GORE EXCLUDER AAA Endoprosthesis with C3 Delivery RMT311415Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00733132610754), received between Oct 6, 2018 and Oct 2, 2023 — classified as 2 deaths, 6 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 reports).

2 other recalls cover devices cleared under the same FDA submission (P020004); 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.

• DeathOct 2, 2023Migration; Migration

  ON (B)(6) 2012, PATIENT UNDERWENT AN UNKNOWN ENDOVASCULAR PROCEDURE UTILIZING GORE® EXCLUDER® AAA ENDOPROSTHESIS. ON (B)(6) 2023, PATIENT PRESENTED WITH A RUPTURED ANEURYSM. A TYPE 1 ENDOLEAK WAS ALSO NOTED. PATIENT CAME INTO THE OFFICE VERY SICK AND WAS IN BAD CONDITION. PATIENT WAS NOT A CANDIDATE FOR STENT GRAFT REPAIR DUE TO HIS POOR CONDITION. ON (B)(6) 2023, PATIENT UNDERWENT OPEN REPAIR SURGERY. PATIENT PASSED AWAY LATER THAT DAY. FSA ALSO REPORTED PATIENT WAS NOT SEEN AT THE OFFICE FOR A LONG TIME. IT WAS REPORTED HE WAS LOST IN SURVEILLANCE. RUPTURE WAS OBSERVED NEAR THE TRUNK-IPSILATERAL COMPONENT. PHYSICIAN ATTRIBUTES RUPTURE TO THE TYPE 1 ENDOLEAK. PHYSICIAN DID NOT COMMENT ON CAUSE OF DEATH AND NO FURTHER INFORMATION ON CAUSE IS AVAILABLE. NO FURTHER INFORMATION ABOUT THE CASE AND PATIENT IS AVAILABLE.

  Patient problems: Clinical Endoleak; Ruptured Aneurysm

  MAUDE report 17851424 ↗
• InjuryAug 24, 2023Migration; Migration

  IT WAS REPORTED THAT ON (B)(6) 2010, A PATIENT PRESENTING WITH AN ABDOMINAL AORTIC ANEURYSM WAS TREATED WITH A GORE® EXCLUDER® AAA ENDOPROSTHESIS. ON (B)(6) 2011, POST-OPERATIVE MAXIMUM AORTIC ANEURYSM DIAMETER MEASURED 76 MM VIA CT IMAGING. ON (B)(6) 2018, MAXIMUM AORTIC ANEURYSM DIAMETER MEASURED 55 MM VIA CT IMAGING (THIS WAS THE SMALLEST DIAMETER RECORDED IN PATIENT FOLLOW-UPS). ON (B)(6) 2019, MAXIMUM AORTIC ANEURYSM DIAMETER INCREASED TO 58 MM VIA CT IMAGING. ON (B)(6) 2019, AN ADDITIONAL DEVICE WAS IMPLANTED TO TREAT STENT MIGRATION AND ANEURYSM GROWTH. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Aneurysm

  MAUDE report 17609891 ↗
• InjuryFeb 13, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  ON (B)(6) 2013, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM MEASURED 51.2MM AND WAS IMPLANTED WITH GORE® EXCLUDER® AAA ENDOPROSTHESES. THE PATIENT TOLERATED THE INITIAL PROCEDURE. ON AN UNKNOWN DATE IN (B)(6) 2022, THE ABDOMINAL AORTIC ANEURYSM RUPTURE WAS REPORTED. ON AN UNKNOWN DATE IN (B)(6) 2022, THE PATIENT EXPIRED. THE FOLLOW UP IMAGES WERE NOT PROVIDED. NO ADVERSE EVENTS OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL TREATMENTS WERE PERFORMED. THE CAUSE OF RUPTURE IS UNKNOWN. THE DATE AND THE CAUSE OF DEATH IS UNKNOWN.

  Patient problems: Aneurysm; Ruptured Aneurysm

  MAUDE report 16368680 ↗
• InjuryAug 20, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2012, THE PATIENT PRESENTED WITH AN UNSPECIFIED AORTIC ANEURYSM AND UNDERWENT TREATMENT UTILIZING A GORE® EXCLUDER® AAA ENDOPROSTHESIS. THE PROCEDURE WAS COMPLETED WITHOUT ISSUE. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2021, THE PATIENT UNDERWENT REINTERVENTION FOR REVISION OF THE PREVIOUSLY PLACED GORE® EXCLUDER® AAA ENDOPROSTHESIS UTILIZING TWO GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS WITH ACTIVE CONTROL (CXT A/C) AND A GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX). THE PHYSICIAN PLACED THE TWO CXT A/C DEVICES PROXIMAL AND UTILIZED THE SANDWICH GRAFT TECHNIQUE WITH THE VBX DEVICE PLACED IN THE LEFT RENAL ARTERY. THE PATIENT TOLERATED THE PROCEDURE. FURTHER INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12351154 ↗
• DeathJun 9, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED ON (B)(6) 2011, WITH AN ABDOMINAL AORTIC ANEURYSM THAT WAS TREATED WITH GORE¿ EXCLUDER¿ AAA ENDOPROSTHESIS. THE PATIENT PRESENTED WITH AN AORTO-ENTERIC FISTULA ON AN UNKNOWN DATE THAT CAUSED INFECTION OF THE IMPLANTED DEVICES. THE INFECTION WAS TREATED WITH ANTIBIOTICS. THE PATIENT EXPIRED ON (B)(6) 2021, DUE TO MYOCARDIAL INFARCTION AND SEPSIS.

  Patient problems: Fistula

  MAUDE report 11969837 ↗
• InjuryJun 10, 2020Patient-Device Incompatibility; Patient-Device Incompatibility

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2013, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM MEASURING 80 MM IN DIAMETER AND WAS TREATED WITH GORE® EXCLUDER® AAA ENDOPROSTHESES. ON (B)(6) 2018, FOLLOW-UP COMPUTED TOMOGRAPHY ANGIOGRAPHY IMAGING REVEALED AN ANEURYSM DIAMETER OF 102 MM. ON (B)(6) 2019, A FOLLOW-UP OFFICE VISIT ON THE PATIENT WAS PERFORMED WITHOUT IMAGING. ON (B)(6) 2020, FOLLOW-UP ULTRASOUND EXAMINATION SHOWED AN ANEURYSM DIAMETER OF 106 MM DUE TO A REPORTEDLY KNOWN TYPE II ENDOLEAK FIRST IDENTIFIED ON (B)(6) 2013. ON (B)(6) 2020, THE PATIENT WAS CONVERTED TO OPEN SURGERY DURING WHICH ALL GORE® EXCLUDER® ENDOPROSTHESES WERE REPORTEDLY EXPLANTED.

  Patient problems: Aneurysm

  MAUDE report 10141374 ↗
• InjuryFeb 4, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2012, THE PATIENT WAS IMPLANTED WITH A GORE® EXCLUDER® AAA ENDOPROSTHESES TO TREAT AN ABDOMINAL AORTIC ANEURYSM. THE PATIENT TOLERATED THE PROCEDURE. IT WAS REPORTED THAT COMPUTED TOMOGRAPHY (CT) IMAGES DATED (B)(6) 2018, REVEALED A PROXIMAL TYPE I ENDOLEAK. IT IS UNKNOWN IF THERE IS ANEURYSM SAC ENLARGEMENT. THE PHYSICIAN REINTERVENED ON (B)(6) 2019. THE PHYSICIAN IMPLANTED AN ADDITIONAL GORE® EXCLUDER® AAA ENDOPROSTHESIS (RMT DEVICE 28.5X14.5X18CM) DEPLOYED UP TO THE SUPERIOR MESENTERIC ARTERY AND THERE WERE TWO GORE® VIABAHN® PLACED IN EACH RENAL ARTERY. THE ENDOLEAK WAS RESOLVED AND THE PATIENT TOLERATED THE REINTERVENTION.

  Patient problems: Aneurysm

  MAUDE report 8300937 ↗
• InjuryOct 6, 2018Patient-Device Incompatibility; Patient-Device Incompatibility

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2013, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) MEASURING 80 MM IN DIAMETER AND WAS TREATED WITH GORE® EXCLUDER® AAA ENDOPROSTHESES. ON (B)(6) 2017, ULTRASOUND EXAMINATION REVEALED AN ANEURYSM DIAMETER OF 88 MM. ON (B)(6) 2017, ULTRASOUND EXAMINATION IDENTIFIED AN ANEURYSM DIAMETER OF 90 MM. ON (B)(6) 2018, COMPUTED TOMOGRAPHY ANGIOGRAPHY IMAGING CONFIRMED AN ANEURYSM DIAMETER OF 94 MM. ON (B)(6) 2018, AN ADDITIONAL GRAFT WAS IMPLANTED DURING AN ENDOVASCULAR PROCEDURE TO TREAT A PERSISTING TYPE 1A OR TYPE II ENDOLEAK.

  Patient problems: No Code Available

  MAUDE report 7941233 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P020004. One submission often covers many models, so check the product and lot details in each record.

• Z-0996-2020 · Jan 6, 2020 · Terminated
  GORE EXCLUDER Iliac Branch Endoprosthesis (IBE)
• Z-0995-2020 · Jan 6, 2020 · Terminated
  GORE EXCLUDER AAA Endoprosthesis