GORE TAG Conformable Thoracic Endoprosthesis TGU313115Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00733132617814), received between Nov 13, 2018 and Aug 9, 2024 — classified as 7 injuries, 1 malfunction.

The most frequently reported specific device problem is “Activation Failure” (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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 9, 2024Difficult to Remove; Migration; Difficult to Remove; Migration

  IT WAS REPORTED THAT ON (B)(6) 2024, A PATIENT WAS IMPLANTED WITH 31MM X 15CM GORE® TAG THORACIC ENDOPROSTHESIS (CTAG DEVICE) TO TREAT THORACIC AORTIC ANEURYSM. THE DISTANCE BETWEEN THE PATIENT'S ANEURYSM AND LEFT SUBCLAVIAN ARTERY IS 0.8MM. THEREFORE, THE PHYSICIAN PERFORMED A BYPASS FROM THE LEFT COMMON CAROTID ARTERY TO THE LEFT SUBCLAVIAN ARTERY TO EXTENT LANDING ZONE. A LIFETECH STENT WAS IMPLANTED PRIOR TO CTAG DEVICE IN THE SAME PROCEDURE. THE CTAG DEVICE WAS ADVANCED TO DISTAL LEFT COMMON CAROTID ARTERY. AFTER CONFIRMING THE POSITION WAS PRECISE VIA IMAGING, THE PHYSICIAN DEPLOYED CTAG DEVICE. THE DEPLOYMENT LINE WAS TOTALLY PULLED OUT AND THE STENT WAS SUCCESSFULLY EXPANDED. DURING WITHDRAWING DELIVERY SYSTEM, A STRONG RESISTANCE WAS FELT, AND THE DELIVERY SYSTEM COULDN'T BE REMOVED. THE PHYSICIAN TRIED TO EXCHANGE GUIDEWIRES AND PULL WITH THE SNARE, BUT THE DELIVERY SYSTEM STILL COULDN'T BE REMOVED. FINALLY, THE PHYSICIAN PULLED DELIVERY SYSTEM WITH STRONG FORCE, IT WAS REMOVED OUT. HOWEVER, THE SLEEVE WHICH SHOULD HAVE REMAINED IMPLANTED BETWEEN THE STENT AND THE VESSEL WALL WAS REMOVED OUT WITH DELIVERY SYSTEM. THE STENT WAS MIGRATED TO DESCENDING AORTA. ANOTHER DEVICE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19946900 ↗
• InjurySep 13, 2022Adverse 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) 2017, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF A THORACIC AORTIC DISSECTION WITH CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESES (TGU313115/16209151)-MOST ADJACENT TO THE TBE AORTIC COMPONENT. ON (B)(6) 2022, COMPUTED TOMOGRAPHY AND ULTRASOUND IMAGING WERE PERFORMED. ACCORDING TO THE EVENT REPORT THERE WAS AN EXPANSION OF THE "EXCLUDED ANEURYSMAL SAC" FROM 52MM TO 58MM. ON (B)(6) 2022, FOLLOW UP COMPUTED TOMOGRAPHY WAS CONDUCTED AND SHOWED AN UNCHANGED APPEARANCE OF THE EXCLUDED ANEURYSM SAC AND RESIDUAL DISSECTION FLAP. STABLE AORTIC MEASUREMENTS WERE OBSERVED WITH A MAXIMUM DIAMETER OF 58 MM AT THE MID DESCENDING THORACIC LEVEL. AS REPORTED THE PATIENT WAS ASYMPTOMATIC AND THERE ARE NO PLANS TO INTERVENE AT THIS TIME. THE PLAN IS TO CONTINUE TO MONITOR THE PATIENT STATUS. THE EVENT IS ONGOING.

  Patient problems: Aneurysm expansion

  MAUDE report 15412254 ↗
• InjurySep 15, 2020Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  ON (B)(6) 2015, A PATIENT UNDERWENT A DESCENDING THORACIC AORTIC ANEURYSM TREATMENT USING CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESES. REPORTEDLY, THE DEVICES WERE PLACED IN THE ZONE 4 (DISTAL DESCENDING THORACIC AORTA). PATIENT TOLERATED THE PROCEDURE. IT WAS REPORTED THAT THE PATIENT HAD A HISTORY OF THE OPEN VISCERAL DEBRANCHING PROCEDURE. PRE-TREATMENT COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) SHOWED THAT THE MAXIMUM DIAMETER OF AN AORTIC ANEURYSM/LESION WAS 60MM. ON (B)(6) 2015, THE FOLLOW-UP CTA SHOWED THAT THE WAS 73MM. ON (B)(6) 2016, THE MAXIMUM DIAMETER OF AN AORTIC ANEURYSM/LESION WAS 53MM. ON (B)(6) 2017, THE MAXIMUM DIAMETER OF AN AORTIC ANEURYSM/LESION WAS 55MM. FROM (B)(6) 2018 TO (B)(6) 2020, THE MAXIMUM DIAMETER OF AN AORTIC ANEURYSM/LESION INCREASED IN SIZE FROM 49MM TO 63MM. REPORTEDLY, ON (B)(6) 2020, THE PATIENT HAD AN EXPANSION OF THE DISTAL DESCENDING THORACIC AORTA WITH THE RUPTURE INTO THE RIGHT CRUS OF THE DIAPHRAGM. ACCORDING TO THE INFORMATION PROVIDED, THE PHYSICIAN BELIEVED THAT A TYPE V ENDOLEAK CAUSED THE ANEURYSM ENLARGEMENT, AND THE ANEURYSM RUPTURE AT THE TREATED SEGMENT OF THE THORACIC AORTIC ANEURYSM INTO THE LEVEL OF THE RIGHT CRUS OF THE DIAPHR

  Patient problems: Aneurysm

  MAUDE report 10538539 ↗
• InjuryAug 5, 2020Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2016, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR A TYPE B DISSECTION AND WAS IMPLANTED WITH GORE® TAG® CONFORMABLE THORACIC STENT GRAFT IN ZONE 3 OF THE THORACIC AORTA. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2020, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR A ZONE ONE THORACIC AORTIC ARCH DISSECTION WHICH HAD CONTINUED TO DEGENERATE AND FORM A FALSE LUMEN ANEURYSM. A FROZEN ELEPHANT TRUNK AND A GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WERE IMPLANTED AND A OPEN HYBRID ARCH REPAIR WAS PERFORMED. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Vascular Dissection

  MAUDE report 10371087 ↗
• InjuryJan 7, 2020Improper or Incorrect Procedure or Method; Activation Failure; Improper or Incorrect Procedure or Method; Activation Failure

  IT WAS REPORTED TO GORE THAT ON (B)(6) 2019, A CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESIS WAS TO BE USED FOR TREATMENT OF A THORACIC AORTA ULCERATION. WHEN THE DEVICE WAS ADVANCED TO THE TARGET LESION THROUGH GORE DRYSEAL SHEATH(22F), THE PHYSICIAN INITIATED THE DEPLOYMENT LINE, RESISTANCE WAS REPORTEDLY FELT WHEN ABOUT 2CM FIBER WAS PULLED OUT. THE PHYSICIAN CONTINUOUSLY PULLED OUT THE DEPLOYMENT LINE AND THE DISTAL END OF THE ENDOPROSTHESIS EXPANDED. THE PROXIMAL END OF THE ENDOPROSTHESIS WAS STILL CONSTRAINED. THEN THE PHYSICIAN PULLED OUT THE DEPLOYMENT LINE WITH EXCESSIVE FORCE , THE DELIVERY CATHETER WAS PULLED DOWNWARDS AND THE EXPANDED PART OF THE ENDOPROSTHESIS WAS SHRUNK SUDDENLY .THE PROXIMAL END OF THE ENDOPROSTHESIS WAS STILL CONSTRAINED AND COULD NOT EXPAND. IMMEDIATE EXTERNAL FLOW WAS PERFORMED TO ENSURE BLOOD SUPPLY TO THE VISCERAL ARTERIES AND LOWER LIMBS, AND THE CONTRALATERAL FEMORAL ARTERY WAS PUNCTURED AND THE BALLOON WAS DILATED . THE CONSTRAINED PART OF THE ENDOPROSTHESIS COULD NOT EXPAND. THE PATIENT WAS TRANSFERRED TO CARDIOTHORACIC SURGERY FOR THORACOTOMY AND THE PHYSICIAN CUT THE DEPLOYMENT LINE TO EXPAND THE ENDOPROSTHESIS .THE PHYSICIAN CUT OFF THE

  Patient problems: No Code Available

  MAUDE report 9561854 ↗
• InjuryJan 3, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6), 2016 A PATIENT UNDERWENT TREATMENT OF A DESCENDING THORACIC ANEURYSM WITH TWO CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESES. ON (B)(6) 2020 A REINTERVENTION TOOK PLACE TO ADDRESS DISTAL MIGRATION OF APPROXIMATELY 5MM. AN ADDITIONAL CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESIS WAS IMPLANTED PROXIMALLY. THE REASON FOR THE DISTAL MIGRATION WAS ASKED, BUT IS UNKNOWN. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9547631 ↗
• InjuryFeb 14, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2016, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR A THORACIC AORTIC ARCH ANEURYSM AND WAS IMPLANTED WITH A CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESIS. IT WAS REPORTED THAT PLACEMENT WAS JUST DISTAL TO THE INNOMINATE ARTERY WITH COVERAGE OF THE LEFT SUBCLAVIAN ARTERY (LSA). THE LSA WAS REPORTED TO HAVE BEEN BYPASSED BUT NOT TRANSPOSED. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2019, THE PATIENT UNDERWENT REINTERVENTION FOR TREATMENT OF A TYPE II ENDOLEAK ORIGINATING FROM THE LSA. AN ADDITIONAL CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESIS WAS PLACED TO RELINE THE ORIGINAL GRAFT AND REINFORCE THE RADIAL FORCE. THE PATIENT TOLERATED THE PROCEDURE. CONCLUSION ANGIOGRAPHY WAS UNABLE TO DETERMINE IF THE ENDOLEAK WAS RESOLVED.

  Patient problems: Aneurysm

  MAUDE report 8338830 ↗
• InjuryNov 13, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2013, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR A DISSECTION OF THE DESCENDING THORACIC AORTA AND WAS IMPLANTED WITH TWO CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESES. AN UNKNOWN COOK DEVICE WAS ALSO IMPLANTED AND POSITIONED AS THE MOST DISTAL DEVICE. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2018, THE PATIENT UNDERWENT AN MRI AND CT OF THE HEAD AND NECK FOR NEW ONSET HOARSENESS WHICH SHOWED A NEW LARGE ARCH ANEURYSM WHICH APPEARED TO BE PARTIALLY THROMBOSED. ON (B)(6) 2018, AN EXTENSION OF THE DISSECTION BOTH PROXIMALLY AND DISTALLY WAS REPORTED. PROXIMALLY THE DISSECTION HAD EXTENDED TO THE LEFT COMMON CAROTID ARTERY (LCCA) WITH THE FALSE LUMEN HAVING EXTENDED AND COVERING THE LCCA. DISTALLY THE EXTENSION EXTENDED DOWN TO THE INFRARENAL ABDOMINAL AORTA. THE PATIENT UNDERWENT REINTERVENTION AND A LCCA TO LEFT SUBCLAVIAN ARTERY (LSA) BYPASS WAS PERFORMED AND AN ADDITIONAL CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESIS WAS IMPLANTED PROXIMALLY WITH COVERAGE OF THE LSA AND LCCA. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Thrombosis

  MAUDE report 8066982 ↗

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