GORE EXCLUDER AAA Endoprosthesis with C3 Delivery RMT311413Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00733132610747), received between Aug 13, 2018 and Feb 3, 2022 — classified as 5 injuries.

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.

• InjuryFeb 3, 2022Migration or Expulsion of Device; Migration or Expulsion of Device

  ON (B)(6) 2012, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM AND WAS IMPLANTED WITH GORE® EXCLUDER® AAA ENDOPROSTHESES FEATURING C3® DELIVERY SYSTEM. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2022, THE PATIENT PRESENTED WITH A RUPTURED ABDOMINAL AORTIC ANEURYSM AND APPROXIMATELY 7 CM DISTAL MIGRATION OF THE TRUNK IPSILATERAL LEG COMPONENT BACK INTO THE ANEURYSM SAC. A REINTERVENTION WAS PERFORMED WHEREIN 3 CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESES AND A GORE® AORTIC EXTENDER COMPONENT WERE IMPLANTED TO RESTORE COVERAGE BACK UP TO THE LOWEST RENAL ARTERY AND TREATMENT OF THE RUPTURE. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Aneurysm

  MAUDE report 13444809 ↗
• InjuryOct 6, 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) 2013, WITH AN ABDOMINAL AORTIC ANEURYSM THAT WAS TREATED WITH THE IMPLANTATION OF GORE® EXCLUDER® AAA ENDOPROSTHESES. ON (B)(6) 2019, THE ENDOPROSTHESIS WAS EXPLANTED DUE TO ANEURYSM RUPTURE. IT WAS STATED THAT THE RUPTURE WAS PROBABLY CAUSED BY AN AORTO-CAVE FISTULA THAT APPEARED TO BE VISIBLE ON PRE-EXPLANT IMAGES DATED (B)(6) 2019. AN AORTO-BI-FEMORAL BYPASS WAS PERFORMED. THE PATIENT STATE HAS DETERIORATED, PALLIATIVE CARE WAS DECIDED. THE PATIENT EXPIRED ON (B)(6) 2019.

  Patient problems: Aneurysm

  MAUDE report 10635049 ↗
• InjuryJan 24, 2019Patient-Device Incompatibility; Patient-Device Incompatibility

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2010, THE PATIENT PRESENTED WITH AN ABDOMINAL AORTIC ANEURYSM THAT WAS TREATED WITH THE IMPLANTATION OF GORE® EXCLUDER® AAA ENDOPROSTHESES IN AN ANGULATED NECK (>60°). ON (B)(6) 2018, A PROXIMAL TYPE I ENDOLEAK WAS IDENTIFIED AND UNSUCCESSFULLY TREATED WITH ENDOVASCULAR REFIXATION ON (B)(6) 2018. IT WAS STATED THAT THE POSTOP CT SHOWED A PERSISTENT ENDOLEAK. THE PATIENT DENIED THE OFFERED SURGICAL TREATMENT.

  Patient problems: No Code Available

  MAUDE report 8273439 ↗
• InjuryDec 14, 2018Patient-Device Incompatibility; Patient-Device Incompatibility

  ON (B)(6) 2012, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM MEASURING 58 MM IN DIAMETER AND WAS THEREFORE TREATED WITH GORE® EXCLUDER® AAA ENDOPROSTHESES.

  Patient problems: No Code Available

  MAUDE report 8164538 ↗
• InjuryAug 13, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2012, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM AND WAS IMPLANTED WITH GORE® EXCLUDER® AAA ENDOPROSTHESIS FEATURING C3® DELIVERY SYSTEM. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2017, FOLLOW-UP IMAGING DETERMINED AN ENDOLEAK, THE ANEURYSM DIAMETER WAS REPORTED TO MEASURE 6.8 CM. IT WAS UNABLE TO DETERMINE IF THE ENDOLEAK WAS A PROXIMAL TYPE I OR A TYPE II ENDOLEAK. ON (B)(6) 2018, FOLLOW-UP IMAGING DETERMINED AN ENDOLEAK PERSISTED; THE ANEURYSM DIAMETER WAS REPORTED TO MEASURE 7.3 CM. IT WAS UNABLE TO DETERMINE IF THE ENDOLEAK WAS A PROXIMAL TYPE I OR A TYPE II ENDOLEAK. ON (B)(6) 2018, THE PATIENT UNDERWENT REINTERVENTION. THREE ANGIOGRAM'S WERE PERFORMED ON THE PATIENT HOWEVER THE TYPE AND SOURCE WAS INCONCLUSIVE. A GORE® EXCLUDER® AORTIC EXTENDER COMPONENT WAS PLACED PROXIMALLY TO EXTEND COVERAGE. FINAL ANGIOGRAPHY WAS UNABLE TO DETERMINED IF THE ENDOLEAK WAS RESOLVED. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Aneurysm

  MAUDE report 7777849 ↗

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