GORE TAG Thoracic Branch Endoprosthesis TSB081506ARecalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00733132654383), received between Mar 2, 2023 and Sep 30, 2026 — classified as 1 death, 10 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Break” (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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjurySep 30, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50953838 ↗
• InjurySep 10, 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) 2025, PATIENT UNDERWENT A THORACIC ENDOVASCULAR AORTIC REPAIR (TEVAR) TO TREAT A DISSECTION UTILIZING A GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS (AORTIC COMPONENT, SIDE BRANCH AND AORTIC EXTENDER). PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2025, PATIENT UNDERWENT AN ENDOVASCULAR REINTERVENTION PROCEDURE ON A PRIOR TEVAR TO TREAT AN ENDOLEAK AND DISSECTION UTILIZING A GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM (CTAGAC). REPORTEDLY, THERE WAS A TYPE 1A ENDOLEAK FROM THE LEFT SUBCLAVIAN ARTERY WITH THE SIDE BRANCH AND A DISTAL EXTENSION OF THE TYPE B DISSECTION FROM THE AORTIC COMPONENT. THE ENDOLEAK IS POSSIBLY DUE TO A FENESTRATION THAT WAS NOT SEALED PERFECTLY ON THE PROXIMAL SIDE DURING THE ORIGINAL PROCEDURE AND THE DISTAL SIDE WHERE THE DISSECTION MIGHT NOT HAVE BEEN FULLY COVERED. PHYSICIAN IS UNSURE OF THE CAUSE, IF ITS A NEW FENESTRATION OR SIMPLY DID NOT COVER IT ENOUGH DURING THE INITIAL PROCEDURE AS THERE IS FALSE LUMEN PROXIMALLY (ANEURYSM SIZE UNKNOWN) AND TYPE B DISSECTION DISTALLY, WHICH PHYSICIAN FIXED BY ADDING 10-15 TERUMO COILS PROXIMALLY IN THE FALSE LUMEN, JUST OUTSIDE THE LEFT SUBCLAVIAN

  Patient problems: Aneurysm expansion; Clinical Endoleak

  MAUDE report 23015338 ↗
• InjuryJun 26, 2025Obstruction of Flow; Obstruction of Flow

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2025, THE PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE TO TREAT A DISSECTION UTILIZING GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS (AORTIC COMPONENT AND SIDE BRANCH) AND A GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM. REPORTEDLY, THERE WAS TORTUOSITY IN THE LEFT SUBCLAVIAN ARTERY (LSA) THAT APPEARED TO BE SIGNIFICANT; HOWEVER, THE PROCEDURE WENT WELL WITH DEPLOYMENT AND PATIENT WAS DOING FINE. ON MAY 29, 2025, IT WAS REPORTED BY PHYSICIAN TO FIELD SALES ASSOCIATE THAT THE LEFT SUBCLAVIAN ARTERY SIDE BRANCH IS THROMBOSING POST PROCEDURE SCAN FOLLOW UP (DATE UNKNOWN). PATIENT IS CURRENTLY FEELING LEFT ARM PAIN AND PHYSICIAN PLANS TO PERFORM A CAROTID SUBCLAVIAN ARTERY BYPASS. ON JUNE 05, 2025, ADDITIONAL INFORMATION PROVIDED BY PHYSICIAN THAT PATIENT HAS A THORACIC OUTLET SYNDROME THAT LED TO THE THROMBOSIS OF THE SIDE BRANCH. THERE IS NO BLOOD FLOW ISSUES AS OF NOW WITH THROMBOSED GRAFT. CURRENTLY, PATIENT'S SYMPTOMS AREN¿T AS BAD SO A REINTERVENTION MAY NOT BE DONE DUE TO THORACIC OUTLET SYNDROME.

  Patient problems: Limb Pain; Obstruction/Occlusion

  MAUDE report 22342121 ↗
• MalfunctionFeb 22, 2025Break; Positioning Failure; Difficult to Insert; Malposition of Device; Break; Positioning Failure; Difficult to Insert; Malposition of Device

  ON (B)(6) 2025, A PATIENT WAS TREATED FOR A ZONE 2 AORTIC DISSECTION USING A GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS (TBE). AFTER DEPLOYING THE AORTIC COMPONENT, THE PHYSICIAN ADVANCED THE SIDE BRANCH DEVICE. AFTER CANNULATING THE PORTAL, THE PHYSICIAN TRIED TO ADVANCE THE SIDE BRANCH INTO THE LEFT SUBCLAVIAN BUT FELT RESISTANCE. WHEN THE PHYSICIAN APPLIED FORWARD PRESSURE TO THE DEVICE, THE SIDE BRANCH DEVICE SLIPPED FORWARD COMPLETELY INTO THE LSA AND OUT OF THE PORTAL. THE PHYSICIAN WAS UNABLE TO RETRACT THE SIDE BRANCH INTO THE LSA. WHILE MANIPULATING THE DEVICE, THE SIDE BRANCH BEGAN DEPLOYING DISTAL TO PROXIMAL WITHOUT THE DEPLOYMENT WIRE BEING PULLED, COMPLETELY OUTSIDE THE PORTAL. THE PHYSICIAN FINISHED DEPLOYMENT OF THE SIDE BRANCH, AND RETRACTED THE DELIVERY CATHETER. AT THIS POINT, THE PHYSICIAN NOTICED THAT THE LEADING OLIVE WAS SEPARATED FROM THE CATHETER, BUT REMAINED ATTACHED TO THE GUIDE WIRE. THE PHYSICIAN THEN USED THE 5FR SHEATH FROM THE PATIENT'S ARM TO PUSH THE LEADING OLIVE DOWN TO THE FEMORAL ACCESS POINT WHERE IT COULD BE RECEIVED. AN ADDITIONAL SIDE BRANCH DEVICE WAS ADVANCED, AND USED TO BRIDGE BETWEEN THE DEPLOYED SIDE BRANCH AND THE PORTAL. THE PATIENT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21440801 ↗
• InjuryOct 6, 2024Device Endoleak; Device Endoleak

  ON (B)(6) 2023, PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE TO TREAT A ZONE-2 ANEURYSM UTILIZING GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS. ON (B)(6) 2024, PHYSICIAN SENT OVER A CT SCAN TO THE FSA, WHICH SHOWED AN ENDOLEAK. THE CT SCAN WAS DATED ON (B)(6) 2024. ON (B)(6) 2024, DURING A FOLLOW-UP VISIT, A TYPE III ENDOLEAK NEAR THE PORTAL AND ANEURYSM ENLARGEMENT (UNKNOWN AMOUNT) WAS SEEN ON CT IMAGING. PHYSICIAN RECOMMENDS REINTERVENTION SURGERY TO TREAT THIS ENDOLEAK. ON (B)(6) 2024, A REINTERVENTION SURGERY WAS PERFORMED. PHYSICIAN BALLOONED THE PORTAL. AN ANGIOGRAM WAS PERFORMED, AND NO ENDOLEAK WAS OBSERVED. PATIENT TOLERATED THE PROCEDURE. THE CAUSE OF THE ENDOLEAK REMAINS UNKNOWN.

  Patient problems: Clinical Endoleak

  MAUDE report 20380370 ↗
• InjuryMay 2, 2024Device Stenosis; Device Stenosis

  ON (B)(6) 2023, PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE TO TREAT A PENETRATING AORTIC ULCER UTILIZING GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS. ON (B)(6) 2024, THROMBOSIS WAS OBSERVED ON THE THORACIC SIDE BRANCH (TSB081506A) VIA CT SCAN. PHYSICIAN PERFORMED A CAROTID SUBCLAVIAN BYPASS TO TREAT THIS THROMBOSIS. DATE OF TREATMENT REMAINS UNKNOWN. PHYSICIAN POSSIBLY ATTRIBUTES THIS THROMBOSIS TO A NARROWED STENT AND POTENTIAL HYPOTENSION. FSA HAS NO FURTHER INFORMATION ON THIS CASE AS HE WAS NOT PRESENT AT INITIAL PROCEDURE.

  Patient problems: Obstruction/Occlusion

  MAUDE report 19230962 ↗
• InjuryMar 8, 2024Obstruction of Flow; Obstruction of Flow

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2024, THE PATIENT UNDERWENT A THORACIC ENDOVASCULAR AORTIC REPAIR (TEVAR) PROCEDURE TO TREAT A TYPE B DISSECTION AND INTRAMURAL HEMATOMA UTILIZING A GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS (SIDE BRANCH AND AORTIC COMPONENT) IN ZONE 2. IMAGING FOR THIS CASE WAS REQUESTED BUT NOT AVAILABLE. REPORTEDLY, DURING THE PROCEDURE, THE SIDE BRANCH WAS DEPLOYED TOO HIGH AND ENDED UP FULLY COVERING THE LEFT VERTEBRAL ARTERY. THE DEVICE WAS DEPLOYED IN PARALLAX THEREFORE MAKING IT DIFFICULT TO ENSURE ALIGNMENT WITH THE TBE AC AND SB COMPONENTS AS WELL AS THE LOCATION OF THE LEFT VERTEBRAL ARTERY. PHYSICIAN TRIED TO PULL IT DOWN ENDOVASCULARLY WITH AN 8MM BALLOON BUT IT DID NOT WORK. THEY DECIDED TO OPEN UP THE PATIENT'S CHEST AS THEY ASSUMED THERE WAS RETROGRADE TYPE A DISSECTION (RTAD) AS A RESULT OF TRYING TO PULL THE DEVICE DOWN WITH THE BALLOON. ONCE THE PATIENT WAS OPENED UP, THE PHYSICIAN WAS ABLE TO TUG THE GRAFT DOWN INTRAOPERATIVELY AND PROVIDE FLOW TO THE LEFT VERTEBRAL ARTERY AGAIN. THERE WAS NO RETROGRADE TYPE A DISSECTION, NO REMAINING BLOOD FLOW ISSUES, AND THE PATIENT TOLERATED THE PROCEDURE. 2200-E:-VESSEL COVERAGE - OTHER/UNKNOWN

  Patient problems: Obstruction/Occlusion

  MAUDE report 18870799 ↗
• MalfunctionJan 29, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  FSA REPORTED "SIDE BRANCH WAS BEING PUSHED THROUGH PORTAL OF THORACIC SIDE BRANCH DEVICE. PHYSICIAN HAD DIFFICULTY IN ADVANCING THROUGH PORTAL AND CONTINUOUSLY TWISTED DELIVERY CATHETER. DEVICE WAS EVENTUALLY DEPLOYED IN APPROPRIATE LOCATION OF LSA. UPON DEPLOYMENT AND AFTER DELIVERY CATHETER WAS REMOVED, IT WAS NOTED THAT THE NOSE CONE AND INNER CANULA WAS LEFT BEHIND ON THE WIRE. ATTEMPT WAS MADE AT SNARING. ULTIMATELY THE NOSE CONE AND CANULA WERE REMOVED VIA AXILLARY CUTDOWN."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18595993 ↗
• InjuryOct 9, 2023Fluid/Blood Leak; Fluid/Blood Leak

  ON (B)(6) 2023, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF A ZONE 2 DISSECTION AND WAS IMPLANTED WITH GORE® TAG® THORACIC BRANCH AORTIC COMPONENTS (TBE). THE PATIENT TOLERATED THE PROCEDURE WITH GOOD RESULTS AND GOOD SEAL. ON (B)(6) 2023, THE PHYSICIAN REPORTED THE PATIENT HAS A PROXIMAL TYPE I EDOLEAK ASSOCIATED WITH THE TSB081506A/26311136. THE PHYSICIAN PLANS TO REINTERVENE ON WEDNESDAY, (B)(6) 2023. THE PHYSICIAN BELIEVES THEY MAY HAVE NOT ACHIEVED ENOUGH PURCHASE UP INTO THE LEFT SUBCLAVIAN ARTERY WITH THE GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS SIDE BRANCH COMPONENT (TSB). WHEN INITIALLY DEPLOYED DUE THE DISSECTION, THE PORTAL HAD NOT BEEN LANDED EXACTLY AT THE LSA; SO WHEN DEPLOYED IT THERE WERE SOME DISTANCE FROM THE PORTAL TO GET TO THE LEFT SUBCLAVIAN. FINAL RUN HAD SHOWN GOOD SEAL INITIALLY HOWEVER THE PHYSICIAN BELIEVES THE TSB HAS SLIPPED OUT OF THE PORTAL PORTION OF THE BRANCH DEVICE AND THERE A TYPE I ENDOLEAK AND CONTRAST CAN BE SEEN LEAKING FROM THE TOP OF THE LEFT SUBCLAVIAN BRANCH INTO BACK INTO THE DISSECTION. ON (B)(6) 2023, THE PATIENT UNDERWENT REINTEVENTION AND THE ENDOLEAK WAS TREATED BY EXTENDING THE LSA BRANCH DEVICE, USING A GORE® VIABAHN® VBX BA

  Patient problems: Vascular Dissection

  MAUDE report 17898846 ↗
• DeathAug 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6), 2023, THIS PATIENT UNDERWENT PART ONE OF A PLANNED STAGED ENDOVASCULAR TREATMENT FOR A THORACOABDOMINAL AORTIC ARCH ANEURYSM. THE PATIENT WAS IMPLANTED WITH GORE® TAG® THORACIC BRANCH ENDOPROSTHESES (TSB081506A/(B)(6) AND TAC083415A/(B)(6)) AND A GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM (TGM343420/(B)(6)) USING A GORE® DRYSEAL SHEATH. POST DEPLOYMENT OF THE DEVICES THE PATIENT EXPERIENCED A SHOWER OF EMBOLI DUE TO PLAQUE DISLODGEMENT. EMBOLI AND PLAQUE WERE REPORTED TO TRAVEL DISTALLY AND DEPOSIT WITHIN THE PATIENT¿S ARMS, VISCERAL VESSELS, AND THE DISTAL AORTA. THE PHYSICIAN PERFORMED CUTDOWNS ON THE PATIENT¿S ARMS AND CLEARED AND SUCTIONED OUT CLOTS AND EMBOLI FROM THE VISCERAL VESSELS AND DISTAL AORTA. A RENAL ARTERY WAS STENTED. THE PATIENT TOLERATED THE PROCEDURE. THE CAUSE OF THE EMBOLI SHOWER WAS REPORTED TO BE DUE TO TORTUOSITY AND A SUBSTANTIAL AMOUNT OF PLAQUE BUILD UP IN THE PATIENT¿S MID DESCENDING THORACIC AORTA. IT WAS REPORTED THAT A GREAT AMOUNT OF MANIPULATION OF THE SHEATH AND DELIVERY CATHETER HAD BEEN REQUIRED TO ADVANCE THE (TAC083415A/(B)(6)) PAST THIS AREA TO GET IT TO PROPERLY LINE UP FOR DEPLOYMENT. IT WAS ESTIMATED

  Patient problems: Aneurysm

  MAUDE report 17482742 ↗
• InjuryMay 19, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  ON (B)(6) 2023, THE PHYSICIAN IMPLANTED A GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2023, THE PHYSICIAN SUSPECTED A TYPE IB ENDOLEAK FROM THE GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS SIDE BRANCH, AND IMPLANTED A GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS TO TREAT THE ENDOLEAK. THE ENDOLEAK PERSISTED, AND THE PHYSICIAN ENDED THE PROCEDURE. THE EVENT IS ONGOING.

  Patient problems: Clinical Endoleak

  MAUDE report 16962659 ↗
• InjuryApr 26, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2023, THE PATIENT UNDERWENT AN ENDOVASCULAR ZONE 2-LCC PROCEDURE TO TREAT AN ANEURYSM UTILIZING GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS. THE PATIENT TOLERATED THE PROCEDURE. DURING A FOLLOW UP (DATE UNKNOWN), REPORTEDLY A CT SCAN WAS DONE, AND ON (B)(6) 2023, THE FSA WAS NOTIFIED THAT THE SUBCLAVIAN COMPONENT OF GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS (SIDE BRANCH) WENT DOWN AS IT OCCLUDED. THERE WAS NO MIGRATION AND THE REASON FOR THE OCCLUSION IS UNKNOWN AND THERE IS NO CONTINUOUS BLOOD FLOW. REPORTEDLY, THE ORIGINAL IMPLANT PROCEDURE AND ANATOMY WERE GOOD AND NO ISSUES AROSE WHEN THE FINAL RUN/SCAN WAS DONE AT THE END OF THE PROCEDURE. A NEW CT SCAN HAS NOT BEEN PRESENTED. THE HOSPITAL DOES NOT PLAN TO RE-INTERVENE AND THE OCCLUSION WILL BE LEFT ALONE AS THE PATIENT WILL SURVIVE WITH THE OCCLUDED LSA. IMAGING EVALUATION SUMMARY: THE IMAGING EVALUATION PERFORMED BY A CLINICAL IMAGING SPECIALIST SHOWED THE FOLLOWING: PRE-IMPLANT CTA AND ONE 5 SECOND MOVIE AVAILABLE FOR ANALYSIS. PRE-IMPLANT CTA SHOWS DIAMETERS IN THE PROXIMAL 3 CM OF THE LSA RANGE FROM 11.3 MM ¿ 14.0 MM. DIAMETER AT THE 1ST BRANCH IN THE LSA MEASURES ~ 11.6 AT ~ 37

  Patient problems: Obstruction/Occlusion

  MAUDE report 16818133 ↗
• InjuryMar 2, 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) 2022, THE PATIENT WAS IMPLANTED WITH GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS (TBE) TO TREAT A ZONE 2 TYPE B THORACIC DISSECTION WITH MALPERFUSION. IT WAS REPORTED THAT ON (B)(6) 2023, THE PATIENT PRESENTED WITH A RETROGRADE TYPE A DISSECTION. ON (B)(6) 2023, THE PHYSICIAN REINTERVENED AND PERFORMED A COMPLETE AORTIC ARCH REPLACEMENT BY CT SURGERY. THE PATIENT TOLERATED THE PROCEDURE. THE RETROGRADE TYPE A DISSECTION DOES ORIGINATE IMMEDIATELY ADJACENT TO THE GORE DEVICE SURGEONS ARE BLAMING THIS SEQUELAE ON THE PATIENTS METH USE. PATIENTS ADMITTED METH USE AND TESTED POSITIVE THE DAY OF SURGERY.

  Patient problems: Vascular Dissection

  MAUDE report 16473301 ↗