GORE TAG Thoracic Branch Endoprosthesis TE3442ARecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00733132654314), received between Sep 28, 2023 and Feb 4, 2026 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Malposition of Device” (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 4, 2026Obstruction of Flow; Malposition of Device

  ON (B)(6) 2026, THE PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE TO TREAT A PENETRATING AORTIC ULCER (PAU) IN THE THORACIC AORTA UTILIZING GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS (TBE). REPORTEDLY, THE AORTIC COMPONENT AND SIDE BRANCH COMPONENT OF THE TBE WERE IMPLANTED, BUT THE PHYSICIAN LANDED THE AORTIC COMPONENT SHORT OF THE TARGET LESION SEAL ZONE. THE PHYSICIAN THEN IMPLANTED AN AORTIC EXTENDER COMPONENT WHICH MIGRATED FORWARD DURING DEPLOYMENT AND UNINTENTIONALLY COVERED THE LEFT CAROTID ARTERY. THE PHYSICIAN THEN IMPLANTED A GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX) TO OPEN THE CLOSED CAROTID ARTERY AND COMPLETED A SUBCLAVIAN-CAROTID BYPASS; HOWEVER, THE PATIENT STROKED. THE CAUSE OF THE UNINTENDED AORTIC EXTENDER MOVEMENT IS UNKNOWN, AS THE DEVICE WAS REPORTEDLY DEPLOYED PER IFU. DEVICE MIGRATION DISTANCE IS UNKNOWN, HOWEVER IS ESTIMATED TO BE BETWEEN 5-10MM.

  Patient problems: Stroke/CVA

  MAUDE report 24257881 ↗
• MalfunctionAug 4, 2025Difficult or Delayed Activation; Difficult or Delayed Activation

  ON (B)(6) 2025, PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE, UTILIZING GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS (TAC083415A-TBE AORTIC COMPONENT + TE3442A-TBE AORTIC EXTENDER) TO TREAT A THORACIC ANEURYSM. IT WAS REPORTED AFTER DEPLOYMENT OF THE TBE AORTIC COMPONENT, THE PHYSICIAN ELECTED TO SWITCH THE WIRE IN THE LSA FROM AN AMPLATZ WIRE TO A MUCH STIFFER LUNDERQUIST WIRE, PRIOR TO DEPLOYING THE SIDE BRANCH. THIS WIRE EXCHANGE CAUSED THE MAIN TBE AORTIC COMPONENT TO CHANGE ORIENTATION AND TURNED THE PORTAL ANTERIORLY. IT WAS ALSO REPORTED THE PHYSICIAN NEEDED TO EXTEND PROXIMALLY FROM THE TBE AORTIC COMPONENT WITH A TBE THORACIC AORTIC EXTENDER TO GAIN MORE PROXIMAL SEAL. THE TBE AORTIC EXTENDER WAS THEN ADVANCED INTO POSITION ON THE SAME LUNDERQUIST WIRE THAT THE AORTIC COMPONENT HAD BEEN DEPLOYED. UPON DEPLOYMENT, THE AORTIC EXTENDER DID NOT OPEN UP COMPLETELY (AROUND 6MM). IT WAS ALSO REPORTED THE PHYSICIAN WAS ABLE TO WIRE THE AORTIC EXTENDER NEXT TO THE DELIVERY CATHETER AND A BALLOON WAS USED TO EXPAND THE GRAFT ENOUGH TO REMOVE THE DELIVERY CATHETER WITHOUT ANY ISSUE. A MOB37 BALLOON WAS THEN SUCCESSFULLY DELIVERED THRU THE AORTIC EXTENDER AND BALLOONED OPEN AORTIC EXTENDE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22710068 ↗
• InjuryFeb 7, 2024Malposition of Device; Patient-Device Incompatibility; Malposition of Device; Patient-Device Incompatibility

  ON (B)(6) 2023, PATIENT UNDERWENT TREATMENT FOR A ACUTE TYPE B DISSECTION UTILIZING GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS (TBE-TAC083415A). PROCEDURE WAS COMPLETED AND A SMALL LEAK WAS IDENTIFIED. PHYSICIAN DECIDED TO MONITOR THIS LEAK. ON AN UNKNOWN DATE, A CT SCAN WAS PERFORMED WHICH REVEALED A LARGER LEAK, VERY LIKELY A TYPE 1A ENDOLEAK. PHYSICIAN STILL DECIDED TO MONITOR THIS LEAK, WITH NO PLANS FOR REINTERVENTION SURGERY. ON (B)(6) 2023, AN ADDITIONAL CT SCAN WAS PERFORMED. THE TYPE 1A ENDOLEAK SEEMED TO MOSTLY RESOLVE, HOWEVER THERE WAS STILL A SMALL LEAK THAT REMAINED. ON (B)(6) 2023 PATIENT UNDERWENT REINTERVENTION SURGERY DUE TO THIS TYPE 1 ENDOLEAK ((B)(4) WAS OPENED TO CAPTURE THIS TYPE 1 ENDOLEAK REQUIRING REINTERVENTION). ON (B)(6) 2023 DURING REINTERVENTION SURGERY, A GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS (TBE AORTIC EXTENDER ¿ TBE TE3742) WAS UTILIZED TO EXTEND PROXIMALLY. AT THE MOST PROXIMAL EXTENT, THE TE3742 WAS SMALLER THAN THE PATIENT ANATOMY. DURING DEPLOYMENT, THE AORTIC EXTENDER MIGRATED PROXIMALLY (ABOUT 10 MM). THE AORTIC EXTENDER PARTIALLY COVERED THE LEFT COMMON CAROTID ARTERY. SURGICAL BYPASS WAS PERFORMED TO INCLUDE BLOOD FLOW INTO THE CAROTID

  Patient problems: Obstruction/Occlusion

  MAUDE report 18658311 ↗
• InjurySep 28, 2023Positioning Failure; Positioning Failure

  ON (B)(6) 2023, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF A ZONE 2 DISSECTION AND WAS IMPLANTED WITH GORE® TAG® THORACIC BRANCH ENDOPROSTHESES (TBE). THE PHYSICIAN STATES THE GORE® TAG® THORACIC BRANCH AORTIC EXTENDER COMPONENT (AE) INITIALLY DEPLOYED ACCURATELY; HOWEVER FROM THE TIME IT TOOK THE TEAM TO REMOVE THE DELIVERY CATHETER OF THE AE, AND PERFORM A FINAL ANGIOGRAM, THE DEVICE HAD MIGRATED APROXIMALLY, PARTIALLY COVERING THE LEFT CAROTID ARTERY. ONCE MIGRATION WAS NOTED, THE PHYSICIAN ACCESSED THE PATIENT¿S LEFT CAROTID ARTERY TO PLACE A STENT AND WHILE DOING SO, NOTICED THE PATIENT HAD A RETROGRADE TYPE A DISSECTION. THE PHYSICIAN BELIEVES THE RETROGRADE TYPE A DISSECTION WAS CAUSED BY THE PROXIMAL MIGRATION OF THE AORTIC EXTENDER. THE PATIENT¿S RETROGRADE TYPE A DISSECTION WAS TREATED WITH OPEN SURGERY. THE PATIENT TOLERATED THE PROCEDURE. AFTER REVIEWING IMAGES AND SIZING REQUIREMENTS WITH THE PHYSICIAN IT WAS DETERMINED THAT THE LIKELY CAUSE OF THE MIGRATION WAS LACK OF PROXIMAL OVERSIZING OF THE AORTIC EXTENDER. THE PATIENT¿S AORTA MEASURED 34MM AT THE PROXIMAL LANDING ZONE, WHICH IS LARGER THAN THE MAXIMUM VESSEL DIAMETER FOR A 34MM AORTIC EXTENDER.

  Patient problems: Vascular Dissection

  MAUDE report 17840646 ↗

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