GORE TAG Conformable Thoracic Endoprosthesis TGU343410Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00733132617807), received between Sep 1, 2018 and Dec 2, 2022 — classified as 6 injuries.

The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (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.

• InjuryDec 2, 2022Leak/Splash; Insufficient Device Problem Information; Insufficient Device Problem Information

  ON (B)(6) 2018 THE PATIENT WAS IMPLANTED WITH CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESES. AS REPORTED, ON (B)(6) 2018, THE PATIENT PRESENTED WITH A POSSIBLE TYPE II OR TYPE III ENDOLEAK. AS REPORTED, THERE IS SOME CONCERN OVER ACCESS SITES ON THE PATIENT SO AN ANGIOGRAM IS BEING PLANNED IN ORDER TO DETERMINE THE TYPE OF LEAK AND BEST ACCESS AND DEVICE FOR USE IN TREATMENT. AS REPORTED, A REINTERVENTION WILL BE SCHEDULED BASED ON THE RESULTS.

  Patient problems: Clinical Endoleak

  MAUDE report 15909568 ↗
• InjuryJul 18, 2022Activation, Positioning or Separation Problem; Appropriate Device Problem Term/Code Not Available; Activation, Positioning or Separation Problem; Appropriate Device Problem Term/Code Not Available

  ON (B)(6) 2017 A PATIENT UNDERWENT TREATMENT OF A THORACIC AORTIC ANEURYSM, 45MM, ZONE 0, WITH GORE® TAG® THORACIC BRANCH ENDOPROSTHESES. A GORE® DRYSEAL FLEX SHEATH WAS UTILIZED FOR ACCESS. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2017 A DISTAL TYPE I ENDOLEAK WITH MAXIMUM ANEURYSM SAC DIMENSION 70 MM ASSOCIATED WITH A NON-COMMERCIALLY AVAILABLE AORTIC COMPONENT WAS DISCOVERED. ON (B)(6) 2017, THE ADDITIONAL PROCEDURE WAS DONE AND TWO CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESES AS A DISTAL EXTENSION TO THE AORTIC COMPONENT WERE PLACED. THE FOLLOW UP IMAGING DATED (B)(6) 2017, DETERMINED THAT THERE WAS NO PRESENCE OF ENDOLEAK, A NEW AORTIC DISSECTION OR RUPTURE. ON (B)(6) 2017, A RUPTURED AORTA WAS DETERMINED. IT WAS REPORTED BY SITE THAT THE EVENT WAS RELATED TO DEVICE AND ENDOVASCULAR PROCEDURE. ON (B)(6) 2017 THE PATIENT EXPIRED. ACCORDING TO THE PHYSICIAN, LIKELY INFECTION OF THE STENT GRAFT AND AORTA CAUSED THE AORTIC RUPTURE. THE PHYSICIAN DEFINITIVELY STATED THAT THE DEVICE WAS INFECTED, THAT IT HAD ERODED INTO THE ESOPHAGUS, AS DOCUMENTED BY VISUALIZATION OF THE STENT GRAFT DURING ESOPHAGOSCOPY. THEREFORE, THE AORTIC WALL WAS NO LONGER INTACT, AND THE PATIENT EXPIR

  Patient problems: Fistula; Ruptured Aneurysm; Unspecified Infection

  MAUDE report 15047971 ↗
• InjuryMay 11, 2022Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  ON (B)(6) 2016 A PATIENT UNDERWENT A TREATMENT OF A THORACOABDOMINAL AORTIC ANEURYSM ZONE 3, WITH TWO CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESES. CHIMNEY TECHNIQUE WAS USED WITH BRANCH VESSEL TREATMENT OF THE CELIAC, SUPERIOR MESENTERIC AND RIGHT RENAL ARTERIES. THE BRAND OF STENTS USED IN THE BRANCH VESSELS IS UNKNOWN. THE MAXIMUM AORTIC DIAMETER IN THE TREATMENT ZONE WAS 68MM BY CTA. THE FOLLOW UP CTA SHOWED THAT ON (B)(6) 2016 THE MAXIMUM AORTIC DIAMETER IN THE TREATMENT ZONE WAS 60.1MM. FROM (B)(6) 2017 TILL (B)(B) 2018 THE MAXIMUM AORTIC DIAMETER IN THE TREATMENT ZONE INCREASED IN SIZE FROM 62MM TO 64MM. IT WAS REPORTED THAT ON (B)(6) 2022, THE FOLLOW UP CTA SHOWED THAT THE MAXIMUM AORTIC DIAMETER WAS 89MM. REPORTEDLY, ON (B)(6) 2022, A GUTTER TYPE III ENDOLEAK RELATED TO THE ¿SNORKEL¿ PROCEDURE OF THE SUPERIOR MESENTERIC ARTERY (SMA) WAS NOTICED. DUE TO THE INFORMATION PROVIDED, THE ENDOLEAK WAS ATTRIBUTED TO THE GORE® TAG® THORACIC ENDOPROSTHESES. THERE WAS A POOR SEAL ALONG THE STENT USED FOR THE SNORKEL. THE PHYSICIAN DID NOT NOTICE ANY COMPONENT DISCONNECTION OR TEAR/DISRUPTION IN THE GRAFT MATERIAL. ON (B)(6) 2022, THE PATIENT UNDERWENT THE COIL EMBOLIZATION PROCEDUR

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

  MAUDE report 14366568 ↗
• 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 10368662 ↗
• InjuryAug 3, 2020Fracture; Fracture

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2015, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN THORACIC AORTIC ANEURYSM USING A CONFORMABLE GORE TAG THORACIC ENDOPROSTHESIS. FOLLOW UP SHOWED WHAT APPEARED TO BE A "FRACTURED OR DISCONNECTED" GORE TAG DEVICE. ON (B)(6) 2020, A REINTERVENTION OCCURRED WHEREBY THE DEVICE WAS RELINED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10359293 ↗
• InjurySep 1, 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 CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESES TO TREAT A NEW CHRONIC THORACIC AORTIC DISSECTION PROXIMAL TO THE EXISTING IMPLANTED DEVICES, NOT IN THE PREVIOUSLY TREATED AREA OF THE AORTA. PRIOR TO THIS PROCEDURE ON (B)(6) 2012, THE PATIENT WAS IMPLANTED WITH THREE GORE® TAG® THORACIC ENDOPROSTHESES TO TREAT A CHRONIC DISSECTION. ON (B)(6) 2017, THE PATIENT WAS IMPLANTED WITH GORE® EXCLUDER® AAA ENDOPROSTHESES IN THE ABDOMINAL AORTA, GORE® VIABAHN® ENDOPROSTHESES WERE IMPLANTED IN BILATERAL RENAL ARTERIES, THE CELIAC ARTERY AND SUPERIOR MESENTERIC ARTERY AS ¿CHIMNEYS¿ TO TREAT A NEW CHRONIC DISSECTION. IN ADDITION, ON AN UNKNOWN DATE, THE PATIENT HAD BARE METAL STENTS IMPLANTED IN BOTH FEMORAL ARTERIES. IT WAS REPORTED ACCESS WAS MADE THROUGH THE RIGHT FEMORAL ARTERY AND THAT AFTER DEPLOYING THE CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESIS (TGU343410/18359270) ON (B)(6) 2018, THE PROXIMAL END OF THE DEVICE PARTIALLY OPENED, APPROXIMATELY 30% OPEN, DOWN TO THE FIRST 1 CM OF THE DEVICE. THE REST OF THE DEVICE FULLY OPENED. THE PHYSICIAN ATTEMPTED TO BALLOON THE DEVICE AND IT REMAINED PARTIALLY OPEN. A GORE® EXCLUDER® CONTRALATERAL LEG

  Patient problems: Vascular Dissection

  MAUDE report 7840470 ↗

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