GORE TAG Thoracic Branch Endoprosthesis TAC084015ARecalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00733132654130), received between Nov 4, 2022 and Mar 31, 2026 — classified as 7 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 31, 2026Material Separation

  THE FIELD SALES ASSOCIATE (FSA) REPORTED THE FOLLOWING TO GORE: ON (B)(6) 2025, THE PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE TO TREAT A DISSECTION USING THE GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS (TBE) AND A VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX). DURING THE CASE, THE AORTIC COMPONENT OF THE TBE WAS DEPLOYED TOO PROXIMALLY, AND THE PHYSICIAN ATTEMPTED TO REPOSITION IT USING A TRILOBE BALLOON. THIS MANEUVER TEMPORARILY COVERED TWO THIRDS OF THE PATIENT¿S BOVINE INNOMINATE ARTERY, THOUGH BLOOD FLOW REMAINED ADEQUATE. THE PATIENT ALSO HAD AN EARLY LEFT VERTEBRAL ARTERY TAKEOFF, AND TO MAINTAIN PERFUSION TO THE VERTEBRAL ARTERY, THE PHYSICIAN POSITIONED PART OF THE SIDE BRANCH OUTSIDE THE TBE PORTAL WITHIN THE AORTIC COMPONENT. THIS RESULTED IN AN IMPERFECT SEAL INTO THE LEFT SUBCLAVIAN ARTERY. AN INTRAOPERATIVE ENDOLEAK WAS VISUALIZED, AND AN 11 MM VBX WAS IMPLANTED IN AN ATTEMPT TO RESOLVE IT. ALTHOUGH THE COMPLETION ANGIOGRAM DID NOT DEMONSTRATE A REMAINING ENDOLEAK, A 30 DAY CT IDENTIFIED A TYPE 1B ENDOLEAK. ON (B)(6) 2026, THE PATIENT RETURNED FOR TREATMENT OF THE KNOWN TYPE 1B ENDOLEAK, AND THE SIDE BRANCH WAS EXTENDED USING ANOTHER TBE SIDE BRANCH AND GORE® T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24748895 ↗
• InjuryFeb 2, 2026No Apparent Adverse Event

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2026, A PATIENT WAS TREATED FOR A ZONE 2 THORACIC AORTIC ANEURYSM USING A GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS (TBE) SYSTEM. WHEN THE TBE AORTIC COMPONENT WAS ADVANCED, THE PHYSICIAN WAS UNABLE TO ROTATE THE DEVICE. THE PHYSICIAN ATTEMPTED A FEW TIMES TO REPOSITION, BUT EVENTUALLY STOPPED BECAUSE HE DID NOT WANT TO MAKE MORE PASSES IN THE ARCH. THE PHYSICIAN DECIDED TO DEPLOY WITH THE PORTAL ON THE INNER CURVE. A SIDE BRANCH COMPONENT WAS ADVANCED AND DEPLOYED, BUT A SECOND SIDE BRANCH WAS UNABLE TO BE TRACKED INTO POSITION, SO IT WAS DISCARDED, AND A GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS WAS USED INSTEAD. ON WEDNESDAY, (B)(6), THE PATIENT WAS DIAGNOSED WITH BILATERAL STROKES. THE PATIENT HAS BEEN PLACED IN COMFORT CARE, AND NO TREATMENT IS PLANNED AT THIS TIME. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Stroke/CVA

  MAUDE report 24234566 ↗
• InjuryJan 2, 2026Device Endoleak

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2025 A PATIENT WAS TREATED FOR A DISSECTION USING A GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS. ON (B)(6) 2025, THE PATIENT WAS TREATED FOR A DISSECTION USING A GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE) SYSTEM, INCLUDING GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS DEVICES. ON FOLLOW-UP CT, THE PHYSICIAN NOTED A PROXIMAL ENDOLEAK ON THE TBE DEVICE. ON (B)(6) 2025, A REINTERVENTION OCCURRED. A TBE EXTENDER WAS PLACED PROXIMALLY OF THE TBE DEVICE.

  Patient problems: Clinical Endoleak

  MAUDE report 23949699 ↗
• InjuryJul 22, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  THE FSA REPORTED THE FOLLOWING TO GORE: ON (B)(6) 2025, THE PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE UTILIZING THE GORE® DRYSEAL FLEX INTRODUCER AND GORE® TAG® THORACIC BRANCH ENDOPROSTHESES (AORTIC AND SIDE BRANCH COMPONENT) IN ZONE 2. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2025, THE FSA WAS INFORMED THAT THE PATIENT DEVELOPED A RETROGRADE TYPE A DISSECTION. ACCORDING TO THE PHYSICIAN, IT APPEARED THAT THE UNCOVERED STENT PORTION HAD ERODED THROUGH THE AORTA. THE DISSECTION EXTENDED FROM THE CAROTID ARTERY TO THE PROXIMAL END OF THE DEVICE AND THEN RETROGRADE INTO THE ASCENDING AORTA. AN OPEN SURGICAL REPAIR OF THE AORTIC ARCH WAS PERFORMED. THE PATIENT TOLERATED THE PROCEDURE. THE PHYSICIAN ATTRIBUTED THE DISSECTION AND EROSION TO THE UNCOVERED STENT PORTION OF THE DEVICE.

  Patient problems: Erosion; Vascular Dissection

  MAUDE report 22569030 ↗
• InjuryFeb 18, 2025Migration; Migration

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2025, A PATIENT WAS TREATED FOR A ZONE 2 THORACIC ANEURYSM USING THE GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS (TBE) SYSTEM. THE AORTIC COMPONENT WAS SUCCESSFULLY DEPLOYED. WHILE ADVANCING THE SIDE BRANCH, THE PORTAL MOVED POSTERIOR. THIS LED TO THE DEVICE LOSING PROXIMAL SEAL, AND THE DEVICE MIGRATED DISTALLY ABOUT 6-7CM. THE SIDE BRANCH WAS DEPLOYED, BUT A SECOND SIDE BRANCH WAS REQUIRED. ADDITIONALLY, THE TBE WAS EXTENDED PROXIMALLY WITH A GORE® TAG® CONFORMABLE THORACIC STENT GRAFT (CTAG). ON THE COMPLETION ANGIOGRAM, A TYPE III ENDOLEAK WAS NOTICED BETWEEN THE AORTIC COMPONENT AND A BRANCH COMPONENT OF THE TBE. A REINTERVENTION IS PLANNED TO EXTEND THE PORTAL WITH ANOTHER SIDE BRANCH COMPONENT. REPORTEDLY THE STEEP ANGLE OF THE LSA TO THE AORTIC ARCH LIKELY CAUSED THE ISSUE.

  Patient problems: Clinical Endoleak

  MAUDE report 21400209 ↗
• InjuryOct 2, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON (B)(6) 2023, PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE TO TREAT A ZONE-2 TYPE-B THORACIC DISSECTION UTILIZING GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS. ON (B)(6) 2024, DURING A CT SCAN, A TYPE 1A ENDOLEAK WAS OBSERVED. ON (B)(6) 2024, PATIENT UNDERWENT A REINTERVENTION SURGERY TO TREAT THIS TYPE 1A ENDOLEAK. ON 9/5/2024, FSA BECAME AWARE OF THIS REINTERVENTION SURGERY. PHYSICIAN PLACED MULTIPLE PENUMBRA COILS BEHIND THE GRAFT OUT TOWARDS THE TRANSVERSE ARCH. ENDOLEAK WAS RESOLVED. PATIENT TOLERATED THE PROCEDURE. THE CAUSE OF THE ENDOLEAK REMAINS UNKNOWN, AND NO FURTHER PATIENT INFORMATION IS CURRENTLY AVAILABLE.

  Patient problems: Clinical Endoleak

  MAUDE report 20351299 ↗
• MalfunctionSep 27, 2024Break; Break

  THE FSA REPORTED THE FOLLOWING TO GORE: ON (B)(6) 2024, THE PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE TO TREAT AN ANEURYSM UTILIZING THE GORE® TAG® THORACIC BRACH ENDOPROSTHESIS IN ZONE 3. THE PHYSICIAN ATTEMPTED TO ADVANCE THE TBE AND FELT A ¿POP¿ GOING THROUGH THE SHEATH. AT THAT TIME, THE PHYSICIAN SUGGESTED THAT IT WAS POSSIBLE A DEPLOYMENT LINE BREAK. THE PHYSICIAN DECIDED TO RETRACT THE TBE BECAUSE HE DID NOT FEEL COMFORTABLE USING THE TBE. ANOTHER TBE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE PATIENT TOLERATED THE PROCEDURE. THE PHYSICIAN IS NOT SURE WHAT CAUSED THE ISSUE AS HE IS NOT SURE IF THE DEPLOYMENT LINE BROKE. IN HIS EXPERIENCE OF IMPLANTING NUMEROUS DEVICES, HE BELIEVES THAT THE "POP" HAD TO HAVE BEEN THE DEPLOYMENT LINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20322892 ↗
• InjurySep 17, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  THE FSA REPORTED THE FOLLOWING TO GORE: ON (B)(6) 2024, THE PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE TO TREAT A CHRONIC TYPE B DISSECTION UTILIZING THE GORE® DRYSEAL FLEX INTRODUCER AND GORE® TAG® THORACIC BRANCH ENDOPROSTHESES (AORTIC AND SIDE BRANCH COMPONENT). THE PATIENT TOLERATED THE PROCEDURE. ITS WAS REPORTED THAT AT THE TIME OF THE (B)(6) PROCEDURE, THE PHYSICIAN FELT THAT THE PRIMARY ENTRY TEAR WAS COVERED. HOWEVER, ON AUGUST 19TH, 2024, THE PATIENT COMPLAINED OF BACK PAIN AND RECEIVED A CT. THE PHYSICIAN DECIDED TO TAKE THE PATIENT INTO SURGERY. A DACRON GRAFT WAS SOWN IN THE ASCENDING AORTA TO THE GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS AND THEN THE PHYSICIAN PERFORMED A BYPASS FROM THE ASCENDING GRAFT TO THE INNOMINATE AND CAROTID ARTERY. AN ENDOLEAK WAS PRESENT AND IT WAS DETERMINED TO LEAVE IT ALONE. IT MAY NEED TO BE TREATED IN THE FUTURE. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Clinical Endoleak; Pain

  MAUDE report 20238092 ↗
• MalfunctionOct 16, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2023, THE PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE TO TREAT AN AORTIC ANEURYSM IN ZONE 1-INNOMINATE ARTERY (BOVINE ARCH) UTILIZING A GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS. REPORTEDLY, DURING THE PROCEDURE, THERE WAS A LOT OF MANIPULATION DUE TO TORTUOUS PATIENT ANATOMY IN THE THORACIC AORTA WITH THE DEVICE AND MULTIPLE WIRE WRAPS, AND THERE WAS A LOT OF MOVEMENT. AFTER FEW ATTEMPTS OF TAKING THE DEVICE BACK OUT AND PUTTING IT BACK IN THE SHEATH, IT WAS NOTICED THE DISTAL PART OF THE STENT TOWARDS THE CATHETER SEEMED TO BE TWISTED, DOCTOR TRIED TO UNTWIST, AND REINSERTED THE DEVICE AND TRIED REPOSITIONING FEW TIMES AS WELL. IT WAS THEN UNDER FLURO, THE PHYSICIAN SAW THAT THE PROXIMAL PORTION OF THE GRAFT BECAME APART/DISENGAGED FROM THE OLIVE TIP. PHYSICIAN THEN REMOVED THE DEVICE AND USED A REPLACEMENT DEVICE TO COMPLETE THE PROCEDURE. PATIENT IS DOING OKAY. THE DEVICE IS BEING SENT BACK TO GORE FOR AN EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17940792 ↗
• InjuryNov 4, 2022Patient Device Interaction Problem; Patient Device Interaction Problem

  ON (B)(6) 2022, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF A ZONE 2 THORACIC AORTIC DISSECTION USING GORE® TAG® THORACIC BRANCH ENDOPROSTHESES (TBE). IT WAS REPORTED THAT THERE WERE NO ISSUES OBSERVED UPON CLOSE OF THE PROCEDURE. THE PROXIMAL LANDING ZONE OF THE TBE DEVICE WAS REPORTEDLY FREE FROM DISSECTION. ON OR AROUND (B)(6) 2022, THE PATIENT PRESENTED TO THE FACILITY COMPLAINING OF CHEST PAIN. IT WAS REPORTEDLY DETERMINED THAT THE BARE STENT ROW OF THE PROXIMAL END OF THE TBE AORTIC COMPONENT HAD TORN INTO THE PATIENT'S AORTA. REPORTEDLY THE DISSECTION NOW EXTENDED INTO THE PATIENT'S ASCENDING AORTA CREATING A RETROGRADE TYPE A DISSECTION. IT WAS REPORTED THAT, ON (B)(6) 2022, THE PATIENT UNDERWENT REINTERVENTION. THE PHYSICIAN ATTEMPTED TO PLACE A TBE AORTIC EXTENDER COMPONENT PROXIMALLY. HOWEVER, THERE WAS REPORTEDLY NO ROOM FOR THE DEVICE AND THE PHYSICIAN INSTEAD PERFORMED A TOTAL ARCH REPAIR WITH A DACRON GRAFT VIA MEDIAN STERNOTOMY. THE DISTAL END OF THE DACRON GRAFT WAS SEWN INTO THE TBE AORTIC COMPONENT ON THE TBE DEVICE'S PROXIMAL END. THERE WERE NO FURTHER REPORTED ISSUES. THE PATIENT TOLERATED THE REINTERVENTION.

  Patient problems: Chest Pain; Vascular Dissection

  MAUDE report 15740388 ↗

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