GORE TAG Conformable Thoracic Endoprosthesis TGU454515Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00733132618200), received between Jul 23, 2018 and Sep 28, 2023 — classified as 3 deaths, 7 injuries.

The most frequently reported specific device problem is “Fluid/Blood Leak” (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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjurySep 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2019, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF A ZONE 2 TYPE B DISSECTION WITH A CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESIS AND GORE® TAG® THORACIC BRANCH ENDOPROSTHESES. THE PATIENT TOLERATED THE PROCEDURE. CORE LAB PRE-TREATMENT IMAGING ON (B)(6) 2019, SHOWED THAT THE MAXIMUM ANEURYSM/ LESION WAS 67.2 MM. FROM (B)(6) 2019 TO (B)(6) 2022, THE CORE LAB IMAGING SHOWED THAT THE MAXIMUM ANEURYSM/ LESION DECREASED IN SIZE FROM 63MM TO 56MM. REPORTEDLY, ON (B)(6) 2023, A WORSENING OF THE THORACOABDOMINAL DILATION WAS NOTICED. ON (B)(6) 2023, THE PATIENT UNDERWENT ENDOVASCULAR PROCEDURE AND AN ABDOMINAL FENESTRATED VISCERAL AORTIC ENDOGRAFT WAS PLACED TO EXTEND THE REPAIR INTO THE ABDOMINAL AORTA DUE TO THE DISTAL DISEASE PROGRESSION. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Aneurysm expansion; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Vascular Dissection

  MAUDE report 17831697 ↗
• InjuryFeb 24, 2022Fluid/Blood Leak; Fluid/Blood Leak

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2011, THE PATIENT PRESENTED WITH A MID-DESCENDING THORACIC AORTIC ANEURYSM AND UNDERWENT TREATMENT UTILIZING A GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL (CTAG A/C). THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2017, THE PATIENT PRESENTED WITH A TYPE 1A ENDOLEAK FROM THE PREVIOUSLY PLACED DEVICE AND UNDERWENT REINTERVENTION UTILIZING A CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESIS (CTAG). THE TAG DEVICE WAS EXTENDED TO THE LEFT SUBCLAVIAN ARTERY. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2019, THE PATIENT PRESENTED WITH A TYPE 1B ENDOLEAK AND UNDERWENT REINTERVENTION UTILIZING A CONFORMABLE GORE® TAG®THORACIC ENDOPROSTHESIS (CTAG). THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2020, THE PATIENT PRESENTED WITH A CONTINUED TYPE 1A ENDOLEAK AND UNDERWENT REINTERVENTION UTILIZING A GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM (CTAG A/C). THE DEVICE WAS PLACED TO PARTIALLY COVER THE LEFT SUBCLAVIAN ARTERY DUE TO THE CONTINUED TYPE 1A ENDOLEAK. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2022. THE PATIENT PRESENTED WITH A TYPE 1A ENDOLEAK AND UNDERWENT A CAROTID-CAROTID AND CAROTID-SU

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13596433 ↗
• InjuryMay 3, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE THROUGH THE PIVOTAL STUDY FOR THE GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS (TBE DEVICE): ON (B)(6) 2019, THE PATIENT UNDERWENT TREATMENT OF A THORACIC AORTIC DISSECTION, ZONE 2 TYPE B DISSECTION (DISTAL TO THE LEFT COMMON CAROTID ARTERY OSTIUM AND PROXIMAL TO THE LEFT SUBCLAVIAN ARTERY) WITH A CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESIS. THE MAXIMUM AORTIC DIAMETER WITHIN TREATMENT SEGMENT 55.3MM (COMPUTED TOMOGRAPHY DATED (B)(6) 2019). IT WAS REPORTED THAT IMAGES DATED (B)(6) 2020, REVEALED AN EXPANDING THORACIC AORTIC ANEURYSM AFTER THE TYPE B DISSECTION, MAXIMUM AORTIC DIAMETER WITHIN TREATED SEGMENT 58MM. THERE WAS A REINTERVENTION ON (B)(6) 2020, AND A THORACIC AORTIC STENT GRAFT WAS IMPLANTED. THE PATIENT TOLERATED THE REINTERVENTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11762834 ↗
• DeathFeb 4, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  ON (B)(6) 2019, THE PATIENT WAS IMPLANTED WITH CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESES. IT WAS REPORTED THE PATIENT EXPIRED ON (B)(6) 2019. NO ADDITIONAL INFORMATION RELATED TO THIS EVENT WILL BE MADE AVAILABLE TO GORE. THEREFORE, FURTHER INVESTIGATION IS NOT POSSIBLE.

  Patient problems: Complaint, Ill-Defined

  MAUDE report 9668159 ↗
• InjuryMay 23, 2019Patient-Device Incompatibility; Patient-Device Incompatibility

  ON (B)(6) 2015, THIS PATIENT UNDERWENT ENDOVASCULAR REPAIR OF A DESCENDING THORACIC AORTIC ANEURYSM USING TWO CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESES. ON (B)(6) 2017, A PROXIMAL TYPE I ENDOLEAK WAS IDENTIFIED. ON THE SAME DAY, A PROCEDURE TO TREAT THE PROXIMAL TYPE I ENDOLEAK WAS PERFORMED. DETAILS OF THE TREATMENT WAS NOT REPORTED TO GORE. DURING THE PROCEDURE, A DISTAL TYPE I ENDOLEAK WAS ALSO DISCOVERED. ON (B)(6) 2018, AN INTERVENTION WAS PERFORMED TO TREAT THE DISTAL TYPE I ENDOLEAK, WHEREBY ENDOANCHORS WERE PLACED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8636886 ↗
• DeathApr 6, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2017 A PATIENT UNDERWENT TREATMENT OF A THORACIC AORTIC ANEURYSM, ZONE 2, MEASURING 46.2MM, WITH GORE® TAG® THORACIC BRANCH ENDOPROSTHESES AND A CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESIS. IT WAS REPORTED ALL DEVICES WERE IMPLANTED IN THE DESIRED LOCATIONS AND ALL COMPONENTS WERE PATENT, AS DEMONSTRATED BY ANGIOGRAPHY AT THE END OF THE PROCEDURE. ON (B)(6) 2017 THE PATIENT HAD A CT WHICH SHOWED A TYPE II ENDOLEAK, FROM THE INTERCOSTAL ARTERIES, ASSOCIATED WITH THE INVESTIGATIONAL GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS AORTIC COMPONENT. THE MAXIMUM TOTAL DIAMETER OF THE ANEURYSM WAS 53.1MM. ON (B)(6) 2019 THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT WITH ACUTE SHARP CHEST PAIN. A CTA WAS PERFORMED WHICH WAS CONCERNING FOR AN ENDOLEAK. IT SHOWED A NEW TYPE B DISSECTION WHICH WAS AT THE DISTAL TIP OF THE CTAG DEVICE WITH RETROGRADE FLOW INTO THE FALSE LUMEN, BUT NO EVIDENCE OF RUPTURE. ON (B)(6) 2019 THE PATIENT WENT INTO SUDDEN CARDIAC ARREST AND RETURN OF SPONTANEOUS CIRCULATION (ROSC) COULD NOT BE ACCOMPLISHED. THE PATIENT HAD A PRESUMED RUPTURE OF THE AORTIC ANEURYSM AND EXPIRED. HAD THE PATIENT NOT EXPIRED SO S

  Patient problems: Vascular Dissection

  MAUDE report 8489780 ↗
• InjuryFeb 28, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2015, THE PATIENT WAS IMPLANTED WITH CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESES TO TREAT A DESCENDING AORTIC DISSECTION RUPTURE. THE DISSECTION STARTED 5-10 CM DISTAL TO THE LEFT SUBCLAVIAN ARTERY. THE DEVICES WERE PLACED IN THE Z2 (DISTAL TO THE LEFT COMMON CAROTID ARTERY). PATIENT TOLERATED THE PROCEDURE. IT WAS REPORTED THAT ON (B)(6) 2018, AN EXPANDING OF THE CHRONIC TYPE B DISSECTION FROM (B)(6) 2015 WAS IDENTIFIED. THIS CHRONIC TYPE B DISSECTION LED TO A THORACOABDOMINAL ANEURYSM AND ON (B)(6) 2018, THE PATIENT UNDERWENT AN OPEN REPAIR OF A THORACOABDOMINAL AORTIC ANEURYSM USING A 26MM FOUR-BRANCH GELWEAVE GRAFT AND ADDITIONAL GRAFTS IN THE ILIAC ARTERIES. THERE WAS A SHORT SEGMENT OF NORMAL AORTA BETWEEN THE REPAIR AND THE ORIGINAL PROCEDURE WHERE GORE DEVICES HAVE BEEN USED. ON (B)(6) 2018, THE ABDOMINAL AREA WAS WASHOUT WITH EXPLORATORY LAPAROTOMY, SECONDARY ABDOMINAL CLOSURE. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2018 AND WAS DOING WELL. ON (B)(6) 2018, FOLLOW UP COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) SHOWED THAT THE MAXIMUM DIAMETER OF AORTIC ANEURYSM/LESION WAS 49MM. ON (B)(6) 2018, FOLLOW UP CTA SHOWED THAT THE MAXIMUM DIAMETER OF AORTIC A

  Patient problems: Aortic Dissection

  MAUDE report 8380208 ↗
• DeathOct 31, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2018, THE PATIENT WAS IMPLANTED WITH AN GORE® EXCLUDER® AAA ENDOPROSTHESIS AND A CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESES TO TREAT A THORACIC AORTIC DISSECTION. THE PATIENT HAD TORTUOUS ANATOMY. IT WAS REPORTED THAT PRIOR TO THE IMPLANT OF THE CONFORMABLE GORE® TAG® (TGU454515/(B)(4)), THE PATIENT HAD A BOVINE ARCH AND THE PHYSICIAN BYPASSED THE RIGHT CAROTID ARTERY TO THE LEFT CAROTID ARTERY AND THEN TO THE LEFT SUBCLAVIAN ARTERY (LSA). THE PHYSICIAN PLUGGED THE LSA AND LIGATED THE LEFT CAROTID VERTEBRAL ARTERY COMING OFF THE AORTIC ARCH. THE PHYSICIAN CONFIRMED THROUGH ANGIOGRAPH THAT THE CIRCLE OF WILLIS WAS INTACT AND THE BYPASSES WERE PATENT. THE PHYSICIAN THEN IMPLANTED A GORE® CONTRALATERAL LEG ENDOPROSTHESIS (PLC21000/(B)(4)) INTO THE INNOMINATE ARTERY AS A SNORKEL GRAFT. THE PHYSICIAN IMPLANTED THE CONFORMABLE GORE® TAG® (TGU454515/(B)(4)), BY ACCESS THROUGH THE BRACHIOCEPHALIC ARTERY. WHILE ATTEMPTING TO IMPLANT A SECOND CONFORMABLE GORE® TAG® (TGU454515/(B)(4)), THERE WAS DIFFICULTY GETTING THE GUIDEWIRE FROM THE INNOMINATE ARTERY INTO THE ASCENDING AORTA. THE GUIDEWIRE WOULD CONTINUE TO BE PULLED OUT OF THE ASCENDING AORTA INTO THE TRANSVERSE AORTA. THE

  Patient problems: Aortic Dissection

  MAUDE report 8026938 ↗
• InjurySep 6, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE THROUGH THE PIVOTAL STUDY FOR THE GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS (TBE DEVICE): ON (B)(6) 2018 A PATIENT UNDERWENT TREATMENT OF A THORACIC AORTIC ANEURYSM MEASURING 61 MM WITH GORE® TAG® THORACIC BRANCH ENDOPROSTHESES AND A CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESIS. ON (B)(6) 2018 THE PATIENT HAD A CEREBRAL VASCULAR ACCIDENT.

  Patient problems: Stroke/CVA

  MAUDE report 7852407 ↗
• InjuryJul 23, 2018Material Split, Cut or Torn; Material Split, Cut or Torn

  ON (B)(6) 2015, THIS PATIENT UNDERWENT ENDOVASCULAR REPAIR OF A DESCENDING THORACIC AORTIC ANEURYSM USING CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESES. ON (B)(6) 2017, A TYPE IB ENDOLEAK WAS IDENTIFIED. IT WAS REPORTED THAT THE ENDOLEAK WAS CAUSED BY PATIENT ANATOMY AND DISTAL END OF THE MOST DISTAL DEVICE NOT HAVING GOOD AORTIC SEAL. ON (B)(6) 2018, A REINTERVENTION OCCURRED WHEREBY A TWO GORE® EXCLUDER® AAA ENDOPROSTHESIS AORTIC EXTENDER COMPONENTS WERE IMPLANTED. AT THE CONCLUSION OF THE INTERVENTION, AN AORTOGRAM WAS PERFORMED AND A VERY SLOW ENDOLEAK WAS VISUALIZED. THE PROCEDURE WAS CONCLUDED WITH NO FURTHER ACTION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7712603 ↗

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-0291-2021 · Sep 9, 2020 · Open, Classified
  GORE TAG Conformable Thoracic Stent Graft with ACTIVE CONTROL System
• Z-0290-2021 · 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