GORE EXCLUDER AAA Endoprosthesis with C3 Delivery RMT231214Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00733132610518), received between Jan 15, 2019 and Sep 18, 2024 — classified as 7 injuries.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (3 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjurySep 18, 2024Fluid/Blood Leak; Fluid/Blood Leak

  ON (B)(6) 2014, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM MEASURING 53MM IN DIAMETER AND WAS IMPLANTED WITH GORE® EXCLUDER® AAA ENDOPROSTHESIS FEATURING C3® DEPLOYMENT SYSTEM. THE PATIENT TOLERATED THE PROCEDURE AND WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2014. ON (B)(6) 2014, FOLLOW-UP COMPUTED TOMOGRAPHY DETERMINED THE MAXIMUM DIAMETER OF THE ANEURYSM MEASURED 55MM. ON (B)(6) 2024, THE PATIENT WAS REPORTED TO HAVE A TYPE II ENDOLEAK RELATED TO THE AORTIC DEVICE OR PROCEDURE. FOLLOW-UP ULTRASOUND DETERMINED THE MAXIMUM DIAMETER OF THE ANEURYSM MEASURED 68 MM. THE CAUSE IS BELIEVED TO HAVE BEEN DUE TO DEVICE MIGRATION, COUPLED WITH THE PATIENT BEING REPORTED TO HAVE A SHORT AORTIC NECK. ON (B)(6) 2024, THE PATIENT IS SCHEDULED TO UNDERGO REINTERVENTION WHEREIN IR EMBOLIZATION OF THE TYPE II ENDOLEAK WITH ANESTHESIA IS TO BE PERFORMED.

  Patient problems: Aneurysm expansion

  MAUDE report 20251924 ↗
• InjuryJul 10, 2023Patient-Device Incompatibility; Insufficient Device Problem Information; Patient-Device Incompatibility; Insufficient Device Problem Information

  IT WAS REPORTED THAT ON (B)(6) 2011, A PATIENT PRESENTING WITH AN ABDOMINAL AORTIC ANEURYSM WAS TREATED WITH A GORE® EXCLUDER® AAA ENDOPROSTHESIS. ON (B)(6) 2011, THE MAXIMUM DIAMETER OF THE AORTIC ANEURYSM MEASURED 47 MM VIA COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) IMAGING. ON (B)(6) 2016, THE MAXIMUM DIAMETER OF THE AORTIC ANEURYSM MEASURED 44 MM VIA CTA IMAGING. ON (B)(6) 2016, THE MAXIMUM DIAMETER OF THE AORTIC ANEURYSM MEASURED 59 MM VIA CTA IMAGING. ON (B)(6) 2022, THE PATIENT WAS TREATED WITH THE IMPLANTATION OF AN ADDITIONAL CONTRALATERAL LEG ENDOPROSTHESIS IN THE RIGHT COMMON ILIAC ARTERY IN RESPONSE TO A RISK OF A TYPE IB ENDOLEAK. THE PHYSICIAN BELIEVES THAT A SHORT LANDING ZONE LESS THAN 1 CM CONTRIBUTED TO THE ENDOLEAK. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Aneurysm expansion; Clinical Endoleak; Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17285642 ↗
• InjuryApr 7, 2023Patient-Device Incompatibility; Migration; Patient-Device Incompatibility; Migration

  DEVICE MIGRATION WAS ALSO REPORTED.

  Patient problems: Pain; Ruptured Aneurysm

  MAUDE report 16704675 ↗
• InjuryOct 5, 2020Microbial Contamination of Device; Adverse Event Without Identified Device or Use Problem; Microbial Contamination of Device; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2013 A PATIENT WAS UNDERGOING TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM WITH GORE® EXCLUDER® AAA ENDOPROSTHESES. ON (B)(6) 2018 THE PATIENT REPORTEDLY HAD A RIGHT GROIN PSEUDOANEURYSM WITH INFECTED PTFE GRAFTS. ON (B)(6) 2018 THE PATIENT UNDERWENT EXTERNAL ILIAC TO MID PTFE GRAFT BYPASS; TRIPLE LIGATION OF FEMORAL VESSELS AND CLOSURE OF THE PSEUDOANEURYSM. REPORTED SEPARATELY SEE PSTS EVENT# (B)(4) MEDWATCH#3007284313-2019-00095 ON JANUARY 21, 2020 ANOTHER PSEUDOANEURYSM WAS REPORTED, OCCURRING IN THE RIGHT GROIN TREATMENT ZONE. THIS WAS TREATED BY MEANS OF A GORE® VIABAHN® ENDOPROSTHESIS 8MM X 100MM. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Pseudoaneurysm

  MAUDE report 10631563 ↗
• InjuryApr 8, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2013 A PATIENT WAS UNDERGOING TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM WITH GORE® EXCLUDER® AAA ENDOPROSTHESES. ON (B)(6) 2017 THE PATIENT HAD A DEEP STERNAL WOUND INFECTION. ON (B)(6) 2017 THE PATIENT WAS TREATED WITH IV ANTIBIOTICS, STERNAL WOUND DEBRIDEMENT AND BILATERAL PECTORALIS MAJOR MUSCLE FLAP RECONSTRUCTION. ON (B)(6) 2018 THE PATIENT REPORTEDLY HAD A RIGHT GROIN PSEUDOANEURYSM WITH INFECTED PTFE GRAFTS. ON (B)(6) 2018 THE PATIENT UNDERWENT EXTERNAL ILIAC TO MID PTFE GRAFT BYPASS; TRIPLE LIGATION OF FEMORAL VESSELS AND CLOSURE OF THE PSEUDOANEURYSM. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Unspecified Infection

  MAUDE report 8492761 ↗
• InjuryFeb 26, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2015, THE PATIENT WAS IMPLANTED WITH A GORE® EXCLUDER® AAA ENDOPROSTHESES TO TREAT AN ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT PATIENT HAD A PERSISTENT TYPE I ENDOLEAK. THERE WAS ANEURYSM ENLARGEMENT (AMOUNT IS UNKNOWN). THE PHYSICIAN REINTERVENED ON (B)(6) 2019, USED APTUS ANCHORS AND IMPLANTED A GORE® EXCLUDER® AAA AORTIC EXTENDER ENDOPROSTHESIS (B)(4). THE ENDOLEAK WAS NOT RESOLVED AND THE PHYSICIAN IS TAKING A WAIT AND WATCH APPROACH. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Aneurysm

  MAUDE report 8371480 ↗
• InjuryJan 15, 2019Patient-Device Incompatibility; Patient-Device Incompatibility

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2014, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR UNCOMPLICATED ABDOMINAL AORTIC ANEURYSM AND WAS THEREFORE TREATED WITH GORE® EXCLUDER® AAA ENDOPROSTHESES. ON AN UNKNOWN DATE IN MARCH 2016, FOLLOW-UP IMAGING REVEALED A TYPE II ENDOLEAK. ON AN UNKNOWN DATE IN 2017, FOLLOW-UP IMAGING IDENTIFIED AN ANEURYSM ENLARGEMENT WITH A DIAMETER MEASURING 54X44 MM. REPORTEDLY, THE AMOUNT OF THE ANEURYSM INCREASE WAS UNKNOWN. ON (B)(6) 2018, THE ENDOPROTHESIS WERE EXPLANTED DUE TO THE TYPE II ENDOLEAK.

  Patient problems: No Code Available

  MAUDE report 8247563 ↗

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