GORE TAG Thoracic Branch Endoprosthesis TAC124515ARecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00733132654253), received between Jul 27, 2023 and Jul 29, 2026 — classified as 1 death, 5 injuries.

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

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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryJul 29, 2026Device Endoleak

  The following was reported to Gore: On (b)(6), 2026, the patient underwent an endovascular reintervention to treat a Type IA endoleak associated with a previously implanted GORE® TAG® Thoracic Branch Endoprosthesis (TBE). To address the endoleak, the physician elected to reline the previously implanted zone 2 TBE with a zone 0 TBE. As part of the repair, the side branch needed to be extended beyond the distal end of the newly implanted zone 0 TBE component. A GORE® VIABAHN® Endoprosthesis with HEPARIN Bioactive Surface (VIABAHN Device) and a GORE® VIABAHN® FORTEGRA Venous Stent (FORTEGRA Device) were deployed through the portal of the previously implanted zone 2 TBE and extended below the trailing end of the zone 0 TBE. The physician elected to use the VIABAHN Device and the FORTEGRA Device to reinforce the TBE side branch and aid in radial force.During the procedure, the VIABAHN Device was implanted fist then the FORTEGRA Device. When withdrawing the FORTEGRA delivery catheter, the catheter tip appeared to have gotten stuck on the VIABAHN Device and pulled on both the VIABAHN Device and FORTEGRA Device back, creating a gap. The physician was unable to remove the FORTEGRA delivery

  Patient problems: Clinical Endoleak

  MAUDE report 50075152 ↗
• DeathJun 1, 2026Appropriate Device Problem Term/Code Not Available

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2026, THE PATIENT UNDERWENT A THORACIC ENDOVASCULAR AORTIC REPAIR TO TREAT AN ANEURYSM, UTILIZING GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS (TBE AORTIC COMPONENT). IT WAS REPORTED DURING ADVANCEMENT OF THE TBE DEVICE THROUGH THE 24 FR SHEATH, IT WAS NOTED THAT THE SYSTEM¿S THROUGH-WIRE HAD INADVERTENTLY PASSED BEHIND A PREVIOUSLY IMPLANTED PALMAZ STENT. THE TBE AND THE 24 FR SHEATH WERE REMOVED AS ONE UNIT. IT WAS ALSO REPORTED THE ANGULATION THROUGHOUT THE DESCENDING AORTA AND ARCH WAS QUITE EXTENSIVE. A GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL (CTAGAC) STENT GRAFT WAS SUBSEQUENTLY DEPLOYED TO SECURE AND ENTRAP THE EXISTING PALMAZ STENT, FOLLOWED BY BALLOONING OF THE CTAGAC DEVICE TO OPTIMIZE WALL APPOSITION. ALLEGEDLY WHILE ATTEMPTING TO REINTRODUCE A LUNDERQUIST WIRE, THE PATIENT'S BLOOD PRESSURE DROPPED. CARDIOPULMONARY RESUSCITATION WAS INITIATED IMMEDIATELY. AN INTRA-AORTIC BALLOON PUMP WAS INSERTED VIA THE EXISTING 24 × 65 DRYSEAL SHEATH. TRANSESOPHAGEAL ECHOCARDIOGRAPHY DEMONSTRATED NO PERICARDIAL EFFUSION. CORONARY ANGIOGRAPHY REVEALED EXTENSIVE THROMBUS WITHIN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. M

  Patient problems: Low Blood Pressure/ Hypotension; Thrombosis/Thrombus

  MAUDE report 25352591 ↗
• InjuryMay 26, 2026Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2025, THE PATIENT UNDERWENT A REINTERVENTION FOR TREATMENT OF A PENETRATING AORTIC ULCER (PAU) FOLLOWING PRIOR TEVAR, WITH A ZONE 0 (BRACHIOCEPHALIC ARTERY [BCA]/ASCENDING AORTA) REPAIR UTILIZING A GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS. AT THE SIX-MONTH FOLLOW-UP, COMPUTED TOMOGRAPHY (CT) IMAGING DEMONSTRATED NO ABNORMALITIES. ON (B)(6) 2026, A ONE-YEAR FOLLOW-UP CT SCAN IDENTIFIED A RETROGRADE TYPE A AORTIC DISSECTION ORIGINATING AT THE SINOTUBULAR JUNCTION (STJ). THE FINDING WAS SUBSEQUENTLY REPORTED TO GORE ON (B)(6) 2026. THE EXACT ONSET DATE OF THE DISSECTION IS UNKNOWN. THE REPORTER INDICATED THAT THE EVENT OCCURRED AT AN INDETERMINATE TIME BETWEEN THE SIX-MONTH AND ONE-YEAR FOLLOW-UP INTERVALS. AT THE TIME OF REPORTING, THE PATIENT WAS DESCRIBED AS CLINICALLY STABLE. NO DEFINITIVE CAUSE FOR THE DISSECTION HAS BEEN ESTABLISHED. THE TREATING PHYSICIAN IS CURRENTLY EVALUATING TREATMENT OPTIONS. POTENTIAL MANAGEMENT MAY INCLUDE OPEN SURGICAL REPAIR; HOWEVER, NO INTERVENTION HAD BEEN SCHEDULED AT THE TIME OF REPORTING.

  Patient problems: Vascular Dissection

  MAUDE report 25285828 ↗
• InjuryFeb 6, 2026Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING DETAILS WERE REPORTED TO GORE: ON (B)(6) 2025, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF A ZONE 0 (ASCENDING AORTA) WITH BCA (BRACHIOCEPHALIC ARTERY) TEVAR TREATMENT FOR ANEURYSM FROM A DISSECTION. THE PATIENT WAS IMPLANTED WITH GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS DEVICE AND GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM (TSB121706A, TGMR373115, TSB121706A, TAC124515A, TE4546A). THE PATIENT TOLERATED THE PROCEDURE WITH GOOD RESULTS. ON (B)(6) 2026, THE PATIENT UNDERWENT REINTERVENTION TO TREAT CONTINUED ANEURYSMAL DEGENERATION OF THE ANEURYSM DUE TO INFECTION OF THE PATIENT¿S AORTA AND OF THE ANEURYSM. THE SIDE BRANCH DEVICE WAS EXTENDED PROXIMALLY AND THE TBE AORTIC COMPONENT WAS EXTENDED WITH A CTAG. THE PATIENT TOLERATED THE PROCEDURE. THE CAUSE OF THE INFECTION IS NOT KNOWN. THE PHYSICIAN REPORTS THAT AT THE PATIENT¿S 30-DAY FOLLOW-UP COMPUTED TOMOGRAPHY (CT) ALL LOOKED GOOD HEALTHY AND NO DEVICE ISSUES OR CONCERNS NOTED. THE PATIENT HAD OBSERVED DEVICE ISSUES. THE PATIENT THEN STATED THEY HAD A FOLLOW-UP CT AT ANOTHER HOSPITAL IN JANUARY AND THE AORTA HAD GOTTEN PROGRESSIVELY WORSE. THE PHYSICIAN DOES NOT KNOW IF THERE WAS UND

  Patient problems: Post Operative Wound Infection

  MAUDE report 24283686 ↗
• InjuryJun 3, 2024Premature Activation; Premature Activation

  THE FSA REPORTED THE FOLLOWING TO GORE: ON (B)(6) 2024, THE PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE IN ZONE 0 - ASCENDING AORTA TO TREAT AN ANEURYSM UTILIZING THE GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS (AORTIC COMPONENT). IT WAS REPORTED THAT THE PROXIMAL END OF THE DEVICE WAS PREMATURELY DEPLOYED DUE TO THE PHYSICIAN ATTEMPTING TO RETRACT IT BACK INTO THE SHEATH TO REMOVE IT DUE TO EXCESSIVE WIRE WRAP. THE PHYSICIAN WAS ABLE TO REMOVE THE GRAFT AND FINISH THE CASE WITH A NEW TBE GRAFT. UPON REMOVAL OF THE SHEATH THERE WAS SLOW FLOW DOWN THE RIGHT EXTERNAL ILIAC ARTERY. HE USED AN IVUS TO CONFIRM A SMALL INTIMAL DISSECTION AND USED A 10X30 CORDIS SMART STENT TO RESOLVE IT. HE BELIEVES THE EXTERNAL ILIAC WAS DAMAGED BY THE SHEATH AS THERE WAS SOME INTIMAL TISSUE ON IT WHEN IT WAS REMOVED. THERE WAS NO RESISTANCE FELT WHEN ADVANCING THE SHEATH. THE PATIENT IS DOING FINE THIS MORNING WITH NO LEG PERFUSION ISSUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19447199 ↗
• InjuryJul 27, 2023Adverse 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), 2023, THE PATIENT WAS TREATED FOR A ZONE 2 TYPE B THORACIC DISSECTION WITH GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS (TBE). IT WAS REPORTED THAT DURING THE PROCEDURE, WHILE THE PHYSICIAN WAS ADVANCING THE GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS TAC124515A/(B)(6), THROUGH THE BLADDER OF THE GORE® DRYSEAL FLEX INTRODUCER SHEATH (DSF2465/(B)(6)) THE ¿NITINOL FISHTAILS OUTSIDE OF THE DEVICE PUNCTURED THE BLADDER OF THE SHEATH¿. THERE WAS APPROXIMATELY LESS THAN 100CC OF BLOOD LOSS, NO HEMODYNAMIC IMPAIRMENT, AND NO BLOOD TRANSFUSION WAS REQUIRED. THE SHEATH WAS REMOVED, AND A DIFFERENT DEVICE WAS USED FOR THE PROCEDURE. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Vascular Dissection

  MAUDE report 17410129 ↗

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