GORE EXCLUDER AAA Endoprosthesis with C3 Delivery RMT281412Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00733132610709), received between Aug 4, 2020 and Apr 25, 2022 — classified as 3 injuries.

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

• InjuryApr 25, 2022Patient Device Interaction Problem; Patient Device Interaction Problem

  ON (B)(6) 2013, THE PATIENT WAS TREATED FOR AN ABDOMINAL AORTIC ANEURYSM. THE PHYSICIAN IMPLANTED A GORE® EXCLUDER® AAA ENDOPROSTHESIS FEATURING C3® DELIVERY SYSTEM AND TWO GORE® EXCLUDER® AAA ENDOPROSTHESES. THE PATIENT TOLERATED THE PROCEDURE. THE PATIENT HAD COILS AND OYNX TO TREAT A TYPE 2 ENDOLEAK OVER THE LAST 6 YEARS. THE ANEURYSM SAC HAS CONTINUED TO GROW DURING THAT TIME AND IS NOW 11CM. NECK WAS 3CM AT TIME OF IMPLANT AND IS NOW LESS THAN 10MM. NO VISIBLE ENDOLEAKS WERE FOUND ON ANGIO SO THE SURGEON IS GOING TO DO AN EXPLANT IN ABOUT A MONTH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14193831 ↗
• InjuryJan 4, 2021Patient-Device Incompatibility; Patient-Device Incompatibility

  ON (B)(6) 2012, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESIS. IT WAS REPORTED THAT THE PATIENT HAD AN EXTREMELY ANGULATED PROXIMAL NECK. ON (B)(6) 2020, THE PATIENT PRESENTED WITH PROXIMAL TYPE I ENDOLEAK DUE TO THE EXTREMELY ANGULATED NECK. ANEURYSM ENLARGEMENT WAS ALSO PRESENT, ALTHOUGH EXACT AMOUNT OF ENLARGEMENT WAS NOT PROVIDED. ON THE SAME DAY A REINTERVENTION WAS PERFORMED BY IMPLANTING TWO GORE® EXCLUDER® AAA ENDOPROSTHESIS AORTIC EXTENDER COMPONENTS. THE ENDOLEAK WAS RESOLVED AND THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Aneurysm

  MAUDE report 11108535 ↗
• InjuryAug 4, 2020Adverse 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) 2014, WITH A 51 MM ABDOMINAL AORTIC ANEURYSM THAT WAS TREATED WITH GORE® EXCLUDER® AAA ENDOPROSTHESES. FOLLOW-UP IMAGING SHOWED THAT THE ANEURYSM SIZE APPEARED TO BE STABLE UNTIL MINOR ANEURYSM GROWTH WAS VISIBLE ON (B)(6) 2016 (52 MM). ON (B)(6) 2017, A TYPE II ENDOLEAK ORIGINATING FROM THE INFERIOR MESENTERIC ARTERY WAS IDENTIFIED AND UNSUCCESSFULLY TREATED WITH EMBOLIZATION ON AN UNKNOWN DATE. ANEURYSM GROWTH TO 60 MM WAS VISIBLE ON (B)(6) 2017. ON (B)(6) 2019, THE ENDOLEAK WAS TREATED WITH THE IMPLANTATION OF AN ADDITIONAL AORTIC ENDOGRAFT. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Aneurysm

  MAUDE report 10360825 ↗

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