GORE EXCLUDER AAA Endoprosthesis with C3 Delivery RMT231418Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00733132610570), received between Aug 7, 2018 and Nov 23, 2021 — classified as 4 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryNov 23, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT (B)(6) 2014, THE PATIENT PRESENTED WITH AN ABDOMINAL AORTIC ANEURYSM THAT WAS TREATED WITH GORE® EXCLUDER® AAA ENDOPROSTHESIS (PRE-IMPLANT CT DIAMETER 47 MM). ON (B)(6) 2015 A TYPE II ENDOLEAK WAS IDENTIFIED (CT DIAMETER 47 MM). ON (B)(6) 2021, THE ENDOLEAK WAS TREATED WITH CT GUIDED PERCUTANEOUS EMBOLIZATION ((B)(6)2021 CT DIAMETER: 51 MM). THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Aneurysm

  MAUDE report 12859269 ↗
• InjuryApr 13, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2013, THE PATIENT WAS IMPLANTED WITH A GORE® EXCLUDER® AAA ENDOPROSTHESES TO TREAT AN ABDOMINAL AORTIC ANEURYSM. ON AN UNKNOWN DATE, A FOLLOW-UP COMPUTED TOMOGRAPHY SCAN REPORTEDLY REVEALED A TYPE II ENDOLEAK WITH ANEURYSM SAC ENLARGEMENT. ON (B)(6) 2020, THERE WAS A REINTERVENTION AND THE PHYSICIAN COILED SEVERAL ACCESSORY ARTERIES THEN IMPLANTED A GORE® EXCLUDER® AAA CONTRALATERAL LEG ENDOPROSTHESIS IN THE RIGHT COMMON ILIAC ARTERY TO EXTEND THE ALREADY IMPLANTED DEVICE. THE PATIENT TOLERATED THE REINTERVENTION PROCEDURE.

  Patient problems: Aneurysm

  MAUDE report 9954730 ↗
• InjuryNov 5, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  ON (B)(6) 2013, THE PATIENT WAS IMPLANTED WITH A GORE® EXCLUDER® AAA ENDOPROSTHESIS TO TREAT AN ABDOMINAL AORTIC ANEURYSM. ON (B)(6) 2017, A FOLLOW-UP COMPUTED TOMOGRAPHY (CT) SCAN REPORTEDLY REVEALED A SUSPECTED PROXIMAL TYPE I ENDOLEAK. ON (B)(6) 2018, A FOLLOW-UP CT SCAN REPORTED SHOWED THE SAME SUSPECTED TYPE I ENDOLEAK CONTRIBUTING TO ANEURYSM ENLARGEMENT. ON (B)(6) 2018, THE PATIENT UNDERWENT A RE-INTERVENTION PROCEDURE WHEREBY AN EXCLUDER® AORTIC EXTENDER COMPONENT WAS IMPLANTED TO TREAT THE TYPE I ENDOLEAK. AN INTRA-OPERATIVE ANGIOGRAM REPORTEDLY SHOWED THE ENDOLEAK WAS NOT COMPLETELY RESOLVED. THE PHYSICIAN THEN IMPLANTED A PALMAZ STENT PROXIMALLY, AND THE ENDOLEAK WAS RESOLVED. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8038833 ↗
• InjuryAug 7, 2018Obstruction of Flow; Obstruction of Flow

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2012, THE PATIENT PRESENTED WITH AN ABDOMINAL AORTIC ANEURYSM THAT WAS TREATED WITH THE IMPLANTATION OF GORE® EXCLUDER® AAA ENDOPROSTHESES. ON (B)(6) 2018, FOLLOW-UP CT AND ULTRASOUND IMAGING SHOWED DEVICE OCCLUSION OF THE RIGHT LEG OF THE GORE® EXCLUDER® AAA ENDOPROSTHESES. IT WAS STATED THAT THE OCCLUSION WAS SUCCESSFULLY TREATED WITH THE IMPLANTATION OF AN ADDITIONAL DEVICE ON (B)(6) 2018.

  Patient problems: Occlusion

  MAUDE report 7756046 ↗

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