GORE TAG Conformable Thoracic Endoprosthesis TGU262110Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00733132617791), received between Aug 30, 2018 and Dec 30, 2021 — classified as 4 injuries.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryDec 30, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2011, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM USING A CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESIS (CTAG) AND A GORE® EXCLUDER® AAA ENDOPROSTHESIS CONTRALATERAL LEG COMPONENT. THE DEVICES WERE IMPLANTED TO CREATE AN AORTO-UNI-ILIAC CONFIGURATION. ON (B)(6) 2021, DURING FOLLOW UP, IT WAS DISCOVERED THAT THE CTAG DEVICE HAD MIGRATED DISTALLY, AND A TYPE I PROXIMAL ENDOLEAK WAS PRESENT. ON (B)(6) 2021, A REINTERVENTION OCCURRED WHEREBY A CONTRALATERAL LEG COMPONENT WAS IMPLANTED 4CM DISTAL TO THE LOWEST RENAL ARTERY, AND A TRUNK-IPSILATERAL LEG ENDOPROSTHESIS WAS IMPLANTED AT THE LEVEL OF THE LOWEST RENAL ARTERY. THE ENDOLEAK WAS RESOLVED AND THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Aneurysm

  MAUDE report 13118173 ↗
• InjuryMay 6, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2015, THIS PATIENT SUFFERED A TRAUMATIC THORACIC AORTIC TRANSECTION FOLLOWING A SKYDIVING ACCIDENT. THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT USING A GORE® CONFORMABLE TAG® THORACIC ENDOPROSTHESIS. ON (B)(6) 2020, THE PATIENT CONTACTED A GORE REPRESENTATIVE AND INDICATED THAT HE CHECKED HIMSELF INTO A HOSPITAL DUE TO COVID-19 LIKE SYMPTOMS. COMPUTED TOMOGRAPHY (CT) WAS PERFORMED, WHICH REVEALED POSSIBLE INFECTION IN THE AREA AROUND THE GORE® CTAG® DEVICE. THE PATIENT WAS NOT DIAGNOSED WITH ANY ILLNESS PRIOR TO THE CT SCAN. THE PATIENT WAS STARTED ON A REGIMEN OF ANTIBIOTICS. ON (B)(6) 2020, A BIOPSY/TISSUE WITH GRAM STAIN WAS PERFORMED. THE RESULTS INDICATED A RARE NUMBER STREPTOCOCCUS ANGINOSUS GROUP AND RARE TO SMALL NUMBER GRAM POSITIVE COCCI IN PAIRS. NO POLYMORPHONUCLEAR CELLS WERE SEEN. THEREFORE, ON (B)(6) 2020, THE PATIENT UNDERWENT AN EXPLANT OF THE CTAG® DEVICE, AND OPEN REPLACEMENT OF THE DESCENDING AORTA WITH AORTIC HOMOGRAFT, OMENTAL FLAP, AND INTERCOSTAL MUSCLE FLAP. THE PATIENT WILL BE MAINTAINED ON CEFTRIAXONE FOR SIX WEEKS POST-SURGERY.

  Patient problems: Bacterial Infection

  MAUDE report 10029066 ↗
• InjuryJan 23, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2019, THE PATIENT WAS IMPLANTED WITH CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESIS TO TREAT AN INTRAMURAL HEMATOMA. IT WAS REPORTED THE LEFT ANTERIOR OBLIQUE IMAGES DURING IMPLANT WERE POOR DUE TO THE PATIENT¿S MORBID OBESITY. THE FINAL IMAGING RUN REVEALED SLUGGISH FLOW THROUGH THE LEFT SUBCLAVIAN ARTERY. THE PHYSICIAN USED A FOGARTY CATHETER TO MAKE SURE THERE WERE NO CLOTS IN THE LEFT SUBCLAVIAN ARTERY. ON (B)(6) 2019, THE PATIENT HAD COMPLAINTS OF LEFT ARM PAIN. A COMPUTED TOMOGRAPHY (CT) REVEALED THAT A PORTION OF THE CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESIS WAS PARTIALLY COVERING THE LEFT SUBCLAVIAN ARTERY. THE PHYSICIAN REINTERVENED AND IMPLANTED A GORE® VIABAHN® VBX EXPANDABLE ENDOPROSTHESIS IN THE OSTIUM OF THE SUBCLAVIAN ARTERY AND BALLOONED THE AREA. THE PATIENT TOLERATED THE REINTERVENTION.

  Patient problems: Hematoma

  MAUDE report 9625105 ↗
• InjuryAug 30, 2018Patient-Device Incompatibility; Patient-Device Incompatibility

  ON (B)(6) 2015, THE PATIENT WAS TREATED FOR A THORACIC AORTIC ANEURYSM USING CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESES. IT WAS REPORTED METAL CLIPS (MANUFACTURER UNKNOWN) WERE LEFT BEHIND IN THE PATIENT¿S RIGHT FEMORAL ARTERY. IT WAS REPORTED ¿DAYS¿ AFTER THE SURGERY THE PATIENT WAS EXPERIENCING SEVERE ITCHING THAT HAS LASTED 3.5 YEARS. THE PATIENT REPORTEDLY UNDERWENT AN ALLERGY TEST AT A DERMATOLOGIST CONFIRMING THE PATIENT HAS A NICKEL ALLERGY. THE PATIENT IS REPORTEDLY BEING MONITORED.

  Patient problems: Pain

  MAUDE report 7835886 ↗

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