GORE TAG Thoracic Endoprosthesis TGT4520Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00733132613748), received between Apr 18, 2019 and Apr 18, 2019 — classified as 1 injury.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).

6 other recalls cover devices cleared under the same FDA submission (P040043); 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryApr 18, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  ON (B)(6) 2013, THE PATIENT UNDERWENT TREATMENT OF A THORACIC AORTIC ANEURYSM LOCATED IN THE AORTIC ARCH USING A GORE TAG® THORACIC ENDOPROSTHESIS (TGT4520/10762704). DURING THE SAME PROCEDURE, THE THORACIC ARCH BRANCH VESSELS WERE BYPASSED AND A STENT GRAFT WAS IMPLANTED INTO ONE OF THE BRANCH VESSELS (¿CHIMNEY TECHNIQUE¿). IN (B)(6) 2018, A FOLLOW-UP COMPUTED TOMOGRAPHY SCAN SHOWED THERE WAS NO ENDOLEAK OR ANEURYSM ENLARGEMENT. IT WAS REPORTED THAT ON (B)(6) 2019, THE THORACIC AORTIC ANEURYSM WAS RUPTURED. THE PATIENT WAS TRANSFERRED TO THE HOSPITAL AND UNDERWENT AN EMERGENT RE-INTERVENTION IN ORDER TO TREAT THE RUPTURE. DURING THE RE-INTERVENTION, AN INTRA-OPERATIVE ANGIOGRAPHY SHOWED A SUSPECTED TYPE III ENDOLEAK. THE PHYSICIAN THOUGHT THAT IT WAS A FABRIC TYPE III ENDOLEAK. A CONFORMABLE GORE TAG® THORACIC ENDOPROSTHESIS (TGU454520J) WAS IMPLANTED TO TREAT THE ENDOLEAK. THE ENDOLEAK WAS RESOLVED. THE PATIENT TOLERATED THE PROCEDURE. THE PHYSICIAN REPORTED THAT THE ENDOLEAK WAS NOT ORIGINATING FROM THE CHIMNEY DEVICE IN THE BRANCH VESSEL. A FRICTION BETWEEN THE FABRIC AND THE STENT MIGHT HAVE CONTRIBUTED TO THE FABRIC TYPE III ENDOLEAK.

  Patient problems: Aneurysm

  MAUDE report 8529350 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P040043. One submission often covers many models, so check the product and lot details in each record.

• Z-0290-2021 · Sep 9, 2020 · Open, Classified
  GORE TAG CONFORMABLE Thoracic Stent Graft with ACTIVE CONTROL System
• Z-0291-2021 · Sep 9, 2020 · Open, Classified
  GORE TAG Conformable Thoracic Stent Graft with ACTIVE CONTROL System
• Z-2052-2020 · Dec 17, 2019 · Terminated
  Conformable Thoracic Stent Graft, Rx only, Sterile EO - Product Usage: This device is intended for endovascular repair of lesions of the descending thoracic aorta.
• Z-0048-2018 · Sep 25, 2017 · Terminated
  GORE TAG, THORACIC ENDOPROSTHESIS, CONFORMABLE. The GORE TAG Thoracic Endoprosthesis is intended for endovascular repair of all lesions of the descending thoracic aorta.
• Z-1237-06 · Apr 28, 2006 · Terminated
  GORE TAG THORACIC ENDOPROSTHESIS System, Endovascular Graft, Aortic Aneurysm Treatment, Catalogue Number TG3415, 34mm x 15cm
• Z-1236-06 · Apr 28, 2006 · Terminated
  GORE TAG THORACIC ENDOPROSTHESIS System, Endovascular Graft, Aortic Aneurysm Treatment, Catalogue Number TG3410, 34mm x 10cm