GORE TAG Thoracic Endoprosthesis TGT4020Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00733132613717), received between Feb 24, 2020 and May 22, 2023 — classified as 5 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 reports).

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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryMay 22, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2013, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT AFTER A TOTAL ARCH REPLACEMENT FOR STANFORD TYPE A AORTIC DISSECTION. 2 GORE® TAG® THORACIC ENDOPROSTHESES (TAG) WERE IMPLANTED FROM THE AORTIC ARCH TO THE DESCENDING AORTA. REPORTEDLY THE THORACIC ANEURYSM SIZE AT THE TIME OF INITIAL TREATMENT WAS 58.9 MM. ON AN UNKNOWN DATE IN (B)(6) 2021, FOLLOW-UP CT SCAN SHOWED THAT THE ANEURYSM SIZE HAD INCREASED TO 75.2 MM. FOLLOW-UP OBSERVATION WAS CONTINUED. ON (B)(6) 2023, FOLLOW-UP CT SCAN SHOWED THAT THE ANEURYSM SIZE HAD INCREASED TO 78.2 MM. IT WAS DETERMINED THAT THE ENLARGEMENT WAS DUE TO A PROXIMAL TYPE I ENDOLEAK. ON (B)(6) 2023, A REINTERVENTION WAS PERFORMED AND TWO ADDITIONAL STENT GRAFTS WERE IMPLANTED PROXIMALLY. THE PROXIMAL TYPE I ENDOLEAK WAS RESOLVED.

  Patient problems: Aneurysm expansion; Clinical Endoleak

  MAUDE report 16980107 ↗
• InjuryOct 7, 2020Patient Device Interaction Problem; Patient Device Interaction Problem

  ON (B)(6) 2013, THE PATIENT UNDERWENT TOTAL DEBRANCHING TEVAR OF THE AORTIC ARCH USING GORE® TAG® THORACIC ENDOPROSTHESES. ON AN UNKNOWN DATE, AN UNKNOWN TYPE ENDOLEAK WAS OBSERVED. ON (B)(6) 2020, A RE-INTERVENTION WAS PERFORMED. THE INTRA-OPERATIVE ANGIOGRAPHY IMAGING REVEALED A PROXIMAL TYPE I ENDOLEAK. TWO ADDITIONAL STENT GRAFTS WERE PLACED TO RELINE THE TAG® DEVICES THAT WERE INITIALLY PLACED. NO ENDOLEAK WAS OBSERVED ON THE FINAL ANGIOGRAPHY IMAGING, AND THE PROCEDURE WAS COMPLETED. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Aneurysm

  MAUDE report 10643262 ↗
• InjuryMar 13, 2020Material Integrity Problem; Material Integrity Problem

  ON (B)(6) 2010 THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF A DESCENDING AORTIC ANEURYSM USING GORE® TAG® THORACIC ENDOPROSTHESES. TWO TGT4020 DEVICES WERE USED IN THE PROCEDURE(LOT#8440594 AND LOT#8440595) AND IT IS UNKNOWN WHICH WAS PLACED PROXIMALLY AND WHICH WAS PLACED DISTALLY. ON (B)(6) 2019 CT IMAGING WAS PERFORMED, AND A DISTAL TYPE III ENDOLEAK (FABRIC LEAK - HOLE OR FABRIC DAMAGE IN THE DEVICE MATERIAL) WAS SUSPECTED ON THE PROXIMAL TGT4020 DEVICE. ANEURYSM ENLARGEMENT WAS CONFIRMED (AMOUNT UNKNOWN) IN RELATION TO THE TYPE III ENDOLEAK. THE CAUSE OF THE TYPE III ENDOLEAK IS REPORTEDLY UNKNOWN. A GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM WAS USED TO RELINE THE DEVICE. ON (B)(6) 2020 THE PROXIMAL TGT4020 DEVICE WAS REMOVED FOR REASONS UNRELATED TO THE SUSPECTED TYPE III ENDOLEAK. A HOLE ON THE TGT4020 WAS VISUALLY CONFIRMED. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Aneurysm

  MAUDE report 9831593 ↗
• InjuryMar 13, 2020Material Integrity Problem; Insufficient Device Problem Information; Material Integrity Problem; Insufficient Device Problem Information

  ON (B)(6) 2010 THE PATIENT UNDERWENT TREATMENT OF A DESCENDING AORTIC ANEURYSM USING GORE® TAG® THORACIC ENDOPROSTHESES. TWO TGT4020 DEVICES WERE USED IN THE PROCEDURE(LOT#8440594 AND LOT#8440595) AND IT IS UNKNOWN WHICH WAS PLACED PROXIMALLY AND WHICH WAS PLACED DISTALLY. ON (B)(6) 2019, DURING AN ANEURYSMORRHAPHY TO TREAT ENLARGEMENT OF THE DESCENDING AORTIC ANEURYSM, A HOLE WAS CONFIRMED ON THE DISTAL TGT4020 DEVICE. AMOUNT OF ANEURYSM ENLARGEMENT IS REPORTEDLY UNAVAILABLE. THE SUSPECTED CAUSE OF THE ANEURYSM ENLARGEMENT WAS A TYPE III ENDOLEAK DUE TO THE HOLE IN THE DEVICE MATERIAL. THE CAUSE OF THE TYPE III ENDOLEAK IS REPORTEDLY UNKNOWN. A GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM TGM454520 WAS USED TO RELINE THE DISTAL TGT4020, AND SUTURING OF THE HOLE WAS PERFORMED. IT WAS REPORTED THAT THE PATIENT DEVELOPED AN INFECTION AFTER COMPLETION OF THE PROCEDURE. THE CAUSE OF THE INFECTION IS REPORTEDLY UNKNOWN. THE INFECTION WAS MONITORED WITH MEDICATION (MEDICATION TYPE UNAVAILABLE). ON (B)(6) 2019 AN ADDITIONAL GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM TGM454520 WAS USED TO RELINE THE PROXIMAL TGT4020 DEVICE. THE PATIENT'

  Patient problems: Aneurysm; Unspecified Infection

  MAUDE report 9831513 ↗
• InjuryFeb 24, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON UNKNOWN DATE IN (B)(6) 2013, THIS PATIENT UNDERWENT AN ENDOVASCULAR TREATMENT FOR AN AORTIC DISSECTION USING A GORE® TAG® THORACIC ENDOPROSTHESIS. AT THE FOLLOW UP ON UNKNOWN DATE, AORTIC ENLARGEMENT OF THE DISTAL LANDING ZONE WAS CONFIRMED. SINCE THERE WAS NO ENDOLEAK DETECTED, THE PATIENT WAS MONITORED. THEREAFTER, THE DIAMETER OF THE DESCENDING AORTA ENLARGED TO 60 MM OR GREATER. ON (B)(6) 2020, THE PATIENT UNDERWENT AN ADDITIONAL PROCEDURE WHEREBY A CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESIS WAS IMPLANTED DISTALLY OF PREVIOUSLY IMPLANTED GORE® TAG® THORACIC ENDOPROSTHESIS. THE CAUSE OF AORTIC ENLARGEMENT WAS UNKNOWN.

  Patient problems: Aneurysm

  MAUDE report 9744869 ↗

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