GORE TAG Conformable Thoracic Endoprosthesis TGU373710Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00733132617722), received between May 10, 2018 and Aug 26, 2020 — classified as 1 death, 5 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (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.

• InjuryAug 26, 2020Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  ON (B)(6) 2020 THE PATIENT UNDERWENT OPEN TREATMENT OF A RUPTURED ABDOMINAL AORTIC ANEURYSM USING CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESES. ON JULY 27, 2020 THE PHYSICIAN MADE THE FIELD SALES ASSOCIATE AWARE OF AN ENDOLEAK OBSERVED ON IMAGING. THE ENDOLEAK WAS SUSPECTED TO BE EITHER A TYPE III ENDOLEAK OR A GUTTER LEAK. ON (B)(6) 2020 A REINTERVENTION WAS PERFORMED TO TREAT THE ENDOLEAK. REPORTEDLY IT WAS SUSPECTED THAT THE PATIENT HAD A GUTTER LEAK ORIGINATING FROM THE AREA WHERE THE LEFT RENAL ARTERY STENT WAS PLACED PARALLEL (USING A PERISCOPE TECHNIQUE) ALONGSIDE THE 37MMX10CM CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESIS. A RETROGRADE LEAK OFF OF THE LEFT RENAL ARTERY STENT WAS ALSO NOTED. THE PHYSICIAN PLACED A 37MMX10CM GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM AND A BARD 6MMX58MM LIFESTREAM STENT TO TREAT THE ENDOLEAK. THE GUTTER LEAK WAS COIL EMBOLIZED USING VARIOUS COILS. AN ADDITIONAL 8MM STENT WAS PLACED IN THE PATIENT'S LEFT RENAL ARTERY. THE ENDOLEAK APPEARED TO BE RESOLVED. THERE WERE NO FURTHER REPORTED ISSUES. THE PATIENT TOLERATED THE REINTERVENTION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10452391 ↗
• InjuryMar 17, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THERE WAS ANEURYSM SAC ENLARGEMENT (AMOUNT OF ENLARGEMENT IS UNKNOWN). THE CAUSE OF THE ENDOLEAK IS UNKNOWN. ON (B)(6) 2020, THE DEVICES WERE EXPLANTED AND OPEN SURGICAL CONVERSION WAS PERFORMED. THE PATIENT TOLERATED THE REINTERVENTION.

  Patient problems: Aneurysm

  MAUDE report 9843704 ↗
• InjuryNov 2, 2019Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2019 A PATIENT WAS UNDERGOING TREATMENT OF AN ANEURYSMAL TYPE B THORACIC AORTIC DISSECTION, ZONE 2 WITH GORE® TAG® THORACIC BRANCH ENDOPROSTHESES AND A CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESIS AS DISTAL EXTENSION TO AORTIC COMPONENT. THE PRE-TREATMENT MAXIMUM AORTIC DIAMETER WITHIN THE TREATED SEGMENT HAS NOT BEEN RECORDED IN THE CLINICAL STUDY DATABASE. ACCORDING TO THE REPORT ALL DEVICES WERE POSITIONED AND IMPLANTED WITHOUT ISSUE. ON (B)(6) 2019 AN ASYMPTOMATIC, UNSPECIFIED ENDOLEAK WAS REPORTED. THERE WAS NO ANEURYSM ENLARGEMENT REPORTEDLY ASSOCIATED WITH THE ENDOLEAK. ON (B)(6) 2019 AN EMBOLIZATION PROCEDURE WAS PERFORMED TO ADDRESS THE ENDOLEAK. FOLLOWING THE PROCEDURE THE ENDOLEAK WAS RESOLVED.

  Patient problems: No Known Impact Or Consequence To Patient; Not Applicable

  MAUDE report 9270517 ↗
• DeathJun 13, 2019Patient-Device Incompatibility; Patient-Device Incompatibility

  ON (B)(6) 2014, THIS PATIENT UNDERWENT ENDOVASCULAR REPAIR OF A THORACOABDOMINAL AORTIC ANEURYSM USING GORE® TAG® THORACIC ENDOPROSTHESES. ON (B)(6) 2016, A PROCEDURE OCCURRED WHEREBY A GORE® VIABAHN® ENDOPROSTHESIS WAS IMPLANTED IN THE SUPERIOR MESENTERIC ARTERY TO EXTEND A PREVIOUSLY IMPLANTED GRAFT (UNKNOWN MANUFACTURER). ON (B)(6) 2019, COMPUTED TOMOGRAPHY IMAGING SHOWED AN UNSTABLE TYPE II ENDOLEAK AT THE LEVEL OF THE MID/DISTAL THORACIC AORTA, WITH EVIDENCE OF RUPTURE OF THE ANEURYSM AND BLEEDING INTO THE LEFT PLEURAL SPACE. AFTER DISCUSSION WITH THE PATIENT ABOUT ENDOVASCULAR REPAIR VS OPEN REPAIR VS COMFORT MEASURES, THE PATIENT ELECTED FOR PALLIATIVE CARE CONSULT AND TO PURSUE COMFORT MEASURES. THE PATIENT EXPIRED ON (B)(6) 2019.

  Patient problems: Death

  MAUDE report 8695861 ↗
• InjuryDec 21, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2016, THE PATIENT UNDERWENT ENDOVASCULAR REPAIR OF A THORACIC AORTIC ANEURYSM USING A CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESES. IT WAS REPORTED THAT ON (B)(6) 2018, THE PATIENT PRESENTED WITH HEMOLYSIS. A TYPE III ENDOLEAK WITH COMPONENT SEPARATION WAS IDENTIFIED. THERE WAS EXCESSIVE OVERLAP BETWEEN THE ORIGINAL IMPLANTED CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESES (TGU373710/12562071 AND TGU373710/14491031) AND THEREFORE THE TGU454510/14820255 DISCONNECTED FROM BOTH IMPLANTED DEVICES. THE PHYSICIAN REINTERVENED AND BRIDGED THE COMPONENT DISCONNECTION BY IMPLANTING A CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESIS (TGU454520/18712623). THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Aneurysm

  MAUDE report 8192249 ↗
• InjurySep 13, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2018, A PATIENT UNDERWENT ENDOVASCULAR TREATMENT IN THE THORACIC AORTA, ZONE 2, WITH GORE® TAG® THORACIC BRANCH ENDOPROSTHESES AND CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESES. THE PATIENT TOLERATED THE INITIAL PROCEDURE. IT WAS REPORTED THAT DURING THE INITIAL PROCEDURE A TYPE II ENDOLEAK WAS DETERMINED. ON (B)(6) 2018, THE PATIENT UNDERWENT THE ADDITIONAL PROCEDURE WITH A STENT PLACEMENT. THE EVENT IS ONGOING. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2018.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7875403 ↗
• MalfunctionMay 10, 2018Break; Detachment Of Device Component

  THE "NOSE CONE" (TIP) BROKE OFF THE INSTRUMENT INSIDE OF THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 7506279 ↗

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