GORE TAG Thoracic Branch Endoprosthesis TSB121706ARecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00733132654413), received between May 7, 2024 and Jun 5, 2026 — classified as 1 death, 7 injuries, 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (3 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. May 19, 2026Class IIOpen, Classified

   Due to catheter separation

   Z-2672-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 5, 2026Material Separation

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2026, THE PATIENT UNDERWENT THORACIC ENDOVASCULAR AORTIC REPAIR (TEVAR) FOR THE TREATMENT OF AN AORTIC DISSECTION INVOLVING ZONE 1 (LEFT COMMON CAROTID ARTERY) USING GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS DEVICES. IT WAS REPORTED THAT, UPON REMOVAL OF A GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS (TBE) SIDE BRANCH (SB) COMPONENT DELIVERY CATHETER, THE LEADING OLIVE OF THE DELIVERY CATHETER SEPARATED FROM THE MAIN CATHETER SHAFT. IT WAS FURTHER REPORTED THAT THE ANATOMY WAS NOT SIGNIFICANTLY TORTUOUS, WITH ONLY MINOR NARROWING OF THE AORTIC ARCH. THE USER REPORTED NO EXCESSIVE FORCE, TWISTING, OR DIFFICULT MANIPULATION DURING DEVICE USE, AND STATED THAT THE PROCEDURE WAS OTHERWISE STRAIGHTFORWARD. FOLLOWING IDENTIFICATION OF THE SEPARATION, AN INITIAL ATTEMPT TO RETRIEVE THE SEPARATED COMPONENT USING A SNARE WAS UNSUCCESSFUL. THE DEVICE FRAGMENT WAS SUBSEQUENTLY RETRIEVED VIA ARM ACCESS USING A LONG CATHETER TO ADVANCE THE SEPARATED COMPONENT OUT THROUGH THE 20 FR SHEATH. THERE WERE NO REPORTED PATIENT COMPLICATIONS OR ADVERSE CLINICAL OUTCOMES ASSOCIATED WITH THIS EVENT, AND THE PATIENT REMAINED STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25415178 ↗
• InjuryFeb 19, 2026Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2026, PATIENT UNDERWENT A THORACIC ENDOVASCULAR AORTIC REPAIR (TEVAR) TO TREAT AN ANEURYSM IN THE TRANSVERSE ARCH UTILIZING A GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS (TBE - AORTIC COMPONENT AND SIDE BRANCH). REPORTEDLY, PATIENT FIRST UNDERWENT A CAROTID-CAROTID ARTERY BYPASS AND A SUBCLAVIAN-CAROTID ARTERY BYPASS. AFTER THAT, THE LEFT COMMON CAROTID ARTERY WAS LIGATED SURGICALLY PRIOR TO TBE GRAFTS BEING IMPLANTED AND THE LEFT SUBCLAVIAN ARTERY WAS OPEN DURING THE TBE GRAFT PLACEMENT. AFTER THE GRAFTS WERE IMPLANTED, THE LEFT SUBCLAVIAN ARTERY WAS OCCLUDED WITH AN AMPLATZER PLUG AS PART OF THE PLANNED COVERAGE BY THE PHYSICIAN. THE OVERALL PROCEDURE WENT WELL WITH DEPLOYMENT OF THE TBE GRAFTS AND PATIENT'S NEURO SIGNS STAYED NORMAL DURING PROCEDURE. ON (B)(6) 2026, FIELD SALES ASSOCIATE WAS NOTIFIED BY PHYSICIAN THAT PATIENT HAD A MINOR STROKE. A CT SCAN WAS DONE WHICH RULED OUT A MAJOR STROKE AND PHYSICIAN SUSPECTS THE CAUSE OF THE MINOR STROKE IS DUE TO THE MICRO EMBOLISM THAT MAY HAVE BEEN DISLODGED DURING PASSING OF THE WIRES INTO THE ARCH AND THE ASCENDING AORTA. PATIENT INITIALLY COULDN'T MOVE THEIR ARMS BUT HAS GOT MOTOR MOVEME

  Patient problems: Embolism/Embolus; Paralysis; Stroke/CVA

  MAUDE report 24389446 ↗
• DeathFeb 8, 2026Insufficient Device Problem Information

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE THROUGH THE PIVOTAL STUDY FOR THE GORE® ASCENDING STENT GRAFT IN THE TREATMENT OF DISSECTIONS OF THE ASCENDING AORTA (AAA-2402): ON (B)(6) 2025, THE SUBJECT WAS TO BE IMPLANTED WITH THE INVESTIGATIONAL GORE® ASCENDING STENT GRAFT. A GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS (AORTIC COMPONENT AND SIDE BRANCH) WAS ALSO IMPLANTED DURING THE PROCEDURE. ON THE SAME DAY OF THE PROCEDURE, (B)(6) 2025, THE PATIENT HAD A BASILAR ARTERY STROKE THAT RESULTED IN DEATH. THE CAUSE OF THE STROKE AND DEATH ARE UNKNOWN.

  Patient problems: Stroke/CVA

  MAUDE report 24288378 ↗
• InjuryFeb 6, 2026Adverse Event Without Identified Device or Use Problem

  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 (B)(6) AND THE AORTA HAD GOTTEN PROGRESSIVELY WORSE. THE PHYSICIAN DOES NOT KNOW IF THERE WAS UNDETECTED INFECTION AT THE TIME OF THE INDEX PRO

  Patient problems: Post Operative Wound Infection

  MAUDE report 24282846 ↗
• 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 23469648 ↗
• InjuryOct 28, 2024Fracture; Premature Activation; Malposition of Device; Fracture; Premature Activation; Malposition of Device

  ON (B)(6) 2024, PATIENT UNDERWENT AN OFF LABEL ENDOVASCULAR PROCEDURE TO TREAT A DISSECTION UTILIZING GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS (TSB121706A -SIDE BRANCH COMPONENT AND TAC123715A-AORTIC COMPONENT). DURING THE PROCEDURE, THE TBE AORTIC COMPONENT WAS IMPLANTED IN A MISALIGNED MANNER, DUE TO TORTUOUS ANATOMY. THE PORTAL OF THE TAC123715A DEVICE, COULD NOT GET ALIGNED CORRECTLY, SO WHEN THE AORTIC COMPONENT OPENED, THE PORTAL WAS ON THE INFERIOR CURVE, WHICH MADE IT DIFFICULT TO ADVANCE THE SIDE BRANCH THROUGH IT. THE PHYSICIAN WAS TORQUEING THE SIDE BRANCH TO GET IT THROUGH THE PORTAL. AS A RESULT OF THE TORQUEING, THE NOSE CONE AND PART OF THE DELIVERY CATHETER BROKE OFF FROM THE REST OF THE DELIVERY SYSTEM. ADDITIONALLY, THE SIDE BRANCH WAS PREMATURELY DEPLOYED IN THE DESCENDING THORACIC AORTA , AND NOT IN THE PORTAL. PHYSICIAN HAD TO SURGICALLY REMOVE THE NOSE CONE AND BROKEN PORTION OF THE DELIVERY CATHETER. PATIENT ALREADY HAD A CUT DOWN AS THERE WAS BRACHIAL ACCESS, BUT THEY HAD TO MAKE THE CUTDOWN BIGGER, IN ORDER TO PULL OUT THE NOSE CONE AND PART OF THE DELIVERY SYSTEM. THE REST OF THE SIDE BRANCH COMPONENT STAYED BEHIND IN THE PATIENT'S BODY, AND WAS PINNED BE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20546597 ↗
• InjuryMay 17, 2024Device Endoleak; Device Endoleak

  ON (B)(6) 2024, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN ASCENDING AORTIC ANEURYSM IN THE ASG22-02 ARISE II PIVOTAL STUDY USING GORE® ASCENDING STENT GRAFTS AND GORE® TAG® THORACIC BRANCH ENDOPROSTHESES (TBE). TWO TBE SIDE BRANCH COMPONENTS WERE IMPLANTED IN THE PATIENT'S BRACHIOCEPHALIC ARTERY. ON (B)(6) 2024, A TYPE IC ENDOLEAK WAS OBSERVED. A GORE® EXCLUDER® AAA CONTRALATERAL LEG COMPONENT WAS IMPLANTED IN THE PATIENT'S BRACHIOCEPHALIC ARTERY AND INTO THE TBE PORTAL. ON (B)(6) 2024, THE PATIENT WAS DISCHARGED. THERE WERE NO FURTHER REPORTED ISSUES.

  Patient problems: Clinical Endoleak

  MAUDE report 19347098 ↗
• InjuryMay 16, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  ON (B)(6) 2024, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AN ASCENDING AORTIC ANEURYSM. THE PATIENT WAS IMPLANTED WITH GORE® TAG® THORACIC BRANCH ENDOPROSTHESES (TBE) IN ZONE 0 AND WITH A PROXIMAL EXTENSION INTO THE ASCENDING AORTA USING GORE® TAG® CONFORMABLE THORACIC STENT GRAFTS (CTAG). THE PATIENT TOLERATED THE PROCEDURE. THE TBE SIDE BRANCH DEVICES WERE IMPLANTED WITHIN THE BRACHIOCEPHALIC ARTERY. ON (B)(6) 2024, THE PHYSICIAN REPORTED THE PATIENT HAD A PSEUDOANEURYSM AT THE DISTAL END OF THE SIDE BRANCH DEVICES. ONSET DATE IS UNKNOWN, PHYSICIAN SUSPECTS THE PATIENT MAY HAVE DEVELOPED AN INFECTION, BUT THIS HAS NOT BEEN CONFIRMED. ON (B)(6) 2024, IT WAS REPORTED THAT THE PATIENT IS BELIEVED TO HAVE ALSO DEVELOPED A SMALL PENETRATING AORTIC ULCER (PAU) IN THE ASCENDING AORTA PROXIMAL TO THE CTAG DEVICE. THE FSA IS NOT AWARE OF ANY PLANNED INTERVENTION TO TREAT THIS PAU. ON (B)(6) 2024, THE PATIENT UNDERWENT ENDOVASCULAR REINTERVENTION FOR TREATMENT OF THE PSEUDOANEURYSM AT THE DISTAL END OF THE SIDE BRANCH DEVICE. AN ADDITIONAL GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS SIDE BRANCH WAS IMPLANTED IN THE BRACHIOCEPHALIC ARTERY. THE PATIENT TOLERATED THE PROCEDURE WITH GOOD

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

  MAUDE report 19337696 ↗
• InjuryMay 7, 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 FOR THIS. 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. THE CAUSE OF LEFT PRECENTRAL GYRUS REMAINS UNKNOWN.

  Patient problems: Stroke/CVA

  MAUDE report 19264460 ↗