GORE EXCLUDER AAA Endoprosthesis with C3 Delivery RMT231416Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00733132610563), received between Aug 6, 2020 and Sep 5, 2024 — classified as 1 death, 4 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.

• InjurySep 5, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2011, A PATIENT WAS TREATED USING GORE® EXCLUDER® AAA ENDOPROSTHESES. AT THAT TIME, THE ANEURYSMAL SAC REPORTEDLY MEASURED ABOUT 6CM ACCORDING TO THE PATIENT. ON AN UNKNOWN DATE IN 2018, A CT SCAN WAS TAKEN MEASURING THE ANEURYSMAL SAC AT 7.8CM WITH A TYPE TWO ENDOLEAK. ON (B)(6) 2024, AN ENDOLEAK WAS DETECTED ON A CT SCAN. THE PHYSICIAN SUSPECTED THIS TO BE A TYPE II ENDOLEAK FROM THE LUMBAR ARTERY. THE PHYSICIAN ALSO NOTED DILATION PROXIMALLY, LEADING TO A LACK OF DEVICE APPOSITION. ON (B)(6) 2024, A REINTERVENTION OCCURS TO TREAT THE SUSPECTED ENDOLEAK. THE LUMBAR ARTERY WAS COIL EMBOLIZED, AND AN AORTIC EXTENDER WAS PLACED PROXIMALLY IN THE INFRARENAL NECK. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Clinical Endoleak

  MAUDE report 20148048 ↗
• DeathMar 5, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE THROUGH THE GLOBAL REGISTRY FOR ENDOVASCULAR AORTIC TREATMENT (GREAT 10-11): ON (B)(6) 2012, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM WITH GORE® EXCLUDER® AAA ENDOPROSTHESES. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2016, THE PATIENT UNDERWENT REINTERVENTION FOR A REPORTED PROXIMAL TYPE I ENDOLEAK THOUGHT TO HAVE BEEN CONTRIBUTED TO BY DEVICE MIGRATION. THE ANEURYSM DIAMETER WAS REPORTED TO MEASURE 70MM. A GORE® EXCLUDER® AORTIC EXTENDER COMPONENT (PLA230300/ 14508294) WAS PLACED JUST DISTAL TO THE RENAL ARTERIES TO EXTEND COVERAGE OF THE TRUNK IPSILATERAL LEG COMPONENT. THE PATIENT TOLERATED THE PROCEDURE AND THE ENDOLEAK WAS REPORTED TO HAVE BEEN RESOLVED. NO COMPLICATIONS WERE REPORTED AND THE PATIENT WAS DISCHARGED ON (B)(6) 2016. REPORTEDLY, THE ANEURYSM EXPANDED BY 1.5 CM SINCE ON (B)(6) 2016. (COVERED BY THE EVENT#: (B)(4), PSTS). IT WAS REPORTED THAT ON (B)(6) 2017, A TYPE II ENDOLEAK FROM LUMBER ARTERIES AND A DISTAL TYPE I ENDOLEAK FROM THE RIGHT COMMON ILIAC ARTERY WERE IDENTIFIED. IT WAS UNKNOWN WHAT CAUSED A DISTAL TYPE I ENDOLEAK. ON (B)(6) 2017, THE PATIENT UNDERWENT THE COIL E

  Patient problems: Aneurysm expansion; Insufficient Information

  MAUDE report 18843012 ↗
• InjuryDec 13, 2023Patient-Device Incompatibility; Migration; Patient-Device Incompatibility; Migration

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2012, PATIENT UNDERWENT AN UNKNOWN ENDOVASCULAR PROCEDURE UTILIZING A GORE® EXCLUDER® AAA ENDOPROSTHESIS (TRUNK IPSILATERAL LEG C3 AND ILIAC EXTENDER). ON (B)(6) 2023, THE FIELD SALES ASSOCIATE (FSA) WAS INFORMED BY THE PHYSICIAN THAT THERE IS A PATIENT WHO HAS A TYPE 1A ENDOLEAK AS THE TRUNK IPSILATERAL STENT GRAFT APPEARS TO BE ABOUT 22MM FROM THE RENAL ARTERIES. IN ADDITION, THE CT SCAN SHOWED THAT THE PATIENT HAS CONTRAST OUTSIDE THE LEFT LIMB (CONTRAST LEAKING OUT OF THE GRAFT), WHICH IS THE ILIAC EXTENDER AS THE ILIAC ARTERY HAS EXPANDED AROUND THE LIMB, HOWEVER IT DOES NOT APPEAR TO BE FILLING THE SAC. THE PHYSICIAN PLANS TO PUT AN AORTIC EXTENDER (CUFF) IN AND LAND UP TO THE RENALS BY EXTENDING PROXIMALLY FROM THE TRUNK IPSILATERAL STENT GRAFT. PATIENT IS GOING TO BE MONITORED. PHYSICIAN BELIEVES THE ENDOLEAK OCCURRED BECAUSE THE GRAFT IS 22MM DOWN FROM THE RENAL ARTERIES AND A REINTERVENTION WILL BE NEEDED BUT NO DATE FOR REINTERVENTION HAS BEEN DECIDED.

  Patient problems: Aneurysm expansion; Clinical Endoleak

  MAUDE report 18322721 ↗
• InjuryMar 27, 2023Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  ON (B)(6) 2014, THE PATIENT WAS IMPLANTED WITH GORE® EXCLUDER® AAA ENDOPROSTHESES TO TREAT AN ABDOMINAL AORTIC ANEURYSM. REPORTEDLY, PRE-TREATMENT COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) SHOWED THAT THE MAXIMUM DIAMETER OF THE AORTIC ANEURYSM/LESION WAS 62.2.MM. PATIENT TOLERATED THE PROCEDURE. FROM (B)(6) 2014 TO (B)(6) 2014 THE FOLLOW UP SCANS DETERMINED THAT THE MAXIMUM DIAMETER OF THE AORTIC ANEURYSM/LESION INCREASED IN SIZE FROM 62MM TO 67.6MM. FROM (B)(6) 2015 TO (B)(6) 2018 THE FOLLOW UP SCANS DETERMINED THAT THE MAXIMUM DIAMETER OF THE AORTIC ANEURYSM/LESION DECREASED IN SIZE FROM 65.2MM TO 56MM. FROM (B)(6) 2019 TO (B)(6) 2021 THE FOLLOW UP SCANS DETERMINED THAT THE MAXIMUM DIAMETER OF THE AORTIC ANEURYSM/LESION INCREASED IN SIZE FROM 57MM TO 60MM. REPORTEDLY, ON (B)(6) 2022, AN INFRARENAL ABDOMINAL AORTIC ANEURYSM ENLARGEMENT WITH RIGHT AND LEFT ILIAC DISTAL TYPE I ENDOLEAKS WERE NOTICED. REPORTEDLY, ON (B)(6) 2023, THE PATIENT HAD A RIGHT AND A LEFT ILIOFEMORAL ANGIOGRAM PROCEDURE WITH A DISTAL LIMB EXTENSION ON THE RIGHT SIDE USING A PLC231000/25278865 DEVICE AND ON THE LEFT SIDE USING A PLC271200/24923176 DEVICE. THE DEVICES WERE POST DILATED USING A RELIANT ANGIOPLASTY

  Patient problems: Aneurysm; Clinical Endoleak

  MAUDE report 16625250 ↗
• InjuryAug 6, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2014, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESIS FEATURING C3 DEPLOYMENT SYSTEM. ON (B)(6) 2020 A REINTERVENTION WAS PERFORMED FOR A SUSPECTED, BUT UNSUBSTANTIATED PROXIMAL TYPE I ENDOLEAK. AN AORTIC EXTENDER COMPONENT WAS IMPLANTED. THE PATIENT IS DOING WELL AND TOLERATED THE PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10375953 ↗

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