN MIDDLE OF THE NIGHT AND PHYSICIAN TREATED THE ENDOLEAK WITH BOTH PROXIMAL AND DISTAL EXTENSIONS USING GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM. PHYSICIAN HAS NO CAUSE FOR ENDOLEAK AND ANEURYSM GROWTH IS NOT AVAILABLE. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Clinical Endoleak

  MAUDE report 20235623 ↗
• InjuryAug 8, 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 A THORACIC AORTIC ANEURYSM USING TWO GORE® TAG® CONFORMABLE THORACIC STENT GRAFTS WITH ACTIVE CONTROL SYSTEM. IT WAS REPORTED THAT THERE WERE NO ISSUES DURING DEVICE PLACEMENT, AND THE PROXIMAL TGMR373715 WAS IMPLANTED JUST DISTAL TO THE PATIENT'S LEFT SUBCLAVIAN ARTERY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO REPORTED ISSUES AND THE PATIENT WAS DOING WELL POST OPERATIVELY. ON (B)(6) 2024, IT WAS REPORTED THAT THE PATIENT HAD DEVELOPED ACUTE LEFT LEG WEAKNESS. A SPINAL DRAIN WAS PLACED AND THE PATIENT WAS ADMITTED TO THE ICU FOR MONITORING. THE SUSPECTED CAUSE OF THE LEFT LEG WEAKNESS REPORTEDLY REMAINS UNKNOWN. NO PATIENT ANATOMY WAS SUSPECTED TO HAVE CAUSED OR CONTRIBUTED TO THE EVENT. THE PATIENT CONTINUES TO BE MONITORED.

  Patient problems: Paresis

  MAUDE report 19944476 ↗
• InjuryMay 9, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE THROUGH THE PIVOTAL STUDY FOR THE GORE® ASCENDING STENT GRAFT IN THE TREATMENT OF LESIONS OF THE ASCENDING AORTA (ASG DEVICE): ON (B)(6) 2024, THE PATIENT WAS IMPLANTED WITH GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS (TBE) AND GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM (CTAGAC) TO TREAT AN ASCENDING AORTIC ANEURYSM. ON (B)(6) 2024, IT WAS REPORTED THAT A TYPE 3 ENDOLEAK, DESCENDING THORACIC AORTIC DISSECTION, AND LEFT PRECENTRAL GYRUS CORTICAL INFARCT (STROKE) WAS OBSERVED. NO TREATMENT HAS BEEN PERFORMED. TYPE 3 ENDOLEAK REMAINS ONGOING, WITH NO TREATMENT PROVIDED. LEFT PRECENTRAL GYRUS CORTICAL INFARCT HAS RESOLVED WITHOUT SEQUELAE. ON (B)(6) 2024, A REINTERVENTION SURGERY WAS PERFORMED TO TREAT THE DISSECTION, IN WHICH ADDITIONAL CTAG DEVICES WERE IMPLANTED.

  Patient problems: Perforation of Vessels; Vascular Dissection

  MAUDE report 19277720 ↗
• InjuryMay 9, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE THROUGH THE PIVOTAL STUDY FOR THE GORE® ASCENDING STENT GRAFT IN THE TREATMENT OF LESIONS OF THE ASCENDING AORTA (ASG DEVICE): ON (B)(6) 2024, THE PATIENT WAS IMPLANTED WITH GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS (TBE) AND GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM (CTAGAC) TO TREAT AN ASCENDING AORTIC ANEURYSM. ON (B)(6) 2024, IT WAS REPORTED THAT A TYPE 3 ENDOLEAK, DESCENDING THORACIC AORTIC DISSECTION, AND LEFT PRECENTRAL GYRUS CORTICAL INFARCT (STROKE) WAS OBSERVED. NO TREATMENT HAS BEEN PERFORMED. TYPE 3 ENDOLEAK REMAINS ONGOING, WITH NO TREATMENT PROVIDED. LEFT PRECENTRAL GYRUS CORTICAL INFARCT HAS RESOLVED WITHOUT SEQUELAE. ON (B)(6) 2024, A REINTERVENTION SURGERY WAS PERFORMED TO TREAT THE DISSECTION, IN WHICH ADDITIONAL CTAG DEVICES WERE IMPLANTED.

  Patient problems: Stroke/CVA

  MAUDE report 19277531 ↗
• InjuryApr 26, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  THE FSA REPORTED THE FOLLOWING TO GORE: ON (B)(6) 2024, THE PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE IN ZONE 2- LCC TO TREAT AN SYMPTOMATIC INTRAMURAL HEMATOMA AND ANEURYSM UTILIZING GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM ENDOPROSTHESES. IT WAS REPORTED THAT THE PROCEDURE WAS COMPLETED AND EVERYTHING LOOKED GOOD. AFTER COMPLETION, THE FSA LEFT AND WAS CALLED BACK BY THE NURSE BECAUSE THE PHYSICIAN STATED THAT ANOTHER PIECE NEEDED TO BE PLACED. ONCE THE FSA REENTERED THE ROOM, THE PHYSICIAN STATED THAT THE PATIENTS PRESSURE WAS DROPPING AND THAT THE 2ND GRAFT PLACED (TGMR373715) HAD TORN. THE PHYSICIAN MENTIONED THAT THEY TOOK A PICTURE AND THERE WAS BLUSH. THE PHYSICIAN ALREADY HAD A NEW DEVICE AND WAS TO COVER WHAT THEY THOUGHT WAS TORN. HOWEVER, WHEN THEY PUT THE NEW DEVICE IN, UPON DEPLOYMENT, IT APPEARED THAT THEY WERE IN BETWEEN THE TWO OLD GRAFTS BECAUSE THE 3RD GRAFT DID NOT OPEN COMPLETELY. DUE TO THE GRAFT NOT OPENING COMPLETELY, THEY DECIDED TO BALLOON IT AND IT CRUSHED THE SECOND GRAFT WHICH SHOWED THE FSA THAT THEY WERE IN BETWEEN THE 2 GRAFTS ORIGINALLY PLACED. THEREFORE, IT COULD BE THAT WHEN THEY TOOK THEIR SHOT, THEY WERE NOT INSID

  Patient problems: Clinical Endoleak

  MAUDE report 19197934 ↗
• InjuryDec 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2023, THE PATIENT WAS TREATED FOR A THORACIC AORTIC DISSECTION. THE PHYSICIAN IMPLANTED TWO GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEMS. THE PATIENT TOLERATED THE PROCEDURE. ON 16-NOV-2023. THE FSA WAS INFORMED THAT THE PATIENT WAS EXPERIENCING BLEEDING, EITHER FROM A TYPE IA ENDOLEAK OR A DISSECTION OF A INTRAMURAL HEMATOMA. A GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS SIDE BRANCH DEVICE WAS IMPLANTED. THE BLEEDING WAS REPAIRED, AND THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Perforation of Vessels

  MAUDE report 18310539 ↗
• InjuryOct 3, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2023, PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE WITH AN INITIAL IMPLANT OF GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM (SN#: (B)(6) IN ZONE 2 LEFT COMMON CAROTID (LCC) TO TREAT A TYPE B DISSECTION W/ MALPERFUSION. THE CTAGAC WAS UP TO THE LEVEL OF THE LEFT COMMON CAROTID ARTERY WITH A CHIMNEY (GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS -11MMX 39MM) STENT IN THE LEFT SUBCLAVIAN ARTERY (LSA) THAT RESOLVED THE FENESTRATION AND THE TYPE B DISSECTION. THE FALSE LUMEN WAS NOT PRESSURIZED. PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2023, THE PATIENT UNDERWENT A REINTERVENTION PROCEDURE DUE TO A TYPE 1A ENDOLEAK INTO THE FENESTRATION NOW BETWEEN THE LEFT SUBCLAVIAN ARTERY (VBX CHIMNEY STENT) AND THE PREVIOUS GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM (SN#: (B)(6) IN THE DESCENDING AORTA THAT WAS LEAKING FROM AROUND THE GRAFT AND THE LEFT SUBCLAVIAN ARTERY AS IT APPEARED THE VBX PULLED OUT OF THE LSA. THEY PUT IN THREE GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX) FIRST THEN A GORE® EXCLUDER® AAA ENDOPROSTHESIS (SN#: (B)(6), PLL- ILIAC EXTENDER) TO EXTEND DISTALLY, W

  Patient problems: Clinical Endoleak

  MAUDE report 17863288 ↗
• InjuryAug 18, 2023Difficult or Delayed Positioning; Difficult or Delayed Positioning

  ON (B)(6) 2023, THIS PATIENT UNDERWENT OPEN SURGICAL/ENDOVASCULAR TREATMENT. THE PHYSICIAN REPORTED THAT A GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM WAS INTRODUCED AND ADVANCED WITHIN A FROZEN ELEPHANT TRUNK (FET) ON A TERUMO GLIDE WIRE FROM THE AORTIC ARCH ANTEGRADE INTO THE AORTA INTO AND DESCENDING AORTA. STAGE ONE AND TWO OF DEPLOYMENT WERE COMPLETED BUT STAGE 2 (DEPLOYMENT TO FULL DIAMETER) COULD NOT BE COMPLETED AS THE RED SLIDER ON THE ANGULATION FIBER HANDLE WOULD NOT RETRACT FULLY FROM THE DEVICE. IT WAS REPORTED THAT THEY PHYSICIAN PULLED AND PULLED ON IT WITH ENOUGH FORCE THAT FINALLY THEY BROKE THE RED PLASTIC SLIDER. DEPLOYMENT WAS THEN SUCCESSFULLY COMPLETED USING THE BACK UP DEPLOYMENT MECHANISM. THE PATIENT TOLERATED THE PROCEDURE.

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

  MAUDE report 17574904 ↗
• MalfunctionAug 8, 2023Difficult or Delayed Separation; Difficult or Delayed Separation

  ON (B)(6) 2023, THE PATIENT WAS TREATED FOR AN ENDOLEAK ORIGINATING FROM A PREVIOUSLY-IMPLANTED COOK DEVICE. A FROZEN ELEPHANT TRUNK PROCEDURE WAS PERFORMED. THE PHYSICIAN IMPLANTED A GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM, BUT EXPERIENCED DIFFICULTY IN DEPLOYING THE DEVICE. THE DELIVERY SYSTEM WOULDN¿T DEPLOY, DESPITE OPENING THE HATCH AND CUTTING LINES. THEY WERE ABLE TO CUT THE LINE FROM THE EXPOSED CHEST AND FINALLY REMOVE THE DELIVERY SYSTEM. THE PATIENT TOLERATED THE PROCEDURE. THE DELIVERY SYSTEM WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17480153 ↗
• MalfunctionApr 20, 2023Activation Failure; Activation Failure

  ON (B)(6) 2023, THE PATIENT UNDERWENT EMERGENT OPEN TREATMENT OF A TYPE A AORTIC DISSECTION USING ANTEGRADE RELEASE OF A GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM (CTAG A/C). VIA A MEDIAN STERNOTOMY (FROZEN ELEPHANT TRUNK TECHNIQUE). DUE TO THE OPEN NATURE OF THE PROCEDURE, A GUIDEWIRE AND SHEATH WERE NOT USED DURING CTAG A/C PLACEMENT. IT WAS REPORTED THAT THE CTAG A/C DEVICE DEPLOYED TO 50% WITH NO REPORTED ISSUES, BUT WOULD NOT DEPLOY FURTHER. THE BACK-UP HATCH WAS UTILIZED, BUT DEPLOYMENT WAS NOT POSSIBLE. THE DEVICE AND DELIVERY CATHETER WERE REMOVED MANUALLY DUE TO THE OPEN NATURE OF THE PROCEDURE. A NEW DEVICE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THE INITIAL CTAG A/C DEVICE WAS DISCARDED AT THE FACILITY. THERE WERE NO FURTHER REPORTED ISSUES. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16777251 ↗
• InjuryJan 13, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2022, THE PATIENT PRESENTED WITH A SYSTEMIC TYPE 3 DISSECTION AND UNDERWENT ENDOVASCULAR PROCEDURE IN THE DESCENDING AORTA UTILIZING TWO GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM (TGMR373715 AND TGMR373710). THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2022, THE PATIENT UNDERWENT A PLANNED REINTERVENTION FOR AN ENDOVASCULAR ZONE 4 DESCENDING THORACIC AORTA TO TREAT A PROXIMAL RETROGRADE TYPE B DISSECTION UTILIZING A GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM AND GORE® DRYSEAL FLEX INTRODUCER SHEATH. REPORTEDLY, PATIENT CAME IN SYMPTOMATIC THROUGH THE ER WITH TYPE 1A LEAK WITH RETROGRADE B DISSECTION AND REINTERVENTION WAS DONE AS THERE WAS A FENESTRATION THAT WAS NOT COVERED ON THE INITIAL PROCEDURE, AND IT WAS REPAIRED DURING THE REINTERVENTION. REPORTEDLY, THE TGMR373715 WAS MOST PROXIMAL DEVICE AND IMMEDIATELY ADJACENT TO THE RETROGRADE TYPE B DISSECTION AND THE DEVICE WAS PLACED IN AN UNDISSECTED AREA IN THE DESCENDING AORTA. THE REINTERVENTION WAS THE CAUSE OF THE NEW DISSECTION DUE TO DISEASE PROGRESSION. THE REINTERVENTION WAS SUCCESSFUL, AND THE PATIENT TOLERATED THE PRO

  Patient problems: Clinical Endoleak; Vascular Dissection

  MAUDE report 16156891 ↗
• MalfunctionAug 8, 2022Fracture; Fracture

  ON (B)(6), THE PATIENT UNDERWENT OPEN TREATMENT OF A RUPTURED THORACIC AORTIC DISSECTION USING A GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM. IT WAS REPORTED THAT, AS THE PHYSICIAN ROTATED THE RED LOCKWIRE HANDLE TO INITIATE REMOVAL OF THE LOCKWIRE, THE LOCKWIRE BROKE AWAY FROM THE HANDLE. THERE WAS NO RESISTANCE REPORTED PRIOR TO THE LOCKWIRE BREAK. THERE WAS NO REPORTED SUSPECTED CAUSE FOR THE LOCKWIRE BREAK. IT WAS NOTED THAT THE DEVICE WAS DEPLOYED OVER A GUIDEWIRE. IT WAS REPORTED THAT THE PHYSICIAN OPENED THE HANDLE (NOT THE BACKUP DEPLOYMENT HATCH) AND MANUALLY GRABBED THE LOCKWIRE TO COMPLETE DEPLOYMENT. DEPLOYMENT WAS SUCCESSFULLY COMPLETED. THERE WERE NO FURTHER REPORTED ISSUES. THERE WERE NO PATIENT ADVERSE EVENTS. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15188663 ↗
• InjuryJun 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2021, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR A THORACIC AORTIC ANEURYSM AND WAS IMPLANTED WITH TWO GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM ENDOPROSTHESES. A TGMR373720 WAS THE MOST PROXIMAL DEVICE, HAVING BEEN PLACED AT THE LEFT COMMON CAROTID ARTERY WITH A SNORKEL WITHIN THE LEFT SUBCLAVIAN ARTERY. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2022, THE PATIENT UNDERWENT REINTERVENTION FOR A PROXIMAL TYPE I ENDOLEAK (DATE OF ONSET UNKNOWN) AND AN ADDITIONAL GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM (TGMR373715) WAS PLACED PROXIMALLY. THE PHYSICIAN REPORTED THAT THE DEVICE WAS DEPLOYED AGGRESSIVELY ON TARGET AND NEEDED TO BE RETRACTED DUE TO PARTIAL COVERAGE OF THE INNOMINATE ARTERY. THE DEVICE WAS RETRACTED SUCCESSFULLY WITH LOCK WIRE IN PLACE, BUT IT IS SUSPECTED THAT IT MIGRATED PROXIMALLY WHEN THE LOCK WIRE WAS REMOVED DUE TO STORED ENERGY AND MANEUVERING THROUGH THE PREVIOUSLY PLACED TGMR DEVICE. THE DEVICE WAS SUCCESSFULLY RETRACTED TO A SATISFACTORY POSITION WITH A GORE TRI-LOBE BALLOON. NO INJURY WAS NOTED TO THE PATIENT AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. AT THE CONCLUSION OF THE PR

  Patient problems: Aneurysm

  MAUDE report 14755042 ↗

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-1236-06 · Apr 28, 2006 · Terminated
  GORE TAG THORACIC ENDOPROSTHESIS System, Endovascular Graft, Aortic Aneurysm Treatment, Catalogue Number TG3410, 34mm x 10cm
• Z-1237-06 · Apr 28, 2006 · Terminated
  GORE TAG THORACIC ENDOPROSTHESIS System, Endovascular Graft, Aortic Aneurysm Treatment, Catalogue Number TG3415, 34mm x 15cm