GORE TAG Thoracic Branch Endoprosthesis TE3140ARecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00733132654307), received between Feb 23, 2023 and Apr 25, 2025 — classified as 3 injuries.

The most frequently reported specific device problem is “Positioning Problem” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryApr 25, 2025Positioning Problem; Positioning Problem

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2025, THE PATIENT WAS IMPLANTED WITH A GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS AORTIC EXTENDER IN THE ASCENDING AORTA TO COVER THE DISTAL ANASTOMOSIS FROM A PREVIOUS CORONARY ARTERY BYPASS GRAFT OPEN REPAIR. REPORTEDLY THE CORONARY ARTERY BYPASS OPEN REPAIR OCCURRED APPROXIMATELY A MONTH AGO. THE PROXIMAL LUMEN OF THE ARTERY DIAMETER WAS 24-26 MM AND THE DISTAL LUMEN OF THE ARTERY DIAMETER WAS 10 MM. THE DISTAL AREA WAS CAUSING A STRICTURE IN THE ARTERY. IT WAS REPORTED THAT AFTER THE GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS AORTIC EXTENDER WAS DEPLOYED, THERE WAS SOME RESISTANCE IN REMOVING THE DELIVERY CATHETER. SOME FORCE WAS USED TO REMOVE THE DELIVERY CATHETER AND WHILE DOING SO THE GRAFT WAS PULLED DOWN APPROXIMATELY 5 TO 6 MM. THIS CAUSED PARTIAL COVERAGE OF THE INNOMINATE ARTERY. THE PHYSICIAN CHOSE TO USE A BARE METAL STENT IN THIS AREA. THE BARE METAL STENT WAS DEPLOYED IN THE INNOMINATE ARTERY GOING INTO THE RIGHT COMMON CAROTID ARTERY, DUE TO THE INNOMINATE ARTERY BEING SHORT (2 CM). THE PATIENT TOLERATED THE PROCEDURE. IT IS UNKNOWN WHAT CAUSED THE DEVICE TO MOVE AFTER DEPLOYMENT. THE OLIVE MAY HAVE CAUGHT ON THE EDGE OF

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21912669 ↗
• InjuryMay 14, 2024Positioning Problem; Positioning Problem

  THE FOLLOWING WAS REPORTED TO GORE: ON FRIDAY (B)(6) 2024, THE PATIENT HAD A CAROTID TO LEFT SUBCLAVIAN BYPASS TO TREAT A PSEUDOANEURYSM ON THE INNER CURVE OF THE AORTA. ON FRIDAY (B)(6) 2024, THE PATIENT WAS FURTHER TREATED FOR THE PSEUDOANEURYSM WITH GORE® TAG® THORACIC BRANCH ENDOPROSTHESES, WITH THE BRANCH GOING INTO THE LEFT SUBCLAVIAN. AFTER DEPLOYMENT, IT WAS DETERMINED THAT THEY NEEDED TO EXTEND PROXIMALLY WITH AN AORTIC EXTENDER. AFTER DEPLOYING THE EXTENDER, THE ANGIOGRAPHY SHOWED THAT THE INNOMINATE ARTERY WAS COVERED 30-40%. THE PHYSICIAN ADVANCED A CODA BALLOON ON THE DIAGNOSTIC WIRE FROM THE PIGTAIL, WHICH HAD BEEN LOCATED DISTAL OF THE EXTENDER. THE BALLOON WAS USED IN AN ATTEMPT TO DISLODGE THE EXTENDER AND MOVE IT DISTALLY, BUT THIS ATTEMPT FAILED. THE PHYSICIAN THEN ATTEMPTED TO USE A SNARE TO PULL THE EXTENDER CUFF DISTALLY. HOWEVER, WHEN THIS WAS ATTEMPTED, THE EXTENDER MIGRATED QUICKLY PROXIMALLY, LANDING IN THE ASCENDING AORTA. THIS MIGRATION RESOLVED THE PREVIOUS COVERAGE ISSUE; HOWEVER, THE EXTENDER DID NOT HAVE APPOSITION AGAINST THE VESSEL. BECAUSE THE EXTENDER WAS HIGHLY LIKELY TO MIGRATE, A BARE METAL STENT WAS INSERTED TO PIN THE EXTENDER AGAINST THE VE

  Patient problems: Obstruction/Occlusion

  MAUDE report 19310702 ↗
• InjuryFeb 23, 2023Malposition of Device; Malposition of Device

  ON (B)(6) 2023, THE PATIENT WAS TREATED FOR A THORACIC AORTIC ANEURYSM. THE PHYSICIAN IMPLANTED A GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS. THE DEVICE PARTIALLY COVERED THE CAROTID ARTERY. THY PHYSICIAN CUT DOWN AND STENTED THE CAROTID. THE PHYSICIAN IS UNSURE WHY THE CAROTID WAS PARTIALLY COVERED. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16427937 ↗

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