GORE TAG Thoracic Branch Endoprosthesis TSB081006ARecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00733132654369), received between Jun 19, 2023 and Sep 9, 2025 — classified as 6 injuries, 1 malfunction.

The most frequently reported specific device problem is “Blocked Connection” (1 report).

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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 9, 2025Fracture; Fracture

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2025, THE PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE TO TREAT A PENETRATING ATHEROSCLEROTIC ULCER (PAU), UTILIZING GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS (TBE SIDE BRANCH COMPONENT). IT WAS REPORTED THE TBE SIDE BRANCH COMPONENT WAS DEPLOYED AND IMPLANTED WITH NO ISSUES. UPON REMOVING THE TBE SIDE BRANCH COMPONENT, THE OLIVE TIP BROKE OFF FROM THE DELIVERY CATHETER. THE OLIVE TIP WAS SUCCESSFULLY RETRIEVED. NO RESISTANCE WAS NOTED UPON REMOVAL OF DELIVERY CATHETER. THE PHYSICIAN DOES NOT KNOW WHAT CAUSED THIS ISSUE. THE PATIENT TOLERATED THE PROCEDURE. NO FURTHER PATIENT INFORMATION IS AVAILABLE. THE DELIVERY CATHETER WILL BE RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23000313 ↗
• InjuryJul 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING WAS REPORTED: ON (B)(6) 2025, THE PATIENT WAS IMPLANTED WITH GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS (TBE AORTIC COMPONENT AND SIDE BRANCH) TO TREAT A THORACIC DISSECTION. THE PATIENT TOLERATED THE PROCEDURE. IT WAS REPORTED THAT ON (B)(6) 2025, THE PATIENT PRESENTED TO THE EMERGENCY ROOM WITH A WEAK PULSE IN THE LEFT ARM. IMAGES REVEALED THE GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS SIDE BRANCH WAS COMPRESSED. THE PATIENT HAD VERY TORTUOUS ANATOMY IN THE LEFT SUBCLAVIAN ARTERY. ON (B)(6) 2025, THERE WAS A REINTERVENTION. THE PHYSICIAN IMPLANTED AN ADDITIONAL GRAFT TO CORRECT THE COMPRESSED LIMB. THE COMPRESSION WAS RESOLVED, AND THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Vasoconstriction

  MAUDE report 22385632 ↗
• InjuryJun 4, 2025Blocked Connection; Blocked Connection

  ON (B)(6) 2025, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR A ZONE 2 BRANCHED ENDOVASCULAR ANEURYSM REPAIR (BEVAR) AND THE PATIENT WAS IMPLANTED WITH GORE® TAG® THORACIC BRANCH ENDOPROSTHESES. IT WAS REPORTED THAT DURING REMOVAL OF THE 24 FR GORE® DRYSEAL INTRODUCER SHEATH THE RIGHT EXTERNAL ILIAC ARTERY (REIA) WAS RUPTURED. THE PHYSICIAN ADVANCED A BALLOON GOT CONTROL AND IMPLANTED A GORE® VIABAHN EXPANDABLE ENDOPROSTHESIS TO TREAT THE RUPTURE. IT WAS REPORTED THAT THE PATIENT¿S REIA DIAMETER MEASURED APPROXIMATELY 6.8 MM. THE PATIENT DID NOT REQUIRE ANY TRANSFUSION AND BLOOD LOSS WAS REPORTED TO HAVE BEEN MINIMAL (AMOUNT UNKNOWN). THE PATIENT TOLERATED THE PROCEDURE WITH GOOD RESULTS. ON (B)(6) 2025, THE PATIENT UNDERWENT REINTERVENTION FOR A SUSPECTED KINK OF THE GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS (SIDE BRANCH COMPONENT TSB). COMPUTED TOMOGRAPHY ANGIOGRAPHY PERFORMED THIS DATE SHOWED SOME NARROWING OF THE LEFT SUBCLAVIAN ARTERY (LSA), AND THROMBUS BUILDING ON THE TSB. THE PHYSICIAN PERFORMED ADDITIONAL ANGIOPLASTY AT THE AREA OF THE KINK ON THE TSB DEVICE USING AN 8MM BALLOON, AND THEN USING A 9MM BALLOON. THE PHYSICIAN REPORTED GOOD RESULTS AND BELIEVED TO HAVE RES

  Patient problems: Thrombosis/Thrombus

  MAUDE report 22145564 ↗
• InjuryMay 21, 2025Malposition of Device; Malposition of Device

  ON (B)(6) 2025, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR A ZONE 3 THORACIC AORTIC ANEURYSM AND WAS IMPLANTED WITH GORE® TAG® THORACIC BRANCH ENDOPROSTHESES (TAC083415A/(B)(6), AORTIC COMPONENT) AND A GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS (TSB081506A/(B)(6), SIDE BRANCH COMPONENT). RADIAL ACCESS AND A SINGLE SIDED GROIN ACCESS HAD BEEN OBTAINED. IT WAS REPORTED THAT BOTH DEVICES DEPLOYED PROPERLY, WITH ZERO COMPLICATIONS. ON THE FINAL ANGIO RUN, THE LEFT SUBCLAVIAN DISTAL TO THE VERTEBRAL ARTERY LOOKED LIKE IT WAS SPASMING, AND A DISCUSSION REGARDING A POTENTIAL DISSECTION WAS HAD. THE DOCTOR ENDED UP HAVING TO CUT DOWN ON THE ARM BECAUSE THERE WAS NO FLOW. THE PATIENT TOLERATED THE PROCEDURE. LATER THIS SAME NIGHT AROUND 6 PM THE PATIENT WAS REPORTED TO HAVE HAD A STROKE. IT WAS BELIEVED THAT THE ARTERY HAD BEEN DISSECTED DURING THE INITIAL ACCESS FROM THE ARM, AND THEY HAD GOTTEN BACK IN TRUE LUMEN SO THE STENT DEPLOYED FROM BELOW WITHIN THE TRUE LUMEN; AND THE REMAINDER OF THE ARM WAS DISSECTED. THE PATIENT TOLERATED THE PROCEDURE.

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

  MAUDE report 22065590 ↗
• InjuryFeb 11, 2025Complete Blockage; Complete Blockage

  ON (B)(6) 2024, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT IN ZONE 2 OF THE THORACIC AORTA AND WAS IMPLANTED WITH GORE® TAG® THORACIC BRANCH ENDOPROSTHESES. THE PATIENT TOLERATED THE PROCEDURE WITH GOOD RESULTS. ON (B)(6) 2025, THE PHYSICIAN PROVIDED COMPUTED TOMOGRAPHY IMAGING THAT APPEAR TO SHOW AN OCCLUSION OF THE GORE® TAG® THORACIC SIDE BRANCH (SB) COMPONENT. IT IS UNKNOWN IF THE OCCLUSION IF COMPLETE OR PARTIAL. IMAGES HAVE BEEN UPLOADED TO GORE FOR EVALUATION. THERE HAS BEEN NO REINTERVENTION PERFORMED OR SCHEDULED TODATE.

  Patient problems: Obstruction/Occlusion

  MAUDE report 21360853 ↗
• InjuryJan 15, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  THE FSA REPORTED THE FOLLOWING TO GORE: ON (B)(6) 2025, THE PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE TO TREAT AN ANEURYSM UTILIZING THE GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS (TBE) IN ZONE 2. IT WAS REPORTED THAT THE TBE WAS PLACED LANDING AT THE BOVINE ARCH. THE BRANCH COMPONENT WAS AT THE LEFT SUBCLAVIAN. THE TBE MOVED BACK A LITTLE SO A CUFF WAS PLACED. THE CUFF JUMPED FORWARD A LITTLE COVERING THE BOVINE ARCH ABOUT 40%. THERE WAS STILL GOOD FLOW IN THE BOVINE ARCH. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2025, A FOLLOW UP CT WAS PERFORMED AND PHYSICIAN STATED THAT THE POST CT LOOKED GOOD; HOWEVER, THE PATIENT EXPERIENCED AT POSTERIOR STROKE. THE PHYSICIAN ATTRIBUTED THE POSTERIOR STROKE TO ADVANCING THE TERUMO SHEATH THROUGH THE ARM INTO THE LEFT SUBCLAVIAN. HE BELIEVES PLAQUE MAY HAVE BROKEN OFF AT THIS TIME LEADING TO THE POSTERIOR STROKE. IT IS UNKNOWN WHY THE TBE PULLED BACK AND WHY THE CUFF JUMPED FORWARD.

  Patient problems: Stroke/CVA

  MAUDE report 21162032 ↗
• InjuryJun 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2023, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR A TRAUMATIC AORTIC INJURY TO THE LEFT SUBCLAVIAN ARTERY (LSA) DUE TO A FALL ON HER ARM AND SHOULDER A WEEK PREVIOUS. THE PATIENT WAS IMPLANTED WITH GORE® TAG® THORACIC BRANCH ENDOPROSTHESES. IT WAS NOTED THAT THE PATIENT HAD BOVINE ARCH. IT WAS REPORTED THAT THE PROCEDURE WENT SMOOTHLY AND ACCORDING TO PLAN; ALL DELIVERY DEVICES WERE REMOVED INTACT; ALL WIRES, CATHETERS, SHEATHS WERE REMOVED INTACT; VESSEL CLOSURE DEVICES WERE UTILIZED FOR 24F SHEATH ACCESS SITE; WITH MANUAL PRESSURE WAS HELD ON LT BRACHIAL ARM ACCESS SITE. DURING THE TIME PRESSURE WAS BEING HELD AND ANESTHESIA WAS WAKING THE PATIENT UP, THE PATIENT WENT INTO DISTRESS. COMPRESSIONS WERE BEGUN AND A TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) WAS PERFORMED WHEREIN IT WAS DISCOVERED THAT THE PATIENT HAD A TYPE A DISSECTION (WHICH HAD NOT BEEN PRESENT BEFORE THE CASE HAD BEGUN). COMPRESSIONS WERE CONTINUED AND AS THE THORACIC SURGEON WAS GETTING READY TO OPEN THE CHEST TO PUT THE PATIENT ON BYPASS; THE SURGEON ENCOUNTERED DIFFICULTY GETTING THE TROCARS PLACED. COMPRESSIONS CONTINUED AND IT WAS NOTED THAT THE PATIENT¿S STOMACH STARTED DISTENDING INCREDIBLY FAST

  Patient problems: Crushing Injury

  MAUDE report 17153914 ↗