GORE TAG Thoracic Branch Endoprosthesis TSB081706ARecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00733132654390), received between Dec 2, 2022 and Feb 9, 2025 — classified as 3 injuries, 1 malfunction.

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 9, 2025Device Endoleak; Device Endoleak

  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 21341042 ↗
• InjuryMar 26, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  ON (B)(6) 2023, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF A ZONE 2 THORACIC AORTIC ANEURYSM USING GORE® TAG® THORACIC BRANCH ENDOPROSTHESES AT UF HEALTH & HEART VASCULAR HOSPITAL. AN AORTIC COMPONENT (TAC084515) AND A SIDE BRANCH COMPONENT (TSB081706) WERE IMPLANTED. ON (B)(6) 2024, FOLLOW-UP CT IMAGES WERE TAKEN. REVIEW OF THE IMAGES ON (B)(6) 2024, REVEALED A SUSPECTED PORTAL LEAK. ON (B)(6) 2024, A REINTERVENTION WAS PERFORMED. AN 11X59 GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX) WAS USED TO RELINE THE SIDE BRANCH COMPONENT IN THE PORTAL FROM THE LEFT SUBCLAVIAN ARTERY (LSA). AN 8FR. INTRODUCER SHEATH WAS USED FOR DEVICE DELIVERY, THE VBX DEVICE WAS UNDERINFLATED TO 6ATM, A 10X2 PTA BALLOON WAS USED IN THE PORTAL, AND A 14X8 PTA BALLOON WAS USED IN THE LSA. FINAL ANGIOGRAPHY SHOWED NO LEAK. THE PATIENT TOLERATED THE REINTERVENTION.

  Patient problems: Clinical Endoleak

  MAUDE report 18983879 ↗
• InjuryNov 22, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2023, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF A ZONE 2 THORACIC AORTIC DISSECTION USING GORE® TAG® THORACIC BRANCH ENDOPROSTHESES. A GORE® TAG® THORACIC BRANCH SIDE BRANCH COMPONENT WAS IMPLANTED IN THE PATIENT'S LEFT SUBCLAVIAN ARTERY. THERE WERE NO REPORTED ISSUES OBSERVED ON FINAL ANGIO. OR AT THE CLOSE OF THE PROCEDURE. ON (B)(6) 2023, FOLLOW-UP CT IMAGING WAS PERFORMED AND IT WAS OBSERVED THAT THE SIDE BRANCH COMPONENT HAD THROMBOSED. REPORTEDLY, THERE WAS NO PINCHING OBSERVED ON THE SIDE BRANCH COMPONENT, AND NO APPARENT OBSTRUCTION THAT MAY HAVE CAUSED OR CONTRIBUTED TO THE THROMBOSIS. IT WAS FURTHER NOTED THAT THE THROMBOSIS WAS NOT SUSPECTED TO BE RELATED TO THE DEVICE, THAT THE PATIENT HAD BEEN NON-COMPLIANT WITH TAKING POST-OPERATIVE ANTI-COAGULANTS, AND THAT THE PATIENT WAS AN ACTIVE NON-PRESCRIPTION DRUG USER. THE NON-COMPLIANCE WITH POST-OPERATIVE MEDICATIONS/INSTRUCTIONS WAS SUSPECTED TO HAVE CONTRIBUTED TO THE EVENT. IT WAS REPORTED THAT THE PATIENT IS SCHEDULED TO UNDERGO A CAROTID-SUBCLAVIAN BYPASS FOR TREATMENT OF THE THROMBOSED SIDE BRANCH COMPONENT.

  Patient problems: Obstruction/Occlusion

  MAUDE report 18196870 ↗
• MalfunctionDec 2, 2022Malposition of Device; Patient-Device Incompatibility; Difficult to Advance; Physical Resistance/Sticking; Patient-Device Incompatibility

  AS REPORTED, ON NOVEMBER 18TH, 2022, THE PATIENT UNDERWENT TREATMENT IN ZONE 2 FOR A THORACIC AORTIC ANEURYSM AND WAS SUCCESSFULLY IMPLANTED WITH A GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS AORTIC COMPONENT. AS REPORTED, A GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS SIDE BRANCH COMPONENT (TSB, SN: (B)(4) WAS THEN ADVANCED WITH THE BRANCH GOING IN THE LEFT SUBCLAVIAN ARTERY AND RESISTANCE WAS FELT WHEN TRACKING THROUGH THE PORTAL. AS REPORTED, THE PORTAL WAS BALLOONED AND THE GUIDEWIRE WAS SWAPPED FOR A STIFFER WIRE, BUT THE GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS SIDE BRANCH COMPONENT WOULD STILL NOT GO THROUGH THE PORTAL. REPORTEDLY, THE CATHETER FRACTURED AND THE GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS SIDE BRANCH COMPONENT (SN: (B)(4) WAS STUCK IN THE SHEATH. AS REPORTED, A NEW SHEATH WAS OBTAINED FOR USE AND THE THROUGH AND THROUGH WIRE WAS RE-SNARED. AS REPORTED A NEW GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS SIDE BRANCH COMPONENT (SN: (B)(4) WAS OBTAINED FOR USE, PLACED THROUGH A DSF1465, AND OVER THE THRU WIRE. AS REPORTED, THIS DEVICE WAS ALSO NOT TRACKING SUCCESSFULLY AND WAS UNABLE TO BE IMPLANTED. REPORTEDLY THE DSF1465 MADE IT INTO THE PORTAL BUT NOT THRU IT DUE TO LE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15906392 ↗

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