GORE TAG Thoracic Branch Endoprosthesis TAC083715ARecalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00733132654116), received between Nov 28, 2022 and Jun 4, 2026 — classified as 2 deaths, 10 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Device Endoleak” (4 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• InjuryJun 4, 2026Device Endoleak

  THE FIELD SALES ASSOCIATE (FSA) REPORTED THE FOLLOWING TO GORE: ON (B)(6) 2026, THE PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE TO TREAT AN ANEURYSM UTILIZING THE GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS (TBE). ON (B)(6) 2026, THE PATIENT UNDERWENT A 2ND STAGED ENDOVASCULAR PROCEDURE UTILIZING THE GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE). ON (B)(6) 2026, THE PATIENT RETURNED FOR A REINTERVENTION BASED ON CT FINDINGS THAT SUGGESTED A TYPE IA ENDOLEAK AT THE PROXIMAL TBE GRAFT. THE INTERVAL CT SCAN BETWEEN THE TBE AND TAMBE PROCEDURES HAD SHOWN NO EVIDENCE OF ENDOLEAK; HOWEVER, THE POST TAMBE CT SCAN RAISED CONCERN FOR A PROXIMAL TYPE IA LEAK. DURING THE PROCEDURE, AN ARTERIOGRAM WAS PERFORMED TO IDENTIFY THE SOURCE OF THE SUSPECTED TYPE IA ENDOLEAK. NO TYPE IA ENDOLEAK WAS VISUALIZED. INSTEAD, A TYPE III ENDOLEAK DUE TO COMPONENT DISCONNECTION WAS IDENTIFIED BETWEEN THE TBE MAIN GRAFT AND A TBE EXTENDER. A SECOND EXTENDER WAS PLACED, BUT THIS DID NOT RESOLVE THE LEAK. THE PHYSICIAN THEN ELECTED TO USE A 9 × 7.5 CM VIABAHN TO EXTEND THE TBE SIDE BRANCH BACK INTO THE AORTA, FOLLOWED BY PLACEMENT OF A 37 × 10 GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIV

  Patient problems: Clinical Endoleak

  MAUDE report 25391555 ↗
• InjuryMay 6, 2026Device Endoleak

  ON (B)(6) 2026, THE PATIENT PRESENTED TO THE EMERGENCY ROOM (ER) WITH A TYPE B DISSECTION WITH LEFT LOWER EXTREMITY MALPERFUSION. THE PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE ON THE SAME DATE UTILIZING GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS (TBE). REPORTEDLY, THE PATIENT HAD AN ANGULATED BOVINE ARCH; HOWEVER, THE PATIENT HAD ADEQUATE ANATOMY FOR THE TBE DEVICE, AND THE DEVICE SIZING WAS ON-LABEL. IT WAS REPORTED THE TBE DEVICE (AORTIC COMPONENT) LANDED AND DEPLOYED ACCURATELY, BUT THEN THE PROXIMAL END OF THE DEVICE BIRD BEAKED ON THE INNER CURVE TOWARD THE BOVINE INNOMINATE ARTERY. THERE WAS NO CLEAR EVIDENCE OF AN ENDOLEAK ASSOCIATED WITH THE BIRD BEAKED TBE DEVICE, AND THE PHYSICIAN ELECTED TO LEAVE IT AS IS, DISCHARGING THE PATIENT WITHIN 48 HOURS. ON (B)(6) 2026, THE PATIENT RETURNED TO THE ER WITH CHEST PAIN. THE PATIENT RECEIVED A CT SCAN WHICH SHOWED A TYPE IA ENDOLEAK ON THE PROXIMAL END OF THE TBE DEVICE AND AN INTRAMURAL HEMATOMA (IMH) IN THE ASCENDING AORTA/AORTIC ARCH. THE ENDOLEAK IS SUSPECTED TO BE CAUSED BY THE BIRD BEAKING OF THE DEVICE DURING THE INITIAL IMPLANT, BUT THE CAUSE OF THE IMH IS UNKNOWN. ON (B)(6) 2026, THE PATIENT UNDERWENT OPEN REPAIR WHERE THE

  Patient problems: Chest Pain; Clinical Endoleak; Hematoma

  MAUDE report 25098627 ↗
• MalfunctionFeb 4, 2026Activation Failure

  ON (B)(6) 2026, THE PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE TO TREAT A PENETRATING AORTIC ULCER (PAU) JUST DISTAL TO THE LEFT SUBCLAVIAN ARTERY (LSA) UTILIZING A GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS (TAC083715A). REPORTEDLY, THE DEVICE WAS INSERTED INTO THE PATIENT, ADVANCED TO THE TARGET LOCATION, AND UPON PULLING THE DEPLOYMENT KNOB, THE DEVICE DID NOT DEPLOY. THE DEPLOYMENT LINE WOULD NOT RELEASE THE CONSTRAINED DEVICE. THE CAUSE OF THE DEPLOYMENT ISSUE IS UNKNOWN. THE DEVICE WAS REMOVED FROM THE PATIENT AND ANOTHER GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS WAS IMPLANTED SUCCESSFULLY. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24257508 ↗
• InjuryAug 4, 2025Device Endoleak; Device Endoleak

  THE FIELD SALES ASSOCIATE (FSA) REPORTED THE FOLLOWING TO GORE: ON (B)(6) 2025, 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. IT WAS REPORTED THAT A REINTERVENTION WAS PERFORMED ON (B)(6) 2025. THE PATIENT PRESENTED WITH A TYPE III ENDOLEAK LOCATED BETWEEN THE MAIN GRAFT AND THE AORTIC EXTENDER. AN ADDITIONAL AORTIC EXTENDER WAS SUCCESSFULLY IMPLANTED TO ADDRESS THE LEAK. THE PATIENT TOLERATED THE PROCEDURE. NO IMAGING IS AVAILABLE AT THIS TIME.

  Patient problems: Clinical Endoleak

  MAUDE report 22708656 ↗
• MalfunctionJun 5, 2025Difficult to Advance; Material Twisted/Bent; Activation Failure

  FROM STAFF: DURING A TBE (THORACIC BRANCHED ENDOPROSTHESIS) AAA (ARCH AORTIC ANGIOGRAM) THE SURGEON WAS INSERTING THE STENT THROUGH SHEATH AND AORTA. WHEN TRYING TO MANEUVER THE STENT AROUND THE BEND OF THE AORTA THE STENT/DEVICE BENT AND WAS UNABLE TO BE USED. THEREFORE, THE DEVICE WAS REMOVED FROM THE PATIENT AND NOT DEPLOYED. NO HARM WAS SEEN OR DONE TO THE PATIENT. NEW DEVICE WAS OPENED AND INSERTED. FROM OPERATIVE NOTE: THE LUNDERQUIST WAS ADVANCED THROUGH THE MAIN BODY OF THE GRAFT. THE GRAFT WAS ADVANCED OVER THE WIRES. IT DID NOT EASILY ADVANCED THROUGH THE UNCOVERED PORTION OF THE STENT GRAFT. THERE APPEARED TO BE SOME WIRE WRAP WHICH WAS RESOLVED BY REMOVING THE GRAFT FROM THE PATIENT. AGAIN WE ATTEMPTED TO ADVANCE THE GRAFT BUT IT WOULD NOT ADVANCE THROUGH THIS REGION SMOOTHLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22148693 ↗
• InjuryMar 27, 2025Device Endoleak; Device Endoleak

  ON (B)(6)2025, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF A THORACIC AORTIC ANEURYSM USING GORE® TAG® THORACIC BRANCH ENDOPROSTHESES. PRIOR TO THE PROCEDURE, THE PATIENT UNDERWENT A RIGHT CAROTID ARTERY TO SUBCLAVIAN ARTERY BYPASS FOR TREATMENT OF A LARGE KAVEREL'S DIVERTICULUM. A TAC083715A AORTIC COMPONENT WAS SUCCESSFULLY IMPLANTED. IT WAS REPORTED THAT IMAGES WERE REVIEWED ON (B)(6) 2025, AND CONTINUED PERFUSION WAS OBSERVED. IT WAS SUSPECTED THAT THERE WAS EITHER A PROXIMAL TYPE I OR TYPE II ENDOLEAK. A REINTERVENTION WILL BE PERFORMED BUT HAS NOT YET BEEN SCHEDULED.

  Patient problems: Clinical Endoleak

  MAUDE report 21704936 ↗
• InjuryJan 9, 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) 2024, THE PATIENT WAS IMPLANTED WITH GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS (TBE AC) TO TREAT BOTH A THORACIC DISSECTION WITH AN ANEURYSMAL COMPONENT. IT WAS REPORTED THAT THE PATIENT PRESENTED WITH A DISTAL TYPE I ENDOLEAK. A REINTERVENTION WAS PLANNED FOR (B)(6) 2024. THE REINTERVENTION HAS BEEN POSTPONED FOR A FUTURE DATE. THE EVENT IS ONGOING. THERE IS NO ANEURYSM SAC ENLARGEMENT. THE ROOT CAUSE OF THE ENDOLEAK IS UNKNOWN. IMAGES ARE NOT AVAILABLE. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Clinical Endoleak

  MAUDE report 21114484 ↗
• MalfunctionFeb 9, 2024Break; Break

  ON (B)(6) 2024, THE PATIENT WAS TREATED FOR A ZONE 2 AORTIC DISSECTION. THE PHYSICIAN IMPLANTED A GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS. MIDWAY THROUGH THE DEPLOYMENT, THE DEPLOYMENT STRING BROKE. IT WAS REPORTED THAT THE PHYSICIAN WAS PULLING THE STRING AT A 90° ANGLE AND CREATED FRICTION. IT CAUSED NO PATIENT HARM. THE LAST COUPLE STITCHES WERE RELEASED VIA CARDIAC PRESSURE FROM THE PATIENT AND THE CASE WAS COMPLETED WITHOUT INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18676673 ↗
• DeathFeb 8, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  FSA CALLED AND REPORTED THE FOLLOWING: ON (B)(6) 2023, THE PATIENT UNDERWENT A THORACIC ENDOVASCULAR PROCEDURE TO TREAT AN AORTIC INTRAMURAL HEMATOMA (IMH) THAT INVOLVED THE DESCENDING THORACIC AORTA AND LEFT SUBCLAVIAN ARTERY. THE GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS (TAC083715A, TSB081206A) WAS UTILIZED IN ZONE 2 TO TREAT THIS PATIENT. CT SCANS SHOWED THAT THE AORTA WAS DISEASED AROUND THE LEFT SUBCLAVIAN ARTERY. THE PHYSICIAN DECIDED TO LAND A PORTION OF THE TBE AORTIC COMPONENT IN PROXIMAL LANDING ZONE, WITHIN THE DISEASED TISSUE. PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2023, THE PHYSICIAN CALLED THE FSA AND REPORTED THAT THE PATIENT DEVELOPED AN ASCENDING IMH WHICH SHE BELIEVES CAUSED A STROKE AND RESULTED IN PATIENT DEATH. PHYSICIAN BELIEVES THERE MAY HAVE BEEN THROMBUS PRESENT IN THE ASCENDING AORTA ALTHOUGH IT WAS NOT DETECTABLE ON CT SCAN. PHYSICIAN ALSO SPECULATED THAT IT'S POSSIBLE THE ASCENDING IMH WAS INDUCED BY THE PROXIMAL END OF THE TAC083715A SINCE IT WAS LANDED IN DISEASED TISSUE. NO FURTHER PATIENT INFORMATION IS AVAILABLE. NO PATIENT IMAGES ARE AVAILABLE. CODE 1003-E:-NONE USED TO CAPTURE NO DEVICE ISSUE WAS IDENTIFIED.

  Patient problems: Stroke/CVA

  MAUDE report 18670972 ↗
• InjuryNov 28, 2023Positioning Failure; Positioning Failure

  FSA REPORTED: "FOLLOWING IVUS ASSESSMENT OF THE AORTIC ARCH AND ACCESS A DSF 2465 WAS PLACED IN A STANDARD MANNER OVER A LUNDERQUIST DOUBLE CURVE WIRE. THE FIRST TE37 WAS ADVANCED WITHOUT RESISTANCE. A PARALLEL WIRE AND FLUSH CATHETER WAS ADVANCED AND ANGIOGRAPHIC IMAGING WAS PERFORMED. THE CUFF WAS DEPLOYED WITH THE ¿BARE¿ PROXIMAL STENT PARTIALLY ACROSS THE LEFT CAROTID ARTERY. UPON RETRACTING THE TE CATHETER IT APPEARED THAT THE TE MOVED DISTAL APPROX. 3-5MM TO THE DISTAL MARGIN OF THE LEFT CAROTID. ANGIOGRAPHY WAS PERFORMED AND THERE APPEARED TO BE A PERSISTENCE TYPE 1A. BALLOONING WITH THE LARGE TRILOBE WAS PERFORMED. REPEAT ANGIOGRAPHY APPEARED TO ROW RESIDUAL, BUT POSSIBLY REDUCED, TYPE 1A ENDOLEAK. THE FLUSH CATHETER WAS REMOVED AND A SECOND TE37 WAS ADVANCED AND DEPLOYED WITH THE ¿BARE¿ PROXIMAL STENT ACROSS THE LEFT CAROTID ARTERY, FOLLOWING REPEAT ANGIOGRAPHY. UPON REMOVAL OF THE DELIVERY CATHETER IT APPEARED THAT THE SECOND TE37 MOVED DISTAL INTO APPROXIMATELY THE SAME POSITION AS THE FIRST TE37. TRI-LOBE BALLOONING WAS PERFORMED. ANGIOGRAPHY APPEARED TO SHOW PERSISTENT, BUT FURTHER REDUCED, TYPE 1A ENDOLEAK. THE PHYSICIAN ELECTED TO OBSERVE THE PT AND TO OBTAIN A FOLLO

  Patient problems: Clinical Endoleak

  MAUDE report 18222135 ↗
• InjurySep 20, 2023Patient-Device Incompatibility; Device Dislodged or Dislocated; Patient-Device Incompatibility; Device Dislodged or Dislocated

  ON (B)(6) 2023, PATIENT UNDERWENT TREATMENT FOR A THORACIC DISSECTION UTILIZING GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS (TBE-TAC083715A) AND GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL. FSA REPORTED PATIENT'S ANATOMY WAS PROBLEMATIC, WAS TOO SMALL, AND THERE WAS NO HEALTHY LANDING ZONE. PHYSICIAN WAS NOT ABLE TO OBTAIN A GOOD SEAL ON THE TBE DEVICE (TAC083715A) DURING INITIAL IMPLANT PROCEDURE. A TYPE 1 LEAK WAS IDENTIFIED AND PHYSICIAN DECIDED TO MONITOR THIS LEAK. ON AN UNKNOWN DATE, A CT SCAN WAS PERFORMED WHICH REVEALED THE SAME TYPE 1 ENDOLEAK, WITH NO CHANGES OR SIGNS OF IMPROVEMENT. ON (B)(6) 2023 PATIENT UNDERWENT REINTERVENTION SURGERY DUE TO THIS TYPE 1 ENDOLEAK. PATIENT TOLERATED PROCEDURE.

  Patient problems: Clinical Endoleak

  MAUDE report 17785508 ↗
• DeathJun 14, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  ON (B)(6)2023, THE PATIENT WAS TREATED FOR A THORACIC AORTIC ANEURYSM. IT WAS REPORTED THAT THERE WAS PRE-EXISTING THROMBOSIS. THE PHYSICIAN IMPLANTED A GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS AORTIC COMPONENT AND SIDE BRANCH COMPONENT. SHORTLY AFTER THE PROCEDURE, THE PATIENT SUFFERED A STROKE. THE PHYSICIAN RAN A CT SCAN AND ANGIOGRAM, AND THEN STENTED THE CAROTID ARTERY. THE PATIENT EXPIRED ON (B)(6)2023. IMAGES WERE RETURNED ROR EVALUATION.

  Patient problems: Stroke/CVA

  MAUDE report 17126352 ↗
• InjuryJun 12, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  ON (B)(6) 2023, THE PATIENT WAS TREATED FOR A ZONE 2 THORACIC AORTIC ANEURYSM. THE PHYSICIAN IMPLANTED A GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS AND GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS SIDE BRANCH. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2023, A TYPE IA ENDOLEAK WAS OBSERVED. THE PHYSICIAN THOUGHT THAT THE SOURCE WAS THE SIDE BRANCH AND IMPLANTED A GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2023, IT WAS SEEN THAT THE TYPE IA ENDOLEAK WAS STILL PRESENT. THE PHYSICIAN PLANS A REINTERVENTION ON THE GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS AORTIC COMPONENT.

  Patient problems: Clinical Endoleak

  MAUDE report 17107361 ↗
• InjuryDec 22, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2022, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR A ZONE 2 TYPE B DISSECTION AND WAS IMPLANTED WITH GORE® TAG® THORACIC BRANCH ENDOPROSTHESES (TBE). THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2022, THE PATIENT PRESENTED TO THE EMERGENCY ROOM WITH CHEST PAIN. TWO SEPARATE CT SCANS WERE PERFORMED AND SHOWED A TYPE A DISSECTION THE PATIENT UNDERWENT EMERGENCY SURGERY WHICH DETERMINED THE PROXIMAL END OF THE PARTIALLY UNCOVERED STENT APICES OF THE AORTIC COMPONENT HAD CREATED A RETROGRADE TYPE A DISSECTION. THE PHYSICIAN PERFORMED AN OPEN SURGICAL ARCH REPAIR AND SEWED DISTALLY TO THE TBE DEVICE TO REPLACE THE ASCENDING AORTA AND BYPASS THE HEAD VESSELS. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Vascular Dissection

  MAUDE report 16034792 ↗
• InjuryNov 28, 2022Difficult to Advance; Insufficient Device Problem Information; Activation Problem; Insufficient Device Problem Information

  ON (B)(6) 2022, THE PATIENT WAS REPORTEDLY ADMITTED FOR TREATMENT OF A PENETRATING ULCER IN THE AORTIC ARCH AND WAS IMPLANTED WITH GORE® TAG® THORACIC BRANCH ENDOPROSTHESES. AS REPORTED, THE PATIENT UNDERWENT A CAROTID TO SUBCLAVIAN ARTERY BYPASS. REPORTEDLY, THIS WAS PERFORMED TO PROVIDE A LANDING ZONE FOR A ZONE 2 DEPLOYMENT WITH THE SIDE BRANCH EXTENDING INTO THE LEFT SUBCLAVIAN ARTERY. AS REPORTED THE PHYSICIAN DEPLOYED THE GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS AORTIC COMPONENT WITHOUT HAVING THE SHEATH STABILIZED. AS REPORTED, THIS MADE THE AORTIC COMPONENT EXTEND FURTHER INTO THE LEFT SUBCLAVIAN THAN PLANNED. AS REPORTED, THE GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS BRANCH COMPONENT WAS LOADED ON THE THROUGH WIRE BEFORE THE AORTIC COMPONENT DELIVERY CATHETER WAS REMOVED. AS REPORTED, THIS WAS CORRECTED BY REMOVING BOTH CATHETERS. REPORTEDLY, AFTER VISUAL INSPECTION OF THE SIDE BRANCH COMPONENT, THERE WAS A TRANSITION FROM THE OLIVE TIP TO THE ENDOPROSTHESIS. AS REPORTED, THE PHYSICIAN THEN DECIDED TO OPEN A NEW GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS SIDE BRANCH COMPONENT. AS REPORTED, THIS WAS ADVANCED UP TO THE AORTIC COMPONENT WHERE THERE WERE SOME CHALLENGES TRACKI

  Patient problems: Stroke/CVA

  MAUDE report 15870079 ↗

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