GORE TAG Thoracic Branch Endoprosthesis TAC123715ARecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00733132654215), received between Jun 2, 2023 and Jun 1, 2026 — classified as 2 deaths, 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Positioning Failure” (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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 1, 2026Premature Activation; Improper or Incorrect Procedure or Method

  ON AN UNKNOWN DATE IN THE PAST, THE PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE TO TREAT AN UNKNOWN CONDITION IN THE DESCENDING THORACIC AORTA UTILIZING GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM (CTAG). ON (B)(6) 2026, THE FIELD SALES ASSOCIATE (FSA) WAS MADE AWARE THAT THE PATIENT DEVELOPED A DISSECTION, ORIGINATING PROXIMAL TO THE LEFT SUBCLAVIAN ARTERY (LSA) IN THE THORACIC AORTA, AND THE PHYSICIAN WAS PLANNING TO TREAT IT. ON (B)(6) 2026, THE PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE TO TREAT THE DISSECTION UTILIZING GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS (TBE). IT WAS REPORTED THAT THE TBE AORTIC COMPONENT WAS ADVANCED THROUGH THE SHEATH TO THE PROPER LOCATION OF DEPLOYMENT, AND THEN THE DEVICE TWISTED WITH PROXIMAL WIRE WRAP. THE PHYSICIAN THEN BROUGHT THE DEVICE MOST OF THE WAY BACK INTO THE SHEATH, INSIDE THE PREVIOUSLY IMPLANTED CTAG DEVICE IN THE DESCENDING THORACIC AORTA, THEN PARTIALLY ROTATED THE TBE, AND IT STARTED SELF-DEPLOYING. THE PHYSICIAN WAS ABLE TO REMOVE THE TBE DEVICE AND SHEATH TOGETHER FROM THE PATIENT. THE GORE® DRYSEAL FLEX INTRODUCER SHEATH USED WAS 24 FR, WHICH IS THE CORRECT SIZE FOR THE TBE AORTIC COMPONENT DEVICE US

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25348038 ↗
• 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 24261149 ↗
• DeathJun 28, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  ON (B)(6) 2024, PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE TO TREAT A THORACIC ANEURYSM UTILIZING GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS AND GORE® TRI-LOBE BALLOON CATHETER. UPON ATTEMPTING TO BALLOON THE PROXIMAL END OF TAC123715A DEVICE, THE PATIENT'S AORTA RUPTURED. MEDICAL STAFF ATTEMPTED CPR ON THE PATIENT FOR 10 MINUTES, AND ULTIMATELY PATIENT COULD NOT BE REVIVED AND EXPIRED. IT WAS ALSO REPORTED THERE WERE NO ISSUES DURING THE PROCEDURE, WHILE IMPLANTING THE DEVICES. THE BALLOON DID NOT RUPTURE AND WAS NOT OVER INFLATED. IN ADDITION, NO CALCIFICATION WAS NOTED. PHYSICIAN DOES NOT KNOW WHAT CAUSED THIS ISSUE. PHYSICIAN ALSO REPORTS AS PATIENT WAS OLDER, PATIENT PRESENTED WITH A FRAGILE AORTA. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Great Vessel Perforation

  MAUDE report 19635867 ↗
• DeathDec 8, 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/(B)(6) HAD LANDED SLIGHTLY DISTAL TO THE LSA, LEAVING PLACEMENT OF THE SIDE BRANCH (TSB121506A/(B)(6) 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/(B)(6) WAS PLACED PROXIMALLY TO THE TAC TO EXTEND TRE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18297822 ↗
• InjuryJun 26, 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 MARCH 16, 2023, DURING AN ENDOVASCULAR PROCEDURE (THE PATIENT WAS BEING TREATED FOR A THORACIC DISSECTION) 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. REPORTEDLY, THERE WAS TORTUOUS ANATOMY AND THE REASON FOR EVENT WAS DUE TO TORTUOUS ANATOMY. THE SIDE BRANCH WAS NOT IMPLANTED OR USED DURING THE PROCEDURE. THE PATIENT WAS BEING TREATED FOR A DISSECTION. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Vascular Dissection

  MAUDE report 17200618 ↗
• InjuryJun 2, 2023Positioning Failure; Patient-Device Incompatibility; Difficult to Advance; Positioning Failure; Patient-Device Incompatibility; Difficult to Advance

  ON (B)(6) 2023, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF A ZONE 3 DESCENDING THORACIC AORTIC ANEURYSM AND WAS IMPLANTED WITH GORE® TAG® THORACIC BRANCH ENDOPROSTHESES (TBE) AND GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM (CTAG-AC). THE PATIENT WAS REPORTED TO HAVE A VERY SERPENTINE AND TORTUOUS AORTA; AND DURING ADVANCEMENT OF THE GORE® TAG® AORTIC COMPONENT (TAC123715A) THE PHYSICIAN REPEATEDLY ENCOUNTERED WIRE WRAP OF THE LEADING OLIVE. THE DEVICE WAS WITHDRAWN BACK INTO THE DESCENDING AORTA TO RESOLVE THE WIRE WRAP. MULTIPLE ATTEMPTS WERE MADE TO RE-ADVANCE UP OVER THE ARCH AND AGAIN WIRE WRAP AT THE LEADING OLIVE WAS AN ISSUE. THE PHYSICIAN THEN LOST WIRE ACCESS, AND CHOSE TO DEPLOY THE DEVICE WHERE IT WAS AND THE DEVICE DEPLOYED WITH THE PORTAL POSITIONED TOWARDS THE LESSER CURVE. WIRE WRAP OF THE LEADING OLIVE WAS STILL AN ISSUE AND THE PHYSICIAN WITHDREW THE THROUGH WIRE FROM THE PRE-CANNULATED GATE FROM THE ARM TO RESOLVE THE WIRE WRAP. THE PHYSICIAN THEN ATTEMPTED TO REGAIN ACCESS TO THE PORTAL GATE FROM THE OTHER SIDE TO REGAIN ACCESS BACK UP INTO THE LEFT SUBCLAVIAN ARTERY (LSA) BUT WAS UNSUCCESSFUL. AN ADDITIONAL CTAG-AC WAS THEN ADVAN

  Patient problems: Obstruction/Occlusion

  MAUDE report 17054473 ↗

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