GORE TAG Thoracic Branch Endoprosthesis TAC084515ARecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00733132654154), received between Dec 21, 2023 and Sep 10, 2025 — classified as 1 death, 4 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 reports).

1 other recall cover devices cleared under the same FDA submission (P210032); 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjurySep 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2025, PATIENT UNDERWENT A THORACIC ENDOVASCULAR AORTIC REPAIR (TEVAR) TO TREAT A DISSECTION UTILIZING A GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS (AORTIC COMPONENT, SIDE BRANCH AND AORTIC EXTENDER). PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2025, PATIENT UNDERWENT AN ENDOVASCULAR REINTERVENTION PROCEDURE ON A PRIOR TEVAR TO TREAT AN ENDOLEAK AND DISSECTION UTILIZING A GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM (CTAGAC). REPORTEDLY, THERE WAS A TYPE 1A ENDOLEAK FROM THE LEFT SUBCLAVIAN ARTERY WITH THE SIDE BRANCH AND A DISTAL EXTENSION OF THE TYPE B DISSECTION FROM THE AORTIC COMPONENT. THE ENDOLEAK IS POSSIBLY DUE TO A FENESTRATION THAT WAS NOT SEALED PERFECTLY ON THE PROXIMAL SIDE DURING THE ORIGINAL PROCEDURE AND THE DISTAL SIDE WHERE THE DISSECTION MIGHT NOT HAVE BEEN FULLY COVERED. PHYSICIAN IS UNSURE OF THE CAUSE, IF ITS A NEW FENESTRATION OR SIMPLY DID NOT COVER IT ENOUGH DURING THE INITIAL PROCEDURE AS THERE IS FALSE LUMEN PROXIMALLY (ANEURYSM SIZE UNKNOWN) AND TYPE B DISSECTION DISTALLY, WHICH PHYSICIAN FIXED BY ADDING 10-15 TERUMO COILS PROXIMALLY IN THE FALSE LUMEN, JUST OUTSIDE THE LEFT SUBCLAVIAN

  Patient problems: Aneurysm expansion; Vascular Dissection

  MAUDE report 23015364 ↗
• InjuryOct 9, 2024Fluid/Blood Leak; Fluid/Blood Leak

  ON (B)(6) 2024, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR A ZONE 2 THORACIC ANEURYSM AND WAS IMPLANTED WITH GORE® TAG® THORACIC BRANCH ENDOPROSTHESES (TBE). THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2024 THE PATIENT UNDERWENT REINTERVENTION FOR A SMALL LATE FILLING ENDOLEAK (TYPE/ORIGIN UNKNOWN) BUT BELIEVED TO BE NEAR THE PORTAL. THE PORTAL AND THE (TSB) WERE RE-BALLOONED AND THE PHYSICIAN CHOSE TO RELINE AND EXTEND THE AORTIC COMPONENT ALSO. A LATE SMALL FILLING ENDOLEAK WAS STILL OBSERVED AND THE PHYSICIAN CHOSE TO CONCLUDE THE PROCEDURE AS HE STILL WAS UNABLE TO DETERMINE (TYPE/ORIGIN). HE WILL MONITOR THE PATIENT AND FOLLOW-UP WITH ANOTHER CT. THE PATIENT TOLERATED THE PROCEDURE.

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

  MAUDE report 20413137 ↗
• InjuryOct 6, 2024Device Endoleak; Device Endoleak

  ON (B)(6) 2023, PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE TO TREAT A ZONE-2 ANEURYSM UTILIZING GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS. ON (B)(6) 2024, PHYSICIAN SENT OVER A CT SCAN TO THE FSA, WHICH SHOWED AN ENDOLEAK. THE CT SCAN WAS DATED (B)(6) 2024. ON (B)(6) 2024, DURING A FOLLOW-UP VISIT, A TYPE III ENDOLEAK NEAR THE PORTAL AND ANEURYSM ENLARGEMENT (UNKNOWN AMOUNT) WAS SEEN ON CT IMAGING. PHYSICIAN RECOMMENDS REINTERVENTION SURGERY TO TREAT THIS ENDOLEAK. ON (B)(6) 2024, A REINTERVENTION SURGERY WAS PERFORMED. PHYSICIAN BALLOONED THE PORTAL. AN ANGIOGRAM WAS PERFORMED, AND NO ENDOLEAK WAS OBSERVED. PATIENT TOLERATED THE PROCEDURE. THE CAUSE OF THE ENDOLEAK REMAINS UNKNOWN.

  Patient problems: Clinical Endoleak

  MAUDE report 20380366 ↗
• DeathJul 1, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2024, THE PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE TO TREAT CHRONIC TYPE B DISSECTION UTILIZING GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS (SIDE BRANCH AND BRANCH AORTIC COMPONENT) WITH LANDING PROXIMALLY AT A COMMON TAKEOFF OF INNOMINATE AND LEFT CAROTID ARTERY THEN EXTENDED DISTALLY WITH TWO GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM. THE CASE WENT AS PLANNED WITH NO DEPLOYMENT ISSUES. SOMETIME ON THE WEEKEND OF (B)(6) 2024 (EXACT DATE UNKNOWN), THE PATIENT WAS LEAVING THE HOSPITAL, WHEN THE PATIENT COLLAPSED, MEDICAL TEAM INTERVENED BUT PATIENT PASSED AWAY. UPON AUTOPSY, THE PHYSICIAN BELIEVES THE PROXIMAL BARE STENT PROTRUDED THROUGH THE AORTIC WALL. ON (B)(6) 2024, THE FIELD SALES ASSOCIATES WERE NOTIFIED OF PATIENT DEATH.

  Patient problems: Perforation

  MAUDE report 19642729 ↗
• InjuryDec 21, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2022, PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE TO TREAT AN ANEURYSM IN ZONE 3 LEFT SUBCLAVIAN ARTERY (LSA) UTILIZING GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS. ON NOVEMBER 28, 2023, THE FIELD SALES ASSOCIATE (FSA) WAS NOTIFIED BY THE PHYSICIAN THAT THE PATIENT PRESENTED WITHIN THE LAST 48 HOURS WITH A TYPE A DISSECTION. AS OF NOW, THEY ARE UNAWARE IF IT'S DEVICE RELATED. IT SEEMS TO BE AN AORTIC DEGENERATION AT THE PROXIMAL POINT OF THE AORTIC BRANCH COMPONENT GRAFT. PHYSICIAN BELIEVES ITS DISEASE PROGRESSION DUE TO PATIENT CONDITION AND THERE ARE NO ANATOMICAL ISSUES. THE PHYSICIAN PLANS TO RE-INTERVENE AND DO OPEN SURGERY TO REPAIR THE ASCENDING AORTA IN THE NEXT FEW DAYS BUT DATE HAS NOT BEEN DECIDED. PATIENT IS BEING MONITORED.

  Patient problems: Vascular Dissection

  MAUDE report 18375924 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P210032. One submission often covers many models, so check the product and lot details in each record.

• Z-2672-2026 · May 19, 2026 · Open, Classified
  GORE TAG Thoracic Branch Endoprosthesis Side Branch Component Catalog Numbers (by Region) United States (includes Puerto Rico) and Canada: TSB080806A, TSB081006A, TSB081206A, TSB08