GORE TAG Conformable Thoracic Endoprosthesis TGU404010Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00733132617739), received between Jul 24, 2018 and Dec 14, 2020 — classified as 7 injuries.

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

• InjuryDec 14, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2015, THE PATIENT WAS TREATED FOR A THORACIC AORTIC ANEURYSM. THREE CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESES WERE IMPLANTED. NO FURTHER INFORMATION WAS AVAILABLE. ON (B)(6) 2017, THE PATIENT WAS IMPLANTED WITH A CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESIS. NO INFORMATION IS AVAILABLE FOR THE CAUSE OF THE IMPLANT. ON (B)(6) 2020, THE PATIENT WAS IMPLANTED WITH A CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESIS. IT WAS USED TO PROXIMALLY EXTEND ONE OF THE PREVIOUSLY IMPLANTED DEVICES. THERE WAS NO INFORMATION AVAILABLE ON THE REASON THE DEVICE WAS IMPLANTED. THE PHYSICIAN STATED THAT THERE WAS DISEASE PROGRESSION. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 11004187 ↗
• InjuryOct 19, 2020Adverse 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) 2020 A PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN AORTIC ANEURYSM IN THE TAMBE STUDY. THE CASE INCLUDED THE USE OF A CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESIS. THE PATIENT EXHIBITED SPINAL CORD ISCHEMIA THE SAME DAY WHICH WAS TREATED WITH PLACEMENT OF A SPINAL DRAIN. REHABILITATION SERVICES WERE PROVIDED. ON (B)(6) 2020 PARAPLEGIA WAS CONFIRMED AND PHYSICAL THERAPY IS IN PROGRESS.

  Patient problems: Paraplegia

  MAUDE report 10702038 ↗
• InjuryAug 5, 2020Patient-Device Incompatibility; Patient-Device Incompatibility

  ON (B)(6) 2019, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF A THORACIC AORTIC ANEURYSM USING CONFORMABLE GORE TAG THORACIC ENDOPROSTHESES. A TGU343410 WAS DEPLOYED PROXIMAL, AND A TGU404010 WAS THEN PLACED DISTALLY. THE OVERLAP OF THE DEVICES WAS GREATER THAN 3 CM. ON (B)(6) 2019, 5-MONTH FOLLOW-UP CTA SCAN SHOWED A TYPE II ENDOLEAK WITH FILLING OF THE INTERCOSTALS ARTERIES. THE ANEURYSM INCREASED IN SIZE FROM 66 MM AT BASELINE TO 68 MM. THE PHYSICIAN OPTED TO REPEAT A CTA IN A YEAR. ON (B)(6) 2020, THE MORE RECENT CTA SHOWED CONTINUED GROWTH TO 76 MM. THERE ALSO APPEARED TO BE A TYPE III ENDOLEAK ON THE INNER CURVE OF THE TWO DEVICES. THERE APPEARED TO BE SOME ¿BIRD BEAKING¿ OF THE TGU404010 DEVICE. THIS WAS CONFIRMED WITH AN ANGIOGRAM ON (B)(6) 2020, AND THE ENTIRE STENTED SEGMENT WAS RELINED USING A SINGLE TGMR404015 DEVICE. FINAL ANGIOGRAMS SHOWED COMPLETE RESOLUTION OF THE ENDOLEAK.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10369156 ↗
• InjuryOct 22, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2019, THE PATIENT UNDERWENT ENDOVASCULAR REPAIR OF AN ABDOMINAL AORTIC ANEURYSM USING CONFORMABLE GORE® TAG® THORACIC (CTAG) ENDOPROSTHESES, GORE® EXCLUDER® AAA (EXCLUDER) ENDOPROSTHESES, AND GORE® VIABAHN® VBX BALLOON EXPANDABLE (VBX) ENDOPROSTHESES. IMAGES (DATE AND MODALITY) REVEAL A POSSIBLE UNKNOWN ENDOLEAK OR A ¿POSSIBLE GUTTER¿ (BETWEEN WHICH DEVICES IS UNKNOWN). THERE IS ANEURYSM SAC ENLARGEMENT, AMOUNT IS UNKNOWN. IT WAS REPORTED THAT ON (B)(6) 2019, THERE WAS A REINTERVENTION. THE PHYSICIAN EXTENDED THE SUPERIOR MESENTERIC ARTERY (SMA) WITH A GORE® VIABAHN® VBX BALLOON EXPANDABLE (VBX) ENDOPROSTHESES AND THEN PLACED A 40 MM CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESIS. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Aneurysm

  MAUDE report 9218828 ↗
• InjuryMar 12, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  ON (B)(6) 2016, THE PATIENT WAS IMPLANTED WITH CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESES TO TREAT A THORACOABDOMINAL AORTIC ANEURYSM. THE DEVICES WERE PLACED IN THE DISTAL DESCENDING THORACIC AORTA. PATIENT TOLERATED THE PROCEDURE. REPORTEDLY, THE PRE-TREATMENT COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) SHOWED THAT THE MAXIMUM DIAMETER OF THE AORTIC ANEURYSM/LESION WAS 65MM. IT WAS REPORTED THAT A DISSECTION ORIGINATED IMMEDIATELY ADJACENT BELOW THE DISTAL END OF THE IMPLANTED THORACIC ENDOGRAFT EXTENDING THROUGHOUT THE ABDOMINAL AORTA INTO THE COMMON ILIAC ARTERIES BILATERALLY. THE FIRST DEVICE (TGU404015/14222568) WAS DEPLOYED AT THE AREA OF SEVERE TORTUOSITY COVERING THE PROXIMAL TEAR BUT APPROXIMATELY 5 CM SUPERIOR TO THE CELIAC AXIS. THIS DEPLOYED NICELY. HOWEVER, THE PHYSICIAN WANTED TO EXTEND THIS DOWN THE CELIAC ACCESS TO EXCLUDE THE DISSECTION, THEREFORE A TGU404010/13263733 WAS USED AS A DISTAL EXTENSION. THE DEVICE WAS PLACED INTO THE AORTA AND SECOND ANGIOGRAM WAS PERFORMED DEMONSTRATING THE LOCATION OF THE CELIAC AXIS AGAIN AND THIS WAS CONFIRMED, AND THE SECOND DEVICE WAS DELIVERED 1 OR 2 CM SUPERIOR TO THE CELIAC ACCESS. FROM (B)(6) 2016 TO (B)(6) 2017, THE ANEURYSM

  Patient problems: Vascular Dissection

  MAUDE report 8414705 ↗
• InjuryMar 12, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2016, THE PATIENT WAS IMPLANTED WITH CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESES TO TREAT A THORACOABDOMINAL AORTIC ANEURYSM. THE DEVICES WERE PLACED IN THE DISTAL DESCENDING THORACIC AORTA. PATIENT TOLERATED THE PROCEDURE. REPORTEDLY, THE PRE-TREATMENT COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) SHOWED THAT THE MAXIMUM DIAMETER OF THE AORTIC ANEURYSM/LESION WAS 65MM. FROM (B)(6) 2016 TO (B)(6) 2017, THE ANEURYSM DIAMETER DECREASED IN SIZE FROM 59MM TO 43MM. HOWEVER, ON (B)(6) 2018, THE FOLLOW UP CTA SHOWED THAT THE MAXIMUM DIAMETER OF THE AORTIC ANEURYSM/LESION WAS 48.6MM. ON (B)(6) 2019, THE FOLLOW UP CTA SHOWED THAT THE MAXIMUM DIAMETER OF THE AORTIC ANEURYSM/LESION WAS 43MM. ADDITIONALLY, THE AORTIC AND LEFT ILIAC DISSECTION WAS IDENTIFIED. REPORTEDLY, THE ENDOVASCULAR TREATMENT AND AN OPEN PROCEDURE WERE NOT POSSIBLE DUE TO THE SIGNIFICANT RISK OF MORBIDITY AND MORTALITY. THE PHYSICIAN IS MONITORING THE PATIENT.

  Patient problems: Aneurysm

  MAUDE report 8414695 ↗
• InjuryJul 24, 2018Adverse 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) 2016, THE PATIENT UNDERWENT TREATMENT OF A THORACOABDOMINAL AORTIC ANEURYSM WHEREBY CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESES AND GORE® VIABAHN® ENDOPROSTHESES WITH HEPARIN BIOACTIVE SURFACE WERE IMPLANTED. ON (B)(6) 2018 THE PATIENT EXHIBITED A GUTTER LEAK AROUND THE LEFT RENAL ARTERY. ON (B)(6) 2018 THE PATIENT'S LEFT RENAL ARTERY WAS STENTED AND A LEFT RENAL ARTERY BRANCH IN THE GUTTER SPACE WAS EMBOLIZED. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Aneurysm

  MAUDE report 7715012 ↗

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