GORE EXCLUDER AAA Endoprosthesis with C3 Delivery RMT281214Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00733132610679), received between Jul 19, 2018 and Feb 8, 2024 — 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.

• InjuryFeb 8, 2024Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  ON (B)(6), 2013 A PATIENT UNDERWENT TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM MEASURING 59.9MM WITH GORE® EXCLUDER® AAA ENDOPROSTHESES. ON (B)(6), 2013 A CT REVEALED THE ANEURYSM MEASURED 55MM. FROM (B)(6), 2014 TO (B)(6), 2018 A FOLLOW UP CT REVEALED THE MAXIMUM DIAMETER OF AORTIC ANEURYSM/LESION INCREASED IN SIZE FROM 57MM TO 69.7MM. ON (B)(6), 2014 A POSSIBLE TYPE II ENDOLEAK FROM LUMBAR ARTERIES WAS DETERMINED. ON (B)(6), 2018, A PERSISTENT TYPE II ENDOLEAK WAS CONFIRMED. ON (B)(6), 2018, THE PATIENT UNDERWENT ANGIOEMBOLISM OF A TYPE II ENDOLEAK. THE ANGIOEMBOLISM WAS UNSUCCESSFUL. ON (B)(6) 2018, THE PATIENT UNDERWENT PERCUTANEOUS EMBOLIZATION OF THE ENDOLEAK. ON (B)(6), 2019, A CT REVEALED THE ANEURYSM MEASURED 71MM. THE EVENT WAS ONGOING. (THIS WAS COVERED BY THE EVENT# (B)(4), PSTS). FROM OCTOBER 23, 2019 TO OCTOBER 6, 2023 THE MAXIMUM DIAMETER OF AORTIC ANEURYSM/LESION INCREASED IN SIZE FROM 73MM TO 100MM. ON (B)(6), 2023, THE PATIENT PRESENTED WITH THE ABDOMINAL PAIN. THE TYPE I AND A PERSISTENT TYPE II ENDOLEAKS WERE DETERMINED. AS PATIENT HAD CHANGED VASCULAR SURGEONS, IT WAS UNABLE TO HAVE ACCESS TO PATIENT¿S FOLLOW UP. FROM THE DISCHARGE SUMMARY IT STATES THAT PATIENT

  Patient problems: Aneurysm expansion; Clinical Endoleak

  MAUDE report 18665415 ↗
• InjuryJul 23, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2015, THIS PATIENT UNDERWENT AN ENDOVASCULAR REPAIR OF AN ABDOMINAL AORTIC ANEURYSM USING A GORE® EXCLUDER® AAA ENDOPROSTHESIS. NO ISSUES WERE REPORTED. THE PATIENT TOLERATED THE PROCEDURE. POST-OPERATIVELY, THE ANEURYSM SHRINKAGE WAS OBSERVED. ON AN UNKNOWN DATE, FOLLOW-UP IMAGING IDENTIFIED A PROXIMAL TYPE I ENDOLEAK WITH THE ANEURYSM ENLARGEMENT (AMOUNT UNKNOWN). THE CAUSE OF THE ENDOLEAK WAS REPORTED TO BE UNKNOWN. ON (B)(6) 2019, AN ADDITIONAL DEVICE WAS IMPLANTED TO EXTEND THE PROXIMAL NECK TO REPAIR THE ENDOLEAK. ADDITIONALLY COIL EMBOLIZATION TO THE LUMBER ARTERIES AND THE ANEURYSM SAC WAS PERFORMED. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Aneurysm

  MAUDE report 8817810 ↗
• InjuryMar 27, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2013 A PATIENT UNDERWENT TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM MEASURING 59.9MM WITH GORE® EXCLUDER® AAA ENDOPROSTHESES. ON (B)(6) 2013 A CT REVEALED THE ANEURYSM MEASURED 55MM. ON (B)(6) 2014 A CT REVEALED THE ANEURYSM MEASURED 57MM. ON (B)(6) 2017 A CT REVEALED THE ANEURYSM MEASURED 56MM. ON (B)(6) 2018 A CT REVEALED THE ANEURYSM MEASURED 69.7MM. ON (B)(6) 2018 THE PATIENT UNDERWENT ANGIOEMBOLISM OF A TYPE II ENDOLEAK. THE ANGIOEMBOLISM WAS UNSUCCESSFUL. ON (B)(6) 2018 THE PATIENT UNDERWENT PERCUTANEOUS EMBOLIZATION OF THE ENDOLEAK. ON (B)(6) 2019 A CT REVEALED THE ANEURYSM MEASURED 71MM. THE EVENT IS ONGOING.

  Patient problems: Aneurysm

  MAUDE report 8458432 ↗
• InjuryJul 19, 2018Patient-Device Incompatibility; Patient-Device Incompatibility

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2013, THE PATIENT PRESENTED WITH AN ABDOMINAL AORTIC ANEURYSM THAT WAS TREATED WITH THE IMPLANTATION OF GORE® EXCLUDER® AAA ENDOPROSTHESES. ON (B)(6) 2013, POST-OPERATIVE IMAGING SHOWED AN ANEURYSM DIAMETER OF 86MM THAT REPORTEDLY DECREASED TO 81MM DURING FOLLOW-UP IMAGING ON (B)(6) 2016. ON (B)(6) 2017, A CONTROL ANGIOGRAM SHOWED ANEURYSM ENLARGEMENT TO 83MM WITHOUT EVIDENCE OF AN ENDOLEAK. ON (B)(6) 2018, ADDITIONAL ANEURYSM ENLARGEMENT TO 85MM AND A PROXIMAL TYPE I ENDOLEAK WERE REPORTED ON A CONTROL ANGIOGRAM. IT WAS STATED THAT THE ENDOLEAK WILL BE TREATED WITH THE IMPLANTATION OF AN AORTIC EXTENDER ENDOPROSTHESIS ON (B)(6) 2018. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: No Code Available

  MAUDE report 7701598 ↗

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)