GORE TAG Thoracic Endoprosthesis TGT3715Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00733132613670), received between Jul 11, 2018 and Jun 30, 2021 — classified as 6 injuries.

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

• InjuryJun 30, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2012, THIS PATIENT ENDOVASCULAR TREATMENT USING GORE® TAG® THORACIC STENT GRAFT FOR A CHRONIC TYPE B AORTIC DISSECTION. ON AN UNKNOWN DATE, A POSSIBLE PROXIMAL TYPE I ENDOLEAK WAS OBSERVED. ON (B)(6) 2021, A REINTERVENTION WAS PERFORMED. ONE DEBRANCH BYPASS, A LEFT COMMON CAROTID ARTERY - LEFT SUBCLAVIAN ARTERY BYPASS, PROCEDURE WAS PERFORMED. A CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESIS WAS IMPLANTED PROXIMALLY TO COVER THE LEFT SUBCLAVIAN ARTERY. THE LEFT SUBCLAVIAN ARTERY WAS EMBOLIZED BY PLUG (AVP2 14MM). COMPUTED TOMOGRAPHY ANGIOGRAPHY VERIFIED THE ENDOLEAK WAS RESOLVED. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Aneurysm

  MAUDE report 12093821 ↗
• InjuryAug 21, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2011, THE PATIENT UNDERWENT ENDOVASCULAR REPAIR OF A THORACIC AORTIC ANEURYSM USING A GORE® TAG® THORACIC ENDOPROSTHESIS. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2011, THE MAXIMUM DIAMETER OF THE ANEURYSM WAS 50 MM. ON (B)(6) 2011, THE MAXIMUM DIAMETER OF THE ANEURYSM WAS 50 MM. ON (B)(6) 2012, THE MAXIMUM DIAMETER OF THE ANEURYSM WAS 48 MM. ON (B)(6) 2013, THE MAXIMUM DIAMETER OF THE ANEURYSM WAS 43 MM. ON (B)(6) 2014, THE MAXIMUM DIAMETER OF THE ANEURYSM WAS 48 MM. ON (B)(6) 2015, THE MAXIMUM DIAMETER OF THE ANEURYSM WAS 45 MM. ON (B)(6) 2016, THE MAXIMUM DIAMETER OF THE ANEURYSM WAS 45 MM. ON (B)(6) 2019, AN IMPENDING RUPTURE WAS OBSERVED DUE TO A TYPE 1A AND 1B ENDOLEAK. TWO CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESES WERE IMPLANTED TO EXTEND BOTH PROXIMALLY AND DISTALLY OF THE ORIGINAL IMPLANTED GORE® TAG® THORACIC ENDOPROSTHESIS. IMAGING IDENTIFIED THAT THE TYPE 1B ENDOLEAK REMAINED. BALLOONING WAS THEN PERFORMED TO REPAIR THE TYPE 1B ENDOLEAK. FINAL IMAGING SHOWED THE ENDOLEAK REMAINED SLIGHTLY, BUT AT THIS TIME THE PHYSICIAN DECIDED TO MONITOR IT. THE PATIENT REPORTEDLY TOLERATED THE PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8916455 ↗
• InjuryMay 10, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  ON AN UNKNOWN DATE, A FOLLOW UP IMAGING SHOWED A SUSPECTED PROXIMAL TYPE I ENDOLEAK. ADDITIONALLY, THE ANEURYSM ENLARGEMENT WAS OBSERVED (AMOUNT UNKNOWN).

  Patient problems: Aneurysm; No Code Available

  MAUDE report 8602161 ↗
• InjuryFeb 20, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2011, THE PATIENT WAS IMPLANTED WITH A GORE® TAG® THORACIC ENDOPROSTHESIS TO TREAT A THORACIC ANEURYSM. ON (B)(6) 2015, DURING THE TREATMENT OF AN ABDOMINAL AND RIGHT COMMON ILIAC ARTERY ANEURYSMS JUST BEFORE THE GORE® EXCLUDER® AAA ENDOPROSTHESES WERE IMPLANTED, A TYPE II ENDOLEAK FROM THE DISTAL PORTION OF THE THORACIC AORTA WAS IDENTIFIED. THE PHYSICIAN CONFIRMED THAT THE ORIGIN OF THE TYPE II ENDOLEAK WAS AT THE THORACIC AORTIC ANEURYSM AND THERE WAS NO ISSUE WITH A GORE® EXCLUDER® AAA ENDOPROSTHESIS. ON (B)(6) 2019, THE PATIENT UNDERWENT IR EMBOLIZATION WITH N-BCA GLUE AND 1:3 MIXTURE OF ETHIODOL. NO FURTHER ADVERSE EVENTS HAVE BEEN REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8355934 ↗
• InjuryNov 19, 2018Patient-Device Incompatibility; Patient-Device Incompatibility

  ON (B)(6) 2012, THE PATIENT UNDERWENT ENDOVASCULAR REPAIR OF A CHRONIC TYPE-B THORACIC AORTIC DISSECTION USING A GORE® TAG® THORACIC ENDOPROSTHESIS (TGT3715/(B)(4)). THE PATIENT TOLERATED THE PROCEDURE. LATER IN A FOLLOW-UP STUDY, IT WAS REVEALED THAT A NEW ENTRY TEAR HAD BEEN CREATED AROUND THE DISTAL END OF THE EXISTING ENDOPROSTHESIS (DISTAL STENT-INDUCED NEW ENTRY, D-SINE). ON (B)(6) 2018, A REINTERVENTION WAS PERFORMED WHEREBY TWO CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESES WERE IMPLANTED TO EXCLUDE THE NEW ENTRY TEAR. THE PATIENT TOLERATED THE REINTERVENTION PROCEDURE.

  Patient problems: Aortic Dissection

  MAUDE report 8087601 ↗
• InjuryJul 11, 2018Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem; Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2011, THE PATIENT UNDERWENT TREATMENT OF A THORACIC AORTIC ANEURYSM WITH A GORE® TAG® THORACIC ENDOPROSTHESIS. ACCORDING TO THE REPORT, THE TAG DEVICE WAS POSITIONED AND IMPLANTED DISTAL TO THE OSTIUM OF THE LEFT COMMON CAROTID ARTERY (LCCA). INTRA-PROCEDURAL ANGIOGRAPHY REPORTEDLY SHOWED A PROXIMAL TYPE I ENDOLEAK. AN ADDITIONAL TAG DEVICE WAS IMPLANTED FOR PROXIMAL EXTENSION. FINAL ANGIOGRAPHY, SHOWED EXCLUSION OF THE ANEURYSM, AND NO EVIDENCE OF ENDOLEAK. ACCORDING TO THE REPORT, THE PATIENT TOLERATED THE PROCEDURE. IT WAS REPORTED, ROUTINE FOLLOW-UP COMPUTED TOMOGRAPHY (CT) SCANS WERE PERFORMED UNTIL 2016 WITH NO ADVERSE EVENTS BEING REPORTED. AFTER 2016, THE PATIENT REPORTEDLY WAS LOST TO FOLLOW-UP. ON AN UNKNOWN DATE IN 2018, THE PATIENT AGAIN SOUGHT TREATMENT AND A COMPUTED TOMOGRAPHY SCAN WAS PERFORMED. IMAGING IDENTIFIED EVIDENCE OF AN AORTIC ARCH DISSECTION PROXIMAL TO THE PREVIOUSLY TREATED SEGMENT. ACCORDING TO THE REPORT, THE ENTRY TEAR ORIGINATED FROM THE PROXIMAL EDGE OF THE MOST PROXIMAL TAG DEVICE. IT WAS REPORTED, THE CAUSE OF THE DISSECTION IS UNKNOWN, HOWEVER, THE PHYSICIAN STATED THE PATIENT¿S FRAGILE AORTA HAD WEAKEN OVER TIME DUE TO DISEASE PROGRESS

  Patient problems: Vascular Dissection

  MAUDE report 7678224 ↗

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-1236-06 · Apr 28, 2006 · Terminated
  GORE TAG THORACIC ENDOPROSTHESIS System, Endovascular Graft, Aortic Aneurysm Treatment, Catalogue Number TG3410, 34mm x 10cm
• Z-1237-06 · Apr 28, 2006 · Terminated
  GORE TAG THORACIC ENDOPROSTHESIS System, Endovascular Graft, Aortic Aneurysm Treatment, Catalogue Number TG3415, 34mm x 15cm