GORE TAG Thoracic Branch Endoprosthesis TSB121506ARecalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00733132654406), received between Oct 11, 2022 and Feb 4, 2026 — classified as 1 death, 6 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Positioning Failure” (2 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 4, 2026Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2026, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR A DISSECTION IN ZONE 2 OF THE THORACIC AORTA AND WAS IMPLANTED WITH GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS DEVICES. THE PATIENT TOLERATED THE PROCEDURE WITH GOOD RESULTS. ON (B)(6)2026, IT WAS REPORTED THAT THE PATIENT EXPERIENCED PARAPARESIS AND UNDERWENT PLACEMENT OF A SPINAL DRAIN. ON (B)(6) 2026, IT WAS REPORTED THAT THE PATIENT IS DOING MUCH BETTER.

  Patient problems: Paresis

  MAUDE report 24261330 ↗
• InjuryMar 25, 2025Device Endoleak; Device Endoleak

  ON (B)(6) 2025, PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE UTILIZING GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS. ON 2/26/2025, FSA WAS NOTIFIED AN ENDOLEAK WAS OBSERVED FROM THE SIDE BRANCH COMPONENT IN THE LEFT SUBCLAVIAN ARTERY. IT WAS ALSO REPORTED THE SIDE BRANCH WAS NOT EXTENDED FAR ENOUGH DISTALLY DURING THE INITIAL IMPLANT PROCEDURE. THE PHYSICIAN PLANS TO BRING THE PATIENT BACK FOR REINTERVENTION SURGERY ON (B)(6) 2025. PHYSICIAN PLANS TO EXTEND DISTALLY INTO THE LEFT SUBCLAVIAN ARTERY TO GAIN SEAL. NO FURTHER PATIENT INFORMATION IS AVAILABLE.

  Patient problems: Clinical Endoleak

  MAUDE report 21688652 ↗
• MalfunctionJan 3, 2025Fracture; Fracture

  PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE TO TREAT A THORACIC ANEURYSM, UTILIZING TBE. THE TBE AORTIC COMPONENT AND SIDE BRANCH COMPONENT WERE DEPLOYED WITH NO ISSUES. UPON REMOVING THE DELIVERY CATHETER FOR THE SIDE BRANCH COMPONENT, IT WAS OBSERVED THE OLIVE TIP BROKE OFF AND REMAINED IN THE SUBCLAVIAN ARTERY. PHYSICIAN DID NOT NOTE ANY PRESSURE OR FRICTION UPON REMOVAL OF DELIVERY CATHETER. THE OLIVE TIP WAS SUCCESSFULLY REMOVED WITH NO PATIENT HARM OBSERVED. THE CAUSE OF THE ISSUE REMAINS UNKNOWN. NO ANATOMICAL CHALLENGES WERE NOTED. THE DELIVERY CATHETER AND OLIVE TIP WERE DISCARDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21072778 ↗
• MalfunctionOct 28, 2024Activation Problem; Activation Problem

  THE FOLLOWING WAS REPORTED: ON (B)(6) 2024, PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE TO TREAT A THORACIC ANEURYSM UTILIZING GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS IN ZONE 2. THE PHYSICIAN IMPLANTED THE TBE AORTIC COMPONENT WITH THE PORTAL MISALIGNED, DUE TO SOME STRUGGLES GETTING ALL THE WIRE WRAP OUT OF THE AORTIC COMPONENT. AS A RESULT, THE AORTIC COMPONENT WAS IMPLANTED MORE ANTERIOR THAN INTENDED. UPON TRYING TO DEPLOY THE SIDE BRANCH COMPONENT, THERE WAS SOME RESISTANCE FELT WHEN TRYING TO DEPLOY THE DEVICE. THE DEVICE HAD BEEN ADVANCED WITH SIGNIFICANT FORCE THROUGH THE TBE PORTAL AND INTO THE LSA. IN ADDITION, UPON PULLING THE DEPLOYMENT STRING, THE SIDE BRANCH GRAFT WOULD NOT OPEN AT ALL. SINCE THERE WAS RESISTANCE AND THE SIDE BRANCH GRAFT WOULD NOT OPEN UPON PULLING THE DEPLOYMENT STRING, ANOTHER TBE SIDE BRANCH COMPONENT WAS USED TO COMPLETE THE PROCEDURE. THE PATIENT TOLERATED THE PROCEDURE. NO FURTHER PATIENT INFORMATION OR IMAGES ARE AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20550052 ↗
• InjuryOct 3, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  ON (B)(6) 2024, THE PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE TO TREAT AN ANEURYSM UTILIZING THE GORE® TAG® THORACIC BRANCH ENDOPROSTHESES AND GORE® DRYSEAL FLEX INTRODUCER SHEATH IN ZONE 3. THE TBE PROCEDURE WAS COMPLETED WITH NO COMPLICATIONS. THE GRAFT WAS PLACED WELL AND THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2024, THE PATIENT EXPERIENCED A STROKE. THE PHYSICIAN DOES NOT KNOW WHAT CAUSED THE EVENT TO OCCUR.

  Patient problems: Ischemia Stroke

  MAUDE report 20362060 ↗
• DeathNov 30, 2023Positioning Failure; Positioning Failure

  ON (B)(6), 2023, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR A THORACIC AORTIC DISSECTION AND PENETRATING AORTIC ARCH ULCER AND WAS IMPLANTED WITH GORE® TAG® THORACIC BRANCH ENDOPROSTHESES (TBE). AN OPEN SURGICAL PROCEDURE WAS NOT AN OPTION DUE TO PATIENT CONDITION AND ACCESS WAS OBTAINED IN THE ABDOMINAL AORTA. THE PATIENT HAD PREVIOUSLY RECEIVED A PROCEDURE TO BYPASS THE LSA TO THE LCCA AND BCA. THE PATIENT HAD AN EXISTING CABG COMING OFF THE MID-BCA AND A LIMA BYPASS OFF THE LSA. PRIOR TO PLACEMENT OF TBE, THE PATIENT WAS HYPOTENSIVE WITH INCREASED PRESSURE IN THE LEFT ARM COMPARED TO THE RIGHT. THE TBE WAS PLACED WITH THE SIDE BRANCH IN THE LSA AND WITH INTENTIONAL PARTIAL COVERAGE OF THE BCA PROXIMALLY WITH THE AORTIC COMPONENT (AC). IT WAS REPORTED THAT THE PORTAL OPENING ON THE GORE® TAG® AORTIC COMPONENT (TAC123715A/25765796) HAD LANDED SLIGHTLY DISTAL TO THE LSA, LEAVING PLACEMENT OF THE SIDE BRANCH (TSB121506A/26679693) A LITTLE COMPRESSED. POST OPERATIVE CTA DEMONSTRATED A MODERATE STENOSIS IN THE COMPRESSED PORTION OF THE SIDE BRANCH. A GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM (TGMR373710/23079450) WAS PLACED PROXIMALLY TO THE TAC TO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18242586 ↗
• InjuryNov 28, 2023Material Deformation; Material Deformation

  ON (B)(6) 2023, THE PATIENT WAS TREATED FOR AN AORTIC DISSECTION. THE PHYSICIAN IMPLANTED A GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS SIDE BRANCH COMPONENT AND GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS AORTIC COMPONENT. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2023, THE PATIENT SUFFERED A TIA. THE PHYSICIAN IMPLANTED A VBX INSIDE THE SIDE BRANCH COMPONENT, AND THE PATIENT TOLERATED THE PROCEDURE. IT IS BELIEVED THAT THE SIDE BRANCH COMPONENT HAD BECOME KINKED, ALTHOUGH IT WAS PATENT AT THE CONCLUSION OF THE INDEX PROCEDURE.

  Patient problems: Transient Ischemic Attack

  MAUDE report 18222713 ↗
• InjuryAug 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON AN UNKNOWN DATE, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF A ZONE 3 THORACIC AORTIC ANEURYSM AT AN OUTSIDE FACILITY. AN ANEURYSM DEVELOPED PROXIMAL TO THE TREATMENT AREA IN THE PATIENT'S AORTIC ARCH. ON (B)(6), 2023, A ZONE 0 ENDOVASCULAR TREATMENT OF THE AORTIC ARCH ANEURYSM WAS PERFORMED USING GORE® TAG® THORACIC BRANCH ENDOPROSTHESES AND A GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM. IT WAS REPORTED THAT THE PATIENT EXPERIENCED A STROKE POST-OPERATIVELY ON THE SAME DAY. THE CURRENT PATIENT STATUS REMAINS UNAVAILABLE.

  Patient problems: Stroke/CVA

  MAUDE report 17592790 ↗
• MalfunctionAug 10, 2023Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT THE ENCODE EMERGENCE IS MORE DIFFICULT TO SEAT PROPERLY. DOCTOR FEELS THERE IS A CHANGED HEX TOLERANCE BETWEEN THE ORIGINAL ENCODE AND ENCODE EMERGENCE. THE EMERGENCE TOLERANCE SEEMS TO BE TIGHTER AND MORE DIFFICULT TO SEAT. THE DOCTOR ESTIMATED THE GROUP HAS HAD MORE THAN 30 CASES WHERE SEATING IS AN ISSUE SINCE LAUNCH. CONTACTED CUSTOMER AND SALES REP FOR ADDITIONAL INFORMATION BUT NEITHER HAD ANY SPECIFICS REGARDING PREVIOUS OCCURRENCES BESIDES THAT THEY WERE ABLE TO COMPLETE THE PROCEDURES EITHER BY BACKING THE SCREW SLIGHTLY TO GET THE ABUTMENT TO SEAT PROPERLY OR REPLACING IT WITH THE ORIGINAL ENCODE.

  Patient problems: Vascular Dissection

  MAUDE report 17499258 ↗
• InjuryApr 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FIELD SALES ASSOCIATE (FSA) REPORTED THE FOLLOWING:IT WAS REPORTED ON (B)(6) 2023, DURING AN ENDOVASCULAR PROCEDURE THAT THE PHYSICIAN WAS HAVING DIFFICULTY ALIGNING THE GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS AORTIC COMPONENT TO THE OSTIUM OF THE LEFT SUBCLAVIAN ARTERY. IT WOULD NOT ROTATE TO ALIGN TO OSTIUM. THERE WAS DIFFICULTY TRACKING THIS DEVICE AROUND THE AORTIC ARCH.THE PHYSICIAN ABORTED THE BRANCHED PROCEDURE AND PROCEEDED WITH COVERING THE LEFT SUBCLAVIAN ARTERY.

  Patient problems: Vascular Dissection

  MAUDE report 16727107 ↗
• MalfunctionOct 11, 2022Loss of or Failure to Bond; Improper or Incorrect Procedure or Method; Loss of or Failure to Bond; Improper or Incorrect Procedure or Method

  ON (B)(6), 2022, THE PATIENT UNDERWENT EMERGENCY TREATMENT OF A SYMPTOMATIC ZONE 0 DISSECTING ANEURYSM USING GORE® TAG® THORACIC BRANCH ENDOPROSTHESES (TBE). IT WAS REPORTED THAT A 6FR. NON-GORE COOK MEDICAL INTRODUCER SHEATH WAS USED FOR RIGHT BRACHIAL ACCESS, AND A THROUGH-AND-THROUGH WIRE WAS PLACED FOR DISTAL ACCESS AT THE PATIENT'S FEMORAL ARTERY. THE AORTIC COMPONENT WAS IMPLANTED WITH NO REPORTED ISSUES AND THE SIDE BRANCH COMPONENT WAS ADVANCED. THE PATIENT'S ANATOMY WAS REPORTED TO BE EXTENSIVELY TORTUOUS. AS DEPLOYMENT OF THE SIDE BRANCH DEVICE WAS INITIATED, RESISTANCE WAS REPORTED. IT WAS OBSERVED THAT THE DILATOR OF THE COOK MEDICAL INTRODUCER SHEATH HAD NOT BEEN RETRACTED AND THE LEADING EDGE OF THE DILATOR WAS WEDGED BETWEEN THE DEVICE. THE PHYSICIAN PULLED THE DELIVERY CATHETER AND THE DEVICE SEPARATED FROM THE INTRODUCER SHEATH. AFTER DEPLOYMENT WAS SUCCESSFULLY COMPLETED, THE DELIVERY CATHETER WAS REMOVED AND IT WAS OBSERVED THAT THE LEADING OLIVE TIP WAS NOT ATTACHED. THE LEADING OLIVE TIP WAS OBSERVED ON THE THROUGH-AND-THROUGH WIRE. A BALLOON WAS ADVANCED TO THE DEVICE PORTAL VIA BRACHIAL ACCESS AND THE LEADING OLIVE TIP WAS PUSHED DISTALLY UNTIL IT EXITED THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15583145 ↗