GORE TAG Conformable Thoracic Stent Graft TGM454515Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00733132646999), received between Jul 3, 2020 and Jul 31, 2026 — classified as 2 deaths, 6 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryJul 31, 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 the GORE® TAG® Thoracic Branch Endoprosthesis (TBE Aortic Component and Side Branch) to treat a thoracic aneurysm in the descending thoracic aorta. The patient tolerated the procedure. It was reported that follow up images dated (b)(6) 2026, revealed device compression. The event is ongoing.

  Patient problems: Aortic dissection

  MAUDE report 50105884 ↗
• InjurySep 3, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  THE FOLLOWING WAS REPORTED TO GORE: IN (B)(6) 2022, A GORE® TAG® CONFORMABLE THORACIC STENT GRAFT (CTAG) WAS IMPLANTED. ON (B)(6) 2024, A GORE ASSOCIATE WAS NOTIFIED ABOUT A PATIENT WHO HAD A TYPE IA ENDOLEAK IN THE ASCENDING AORTA. ON (B)(6) 2024, A REINTERVENTION WAS PERFORMED, EXTENDING WITH A CTAG DEVICE.

  Patient problems: Clinical Endoleak

  MAUDE report 20125912 ↗
• InjuryFeb 19, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2021, THE PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE UTILIZING A GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM. ON JANUARY 26, 2024, THE FIELD SALES ASSOCIATE WAS MADE AWARE THAT A REINTERVENTION WILL BE DONE ON (B)(6) 2024 DUE TO A TYPE B DISSECTION (DISEASE PROGRESSION) DISTAL TO THE ORIGINAL IMPLANT. ON (B)(6) 2024, PATIENT UNDERWENT AN ENDOVASCULAR REINTERVENTION IN ZONE 4 UTILIZING A GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM (CTAGAC) AND A 24FR GORE® DRYSEAL FLEX INTRODUCER SHEATH. THE CTAGAC DEVICE WAS OPENED AND INSERTED INSIDE THE PATIENT BUT NOT IMPLANTED AS IT WAS TIGHT IN THE SHEATH, WITH DIFFICULTY PHYSICIAN GOT IT THROUGH THE SHEATH THEN THE SHEATH BACKED OUT OF THE VESSEL AND PHYSICIAN TRIED TO PULL THE DEVICE THROUGH THE SHEATH TO TAKE IT OUT, SO HE COULD REINTRODUCE THE DILATOR BUT WERE UNABLE TO COMPLETELY ADVANCE THE DEVICE THROUGH THE SHEATH. DEVICE WAS REMOVED ALONG WITH THE SHEATH AND ON THE BACK TABLE, IT WAS VISIBLE THAT THE SHEATH WAS DAMAGED AT THE TIP FROM TRYING TO PULL THE STENT BACK INTO IT. PHYSICIAN THEN USED TWO GORE® TAG® CONFORMABLE THORACIC STENT G

  Patient problems: Vascular Dissection

  MAUDE report 18735773 ↗
• MalfunctionFeb 6, 2023Device Handling Problem; Device Handling Problem

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2023, THE PATIENT UNDERWENT A PRE-PLANNED OPEN PROCEDURE WITH A FROZEN ELEPHANT TRUNK (FET) PROCEDURE UTILIZING A GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM (TGM454515) OFF THE SHELF. REPORTEDLY, UPON THE DEPLOYMENT OF THE DEVICE, THE SECONDARY DEPLOYMENT LINE WHERE THE RED HANDLE/LINE COMES OFF THE THUMB LEVEL WAS EITHER STUCK OR BROKEN, WHEN THE PHYSICIAN TWISTED IT. THE DEPLOYMENT LINE BROKE AND THE PHYSICIAN WAS UNABLE TO USE THE GRAFT. THE PHYSICIAN WAS ABLE TO COMPLETE THE CASE WITH A SEPARATE LIKE DEVICE AND HAD NO ISSUES DEPLOYING. A GORE REPRESENTATIVE WAS NOT PRESENT FOR THIS CASE.

  Patient problems: Insufficient Information

  MAUDE report 16308773 ↗
• DeathSep 12, 2022No Apparent Adverse Event; No Apparent Adverse Event

  ON (B)(6) 2022, THIS PATIENT PRESENTED EMERGENTLY FOR TREATMENT OF A CONTAINED RUPTURE OF A ZONE 0 ASCENDING AORTIC THORACIC ANEURYSM. THE PHYSICIAN DECIDED THAT BEST COURSE OF ACTION WAS TO OPEN THE CHEST AND TIE A BIFURCATED GRAFT FROM THE ASCENDING AORTA INTO THE INNOMINATE AND LEFT CAROTID AND THEN PLACE AN ENDOGRAFT TO SEAL THE RUPTURE. AFTER THE PHYSICIAN HAD SEWED IN A BIFURCATED GRAFT TO THE HEAD VESSELS, HE WAS UNABLE TO CONTROL THE BLEEDING AND DECIDED TO IMPLANT A GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM (CTAG AC) IN AN ANTEGRADE FASHION UNDER DIRECT VISUALIZATION. THE AORTA WAS PUNCTURED WITH AN 18 GAUGE NEEDLE AND A 260CMX.035 GLIDE WIRE WAS ADVANCED, AND A 90CM BERNSTEIN CATHETER WAS INTRODUCED AND A WIRE EXCHANGE WAS PREFORMED EXCHANGING THE GLIDE WIRE FOR A LUNDERQUIST® 260CMX.035 STIFF WIRE. A GORE® DRYSEAL FLEX INTRODUCER SHEATH (DSF) WAS ADVANCED 1CM INTO THE AORTA AND THEN CTAG AC WAS ADVANCED THROUGH THE DSF AND DEPLOYED. THERE WAS STILL BLEEDING SO A SECOND CTAG AC WAS DEPLOYED AND THEN BALLOONED. THE PHYSICIAN WAS STILL UNABLE TO CONTROL THE BLEEDING AND THE DECISION WAS MADE TO END THEIR ATTEMPTS TO SAVE THE PATIENT. TIME OF DEA

  Patient problems: Ruptured Aneurysm

  MAUDE report 15407471 ↗
• InjuryJun 30, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON SEPTEMBER 30, 2019, THIS PATIENT PRESENTED WITH A THORACIC AORTIC ANEURYSM AND WAS TREATED USING GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM [TGM454515 (L/S#:(B)(4) AND TGM454520 L/S# (B)(4). ON (B)(6) 2022, THE PHYSICIAN PERFORMED AN ANGIOGRAM TO IDENTIFY A POSSIBLE ENDOLEAK AND PERFORMED A SUBSEQUENT DEBRANCHING OF THE THORACIC AORTIC ARCH TO IDENTIFY DISEASE PROGRESSION PROXIMAL TO THE ORIGINAL CTAG GRAFT PLACEMENT AND DETERMINE IF FURTHER TREATMENT WAS WARRANTED. AT THE TIME OF SURGERY, IT WAS DETERMINED BY THE PHYSICIAN THAT THE APPROPRIATE TREATMENT WAS TO EXTEND PROXIMAL SEAL USING AN ADDITIONAL CTAG DEVICE. A CTAG [TGM454515 L/S#: (B)(4)] WAS PLACED AS A PROXIMAL EXTENSION, AND THE LEAK WAS NOTED TO RESOLVE. THE PATIENT TOLERATED THE PROCEDURE WELL. PATIENT IS REPORTED TO BE DOING FINE.

  Patient problems: Aneurysm

  MAUDE report 14876477 ↗
• InjuryApr 25, 2022Material Perforation; Material Perforation

  ON (B)(6) 2021, THE PATIENT WAS TREATED FOR KOMMERELL DIVIRTICULUM/ ABERRANT SUBLCLAVIAN . THE PHYSICIAN IMPLANTED A GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2022, THE GORE FSA RECEIVED A SCAN FROM THE PHYSICIAN THAT APPEARS TO BE A POSSIBLE TYPE III ENDOLEAK. IMAGES WERE RECEIVED FOR EVALUATION. AS OF THIS TIME, THE PHYSICIAN HAS NOT TAKEN ANY ACTION TO ADDRESS THE ENDOLEAK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14194120 ↗
• MalfunctionJan 14, 2022Break; Break

  ON (B)(6) 2021, THE PATIENT WAS TREATED FOR AN ABDOMINAL AORTIC ANEURYSM. A GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM WAS IMPLANTED. WHILE ATTEMPTING TO DEPLOY A SECOND GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM. THE LOCK PIN WIRE TAB THAT ATTACHES TO THE HANDLE BROKE OFF WHEN THE PHYSICIAN PULLED BACK, THE PROXIMAL END OF THE STENT ALSO PULLED BACK AND ACCORDIANED IN ON ITSELF. THE TAB COMPLETELY BROKE OFF THE RED HANDLE. FORTUNATELY, THE FIRST STENT GRAFT IN COMBINATION WITH THE SECOND GRAFT WERE ABLE TO SUCCESSFULLY TREAT THE ANEURYSM, AND THE PATIENT TOLERATED THE PROCEDURE. THE DELIVERY DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13259085 ↗
• InjuryApr 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 AN ABERRANT RIGHT SUBCLAVIAN ANEURYSM USING A GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM. IT WAS REPORTED THAT PRIOR TO IMPLANT OF DEVICE THERE WERE CAROTID SUBCLAVIAN ARTERY BYPASSES BILATERALLY. THE GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM WAS DEPLOYED SUCCESSFULLY. THE PATIENT TOLERATED THE PROCEDURE. REPORTEDLY WITHIN 24 HOURS THE PATIENT HAD A STROKE. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Aneurysm

  MAUDE report 11616945 ↗
• DeathJul 3, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FIELD SALES ASSOCIATE REPORTED THE FOLLOWING: ON (B)(6) 2020, THIS PATIENT UNDERWENT TREATMENT FOR A CHRONIC STANFORD TYPE B DISSECTION WITH ANEURYSMAL DEGENERATION AND WAS IMPLANTED WITH FOUR GORE® TAG® CONFORMABLE THORACIC STENT GRAFTS WITH ACTIVE CONTROL SYSTEM. COILING AND PLUGGING OF THE FALSE LUMEN WAS PERFORMED AND A KNICKERBOCKER TECHNIQUE USING A GORE® TRI-LOBE BALLOON CATHETER WAS USED TO SUCCESSFULLY PLACE THE FIRST THREE DEVICES. THE PHYSICIAN THEN CHANGED OUT THE GORE® TRI-LOBE BALLOON CATHETER WITH A 46MM CODA® BALLOON CATHETER FOR PLACEMENT OF THE FOURTH DEVICE. AT THIS TIME A RUPTURE OF THE FALSE LUMEN WAS SUSPECTED, THE PATIENT UNDERWENT A BLOOD TRANSFUSION AND OTHER ADJUNCTIVE MEASURES WITHOUT SUCCESS. THE PATIENT EXPIRED INTRAPROCEDURAL. THERE WAS NO ALLEGATION OF DEFICIENCY OF ANY OF THE GORE DEVICES DURING THE PROCEDURE. THE CAUSE OF DEATH IS BELIEVED TO BE RUPTURE OF THE FALSE LUMEN.

  Patient problems: Vascular Dissection

  MAUDE report 10228202 ↗

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-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