GORE EXCLUDER AAA Endoprosthesis with C3 Delivery RLT281212Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00733132622481), received between Aug 27, 2018 and Mar 5, 2025 — classified as 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryMar 5, 2025Migration; Device Endoleak; Migration; Device Endoleak

  IT WAS REPORTED TO GORE THAT ON AN UNKNOWN DATE IN (B)(6) 2022 THIS PATIENT UNDERWENT A PROCEDURE TO TREAT AN ABDOMINAL AORTIC ANEURYSM AND WAS IMPLANTED WITH GORE® EXCLUDER® AAA ENDOPROSTHESES AND GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESES. ON AN UNKNOWN DATE, FOLLOW-UP IMAGING REPORTEDLY SHOWED DISTAL MIGRATION OF THE IPSILATERAL TRUNK RESULTING IN AN ENDOLEAK AND SAC ENLARGEMENT. THE EXACT ANEURYSM SAC GROWTH IS UNKNOWN. THE PHYSICIAN REPORTEDLY BELIEVES THAT THE REASON FOR THE MIGRATION IS LIKELY DISEASE PROGRESSION. THE PHYSICIAN HAS PLANNED A REINTERVENTION FOR DEVICE EXPLANT. THERE IS NO EXPLANT DATE AS OF YET.

  Patient problems: Aneurysm expansion; Clinical Endoleak

  MAUDE report 21523710 ↗
• InjuryApr 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FIELD SALES ASSOCIATE (FSA) REPORTED THE FOLLOWING: ON (B)(6) 2024, 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 ON (B)(6) 2024, THE PATIENT HAD A REINTERVENTION TO TREAT A PROXIMAL TYPE I ENDOLEAK. REPORTEDLY THE PATIENT HAS A CALCIFIED AORTA, AND THIS WAS CAUSING THE ENDOLEAK. THE PHYSICIAN USED THIRTEEN ENDOANCHORS, THE ENDOLEAK WAS RESOLVED. THERE WAS NO ANEURYSM SAC ENLARGEMENT. THE PATIENT TOLERATED THE REINTERVENTION.

  Patient problems: Clinical Endoleak

  MAUDE report 19149022 ↗
• InjuryMay 23, 2023Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2016, A PATIENT PRESENTING WITH AN ABDOMINAL AORTIC ANEURYSM WAS TREATED WITH A GORE® EXCLUDER® AAA ENDOPROSTHESIS. FOLLOWING THE INITIAL PROCEDURE, A MAXIMUM AORTIC DIAMETER OF 55 MM WAS MEASURED USING ULTRASOUND. THE MAXIMUM AORTIC DIAMETER INCREASED TO TO 62 MM AS MEASURED USING ULTRASOUND ON (B)(6) 2021. ON (B)(6) 2023, THE PATIENT PRESENTED WITH A TYPE IA ENDOLEAK AND WAS TREATED WITH THE IMPLANTATION OF AN ADDITIONAL DEVICE TO EXTEND THE ENDOPROSTHESIS PROXIMALLY.

  Patient problems: Aneurysm expansion; Clinical Endoleak

  MAUDE report 16984645 ↗
• MalfunctionAug 30, 2018Difficult or Delayed Activation; Difficult or Delayed Activation

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2018, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM AND WAS TREATED WITH GORE® EXCLUDER® AAA ENDOPROSTHESES. THE CONTRAGATE DID NOT OPEN FULLY DURING FIRST STAGE DEPLOYMENT OF A GORE® EXCLUDER® TRUNK-IPSILATERAL LEG COMPONENT RLT281212. AFTER A TIME INTENSIVE PROCESS OF CANNULATING THE CONTRAGATE DUE TO THE REDUCTION IN DIAMETER, THE CLINICIAN ADVANCED A 12 FRENCH GORE® DRY SEAL FLEX INTRODUCER SHEATH, TO WHICH THE CONTRAGATE VISIBLY 'POPPED' OPEN. REPORTEDLY, ALL PROCEDURAL STEPS WERE FOLLOWED ACCORDING TO THE INSTRUCTIONS FOR USE AND THE 18FR GORE® DRY SEAL FLEX INTRODUCER SHEATH WAS RETRACTED APPROXIMATELY 25/30MM DISTALLY FROM THE CONTRAGATE MARKER ON FIRST STAGE DEPLOYMENT. THE REASON FOR THE INITIALLY INHIBITED FULL DEPLOYMENT OF THE CONTRAGATE WAS REPORTEDLY UNKNOWN AND THERE WAS NO CALCIFICATION OR TORTUOUS ANATOMY THAT WAS THOUGHT TO HAVE CONTRIBUTED TO THIS INCIDENT. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7831748 ↗
• InjuryAug 27, 2018Patient-Device Incompatibility; Patient-Device Incompatibility

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2018, THIS PATIENT UNDERWENT EMERGENCY ENDOVASCULAR TREATMENT FOR A RUPTURED ABDOMINAL AORTIC ANEURYSM AND WAS TREATED WITH GORE® EXCLUDER® AAA ENDOPROSTHESES. ON (B)(6) 2018, FOLLOW-UP COMPUTED TOMOGRAPHY IMAGING IDENTIFIED A TYPE 1A ENDOLEAK RESULTING FROM THE PATIENT¿S AORTIC NECK LENGTH WITH 10 MM ONLY AND THEREFORE CONSIDERED OUTSIDE OF THE INSTRUCTIONS FOR USE. ON (B)(6) 2018, A RE-INTERVENTION WAS PERFORMED AND IT WAS UNSUCCESSFULLY ATTEMPTED TO REPAIR THE ENDOLEAK BY USING APTUS® STAPLES. THE SITUATION WAS SUBSEQUENTLY SOLVED BY INJECTING THROMBIN INTO THE ANEURYSM SAC. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: No Code Available

  MAUDE report 7815764 ↗

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)