GORE TAG Conformable Thoracic Endoprosthesis TGU404015Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00733132618163), received between Sep 13, 2018 and Nov 15, 2022 — classified as 6 injuries, 1 malfunction.

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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryNov 15, 2022Activation, Positioning or Separation Problem; Insufficient Device Problem Information; Activation, Positioning or Separation Problem; Insufficient Device Problem Information

  ON (B)(6) 2018, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF A THORACIC AORTIC DISSECTION WITH CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESES (TGU404015/15928245)-MOST ADJACENT TO THE TBE AORTIC COMPONENT. ON (B)(6) 2018, THE PRE-TREATMENT COMPUTED TOMOGRAPHY (CT) IMAGING SHOWED THAT THE MAXIMUM DIAMETER OF AN AORTIC ANEURYSM/ LESION WAS 54MM. THE FOLLOW UP CT SCANS SHOWED THAT THE MAXIMUM DIAMETER OF AN AORTIC ANEURYSM/ LESION INCREASED IN SIZE FROM 55 MM ON NOVEMBER 4, 2019 TILL 63MM ON (B)(6) 2022. ALSO, A TYPE III ENDOLEAK WAS DETERMINED. THE EVENT IS RELATED TO THE DEVICE AND THE ENDOVASCULAR PROCEDURE. THE EVENT IS ONGOING. NO TREATMENT WAS REPORTED. THE PHYSICIAN IS MONITORING THE PATIENT.

  Patient problems: Aneurysm; Clinical Endoleak; Vascular Dissection

  MAUDE report 15802719 ↗
• InjuryJul 30, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2018, THE PATIENT WAS IMPLANTED WITH CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESES TO TREAT A TYPE B AORTIC DISSECTION. IT WAS REPORTED THAT COMPUTED TOMOGRAPHY IMAGES DATED (B)(6) 2019, REVEALED A DISTAL TYPE I ENDOLEAK WITH DEVICE MALPOSITION ON THE DISTAL END. IT IS UNKNOWN IF THERE IS ANEURYSM SAC ENLARGEMENT. ON (B)(6) 2019, THE PHYSICIAN REINTERVENED AND IMPLANTED A CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESES AND EXTENDED DISTALLY. THE ENDOLEAK WAS RESOLVED AND THE PATIENT TOLERATED THE REINTERVENTION.

  Patient problems: Aortic Dissection

  MAUDE report 8844304 ↗
• InjuryApr 24, 2019Use of Device Problem; Insufficient Device Problem Information; Use of Device Problem; Insufficient Device Problem Information

  ON (B)(6) 2018, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF A THORACIC AORTIC DISSECTION WITH CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESES (TGU404015/15928245)-MOST ADJACENT TO THE TBE AORTIC COMPONENT. ON (B)(6) 2018, THE PRE-TREATMENT COMPUTED TOMOGRAPHY (CT) IMAGING SHOWED THAT THE MAXIMUM DIAMETER OF AN AORTIC ANEURYSM/ LESION WAS 54MM. ON (B)(6) 2018, DURING THE FOLLOW UP COMPUTED TOMOGRAPHY SCAN, A TYPE III ENDOLEAK ASSOCIATED WITH INSUFFICIENT OVERLAP PER IFU BETWEEN AN AORTIC EXTENDER (TGU404015/15928245) AND AN INVESTIGATIONAL AORTIC COMPONENT WAS DISCOVERED. THE MAXIMUM DIAMETER OF AN AORTIC ANEURYSM/ LESION WAS 51MM. THE PHYSICIAN WAS MONITORING THE PATIENT. ON (B)(6) 2019, THE 12 MONTHS FOLLOW UP CT CONFIRMED THE PRESENCE OF THE TYPE III ENDOLEAK BETWEEN AN AORTIC EXTENDER (TGU404015/15928245) AND AN INVESTIGATIONAL AORTIC COMPONENT. THE MAXIMUM DIAMETER OF AN AORTIC ANEURYSM/ LESION INCREASED IN SIZE FROM 50MM ON (B)(6) 2018 TILL 54MM ON (B)(6) 2019. ON (B)(6) 2019, THE PATIENT UNDERWENT THE ADDITIONAL PROCEDURE AND THE THORACIC AORTIC STENT GRAFT WAS PLACED. ON (B)(6) 2019, THE PATIENT DISCHARGED FROM THE HOSPITAL. NO FURTHER ADVERSE EVENTS HAVE BEEN REPORTED.

  Patient problems: Aneurysm; No Code Available

  MAUDE report 8547005 ↗
• InjuryApr 23, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2019, THE PATIENT WAS IMPLANTED WITH CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESES TO TREAT A DESCENDING THORACIC DISSECTION. IT WAS REPORTED THAT ON FOLLOW UP IMAGES COMPUTED TOMOGRAPHY IMAGES DATED (B)(6) 2019, REVEALED THE DISSECTION HAD EXTENDED TO THE CELIAC. THE TGU404015/18666716 DEVICE WAS THE MOST DISTALLY IMPLANTED. THERE WAS A REINTERVENTION ON (B)(6) 2019, TO EXTEND THE MOST DISTAL DEVICE. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Vascular Dissection

  MAUDE report 8541897 ↗
• InjuryJan 25, 2019Unintended Movement; Unintended Movement

  ON (B)(6) 2019, THE PATIENT UNDERWENT TREATMENT OF A THORACIC AORTIC ANEURYSM WITH A CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESIS. IT WAS REPORTED THE PHYSICIAN INTENDED TO IMPLANT THE DEVICE JUST DISTAL TO THE BOVINE ARCH. REPORTEDLY, THE DEVICE ¿JUMPED¿ FORWARD APPROXIMATELY 2CM AND PARTIALLY COVERING THE BOVINE ARCH. THE CAUSE OF THE DEVICE MOVEMENT IS REPORTEDLY UNKNOWN. IT WAS REPORTED THE DEVICE WAS LEFT IN THE PATIENT AND A BYPASS WAS PERFORMED TO PERFUSE THE BOVINE ARCH. THE PROCEDURE CONCLUDED WITHOUT ANY FURTHER COMPLICATIONS BEING REPORTED AND THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Aneurysm

  MAUDE report 8279261 ↗
• InjuryJan 10, 2019Compatibility Problem; Compatibility Problem

  ON (B)(6) 2014, THE PATIENT WAS TREATED FOR A THORACIC AORTIC ANEURYSM USING ENDOLOGIX STENT GRAFT AND CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESES. ON AN UNKNOWN DATE, IMAGING IDENTIFIED A TYPE III ENDOLEAK COMPONENT DISCONNECT BETWEEN THE ENDOLOGIX DEVICE AND A CTAG DEVICE (LOT NUMBER UNKNOWN). IT WAS REPORTED THE CAUSE OF TYPE III ENDOLEAK IS UNKNOWN. NO ANEURYSM ENLARGEMENT WAS REPORTED. ON (B)(6) 2018, A REINTERVENTION WAS PERFORMED BRIDGING THE TWO DEVICES. THE ENDOLEAK WAS REPORTEDLY RESOLVED AND THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Aneurysm

  MAUDE report 8238055 ↗
• MalfunctionSep 13, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2018, A CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESIS (ITEM/LOT NOT AVAILABLE) WAS TO BE IMPLANTED AS PART OF A THORACIC ENDOVASCULAR AORTIC REPAIR. ACCORDING TO THE REPORT, THE GORE® TAG® DEVICE COULD NOT BE ADVANCED TO ITS TARGET LOCATION. THE DECISION WAS MADE TO WITHDRAW THE DELIVERY CATHETER. UPON DEVICE WITHDRAWAL, THE GORE® DRYSEAL SHEATH (ITEM/LOT NOT AVAILABLE) VALVE WAS REPORTEDLY RUPTURED. AFTER THE DEVICE WAS WITHDRAWN, IT WAS REPORTED THE PHYSICIAN NOTICED A METAL PROTRUSION FROM THE LEADING OLIVE AT THE TIP OF THE DELIVERY CATHETER. THE SHEATH WAS REMOVED AND REPLACED, AND A NEW CTAG OF THE SAME CATALOG NUMBER WAS USED TO CONTINUE THE PROCEDURE. THE PROCEDURE WENT FORWARD TO COMPLETION WITHOUT ANY FURTHER REPORTED ISSUES. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Aneurysm

  MAUDE report 7875169 ↗

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