GORE EXCLUDER AAA Endoprosthesis with C3 Delivery RMT281418Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00733132610730), received between Dec 18, 2018 and May 13, 2026 — classified as 9 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryMay 13, 2026Migration

  ON (B)(6) 2013, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF FOR AN UNKNOWN ETIOLOGY AND WAS IMPLANTED WITH GORE® EXCLUDER® AAA ENDOPROSTHESIS DEVICES. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2026, THE PATIENT UNDERWENT COMPUTED TOMOGRAPHY WHICH DETERMINED DISTAL MIGRATION OF THE DEVICES (DISTANCE UNKNOWN). ON (B)(6) 2026 THE PATIENT UNDERSENT REINTERVENTION AND TWO GORE® EXCLUDER® CONFORMABLE AORTIC EXTENDER DEVICES AND A GORE® EXCLUDER® AAA ENDOPROSTHESIS WERE IMPLANTED ALONG WITH ENDO ANCHORS TO RESTORE COVERAGE UP TO THE RENAL ARTERIES. THE DEVICE MIGRATION IS ATTRIBUTED TO DISEASE PROGRESSION AND THROMBUS IDENTIED BY THE IMAGES PROVIDED. THE PATIENT TOLERATED THE PROCEDURE WITH GOOD RESULTS.

  Patient problems: Aneurysm

  MAUDE report 25165299 ↗
• InjuryFeb 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2013, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT USING GORE® EXCLUDER® AAA ENDOPROSTHESES TO TREAT AN ABDOMINAL AORTIC ANEURYSM. PRE-TREATMENT CTA REVEALED THAT THE MAXIMUM DIAMETER OF THE AORTIC ANEURYSM/LESION WAS 71MM. THE PATIENT TOLERATED THE INITIAL PROCEDURE. REPORTEDLY, FROM (B)(6) 2013 TO (B)(6) 2019, THE MAXIMUM DIAMETER OF AORTIC ANEURYSM/LESION DECREASED IN SIZE FROM 70MM TO 63MM. FROM (B)(6) 2020 TO (B)(6) 2023, THE MAXIMUM DIAMETER OF AORTIC ANEURYSM/LESION INCREASED IN SIZE FROM 66MM TO 74MM. IT WAS REPORTED THAT ON (B)(6) 2020, A TYPE II ENDOLEAK WAS IDENTIFIED. ACCORDING TO THE PHYSICIAN, THE TYPE II ENDOLEAK CAUSED THE ANEURYSM ENLARGEMENT. ON (B)(6) 2020, THE PATIENT UNDERWENT THE TRANSLUMBER TYPE II ENDOLEAK REPAIR WITH GLUE. THE ENDOLEAK WAS FIXED. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Aneurysm expansion; Clinical Endoleak

  MAUDE report 18794339 ↗
• InjuryMay 25, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6), 2014, THE PATIENT PRESENTED WITH A 52.6 MM ABDOMINAL AORTIC ANEURYSM THAT WAS TREATED WITH GORE® EXCLUDER® AAA ENDOPROSTHESES. IT WAS REPORTED THAT BETWEEN (B)(6), 2022, AND (B)(6), 2023, COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) REVEALED ANEURYSM GROWTH FROM 70 MM TO 78 MM. IN ADDITION, A TYPE II ENDOLEAK FEEDING THE ANEURYSMAL SAC AT THE RIGHT ILIAC LEG OF THE ENDOPROSTHESIS WAS DETECTED ON (B)(6) 2023. ON (B)(6), 2023, AN EMBOLIZATION WITH 1.5 CC OF SQUIDPERI (PLUSMEDICA) WAS PERFORMED TO RESOLVE THE TYPE II ENDOLEAK. AN AORTOGRAM SHOWED THAT THE ENDOLEAK ORIGINATED FROM THE RIGHT LATERAL SACRAL BRANCHES WHICH WERE FILLED THROUGH THE LEFT HYPOGASTRIC POSTERIOR DIVISION-LEFT LATERAL SACRAL-MIDDLE SACRAL-RIGHT LATERAL SACRAL CIRCUIT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE PATIENT TOLERATED THE PROCEDURE. REPORTEDLY, A CTA PERFORMED ON (B)(6) 2023, SHOWED PERSISTENT TYPE II ENDOLEAKAGE. THE ANEURYSMAL SAC MEASURED 79 MM. NO FURTHER REINTERVENTION WAS REPORTED.

  Patient problems: Aneurysm expansion; Clinical Endoleak

  MAUDE report 17002024 ↗
• InjuryFeb 24, 2023Positioning Failure; Positioning Failure

  ON (B)(6) 2011, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM AND WAS IMPLANTED WITH GORE® EXCLUDER® AAA ENDOPROSTHESES. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2023, THE PATIENT UNDERWENT REINTERVENTION TO TREAT SUSPECTED MIGRATION OF THE PROXIMAL TRUNK, AS IMAGING SHOWED PLACEMENT TO BE 4CM DISTAL TO THE LOWEST RENAL ARTERY; ADDITIONALLY, THE PHYSICIAN REPORTS SOME EROSION OR DEGRADATION OF THE SUPERIOR AORTIC NECK. THE AMOUNT OF MIGRATION WAS NOT KNOWN AS THE PHYSICIAN DID NOT KNOW WHERE THE TRUNK HAD BEEN ORIGINALLY LANDED. TWO GORE® EXCLUDER® AORTIC EXTENDERS WERE IMPLANTED TO EXTEND COVERAGE BACK UP TO THE RENAL ARTERIES. THE PHYSICIAN REPORTS NO ENDOLEAK WAS SEEN AND THERE DID NOT APPEAR TO BE ANY ENLARGEMENT OF THE ANEURYSM IN HIS OPINION. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Aneurysm

  MAUDE report 16439318 ↗
• InjuryJul 20, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED THAT A PATIENT PRESENTING WITH ABDOMINAL AORTIC ANEURYSM WAS TREATED WITH A GORE® EXCLUDER® AAA ENDOPROSTHESIS ON (B)(6) 2012. ON (B)(6) 2017, THE PATIENT WAS TREATED FOR A TYPE IA ENDOLEAK WITH AN ADDITIONAL STENT GRAFT. AFTER IMPLANTATION, THE ANEURYSM REPORTEDLY DECREASED TO 61 MM WHEN MEASURED WITH ULTRASOUND ON (B)(6) 2017. NEW ANEURYSM GROWTH TO 65 MM WAS DETECTED ON (B)(6) 2017. THE ANEURYSM INCREASED TO ITS MAXIMUM DIAMETER OF 80 MM ON (B)(6) 2022. THE CAUSE OF THE ANEURYSM GROWTH IS UNKNOWN.

  Patient problems: Aneurysm

  MAUDE report 15063967 ↗
• InjuryJul 19, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED THAT A PATIENT PRESENTED WITH ABDOMINAL AORTIC ANEURYSM (PRE-IMPLANT CTA MAXIMUM AORTIC DIAMETER 74 MM) AND WAS TREATED WITH A GORE® EXCLUDER® AAA ENDOPROSTHESIS ON (B)(6) 2012. AFTER DECREASING TO 55 MM (CTA IMAGING) FROM ITS INITIAL MAXIMUM DIAMETER ON (B)(6) 2014, ANEURYSM GROWTH OF 10 MM WAS DETECTED ON (B)(6) 2014. ON (B)(6) 2016, A TYPE IA ENDOLEAK WAS DETECTED. ON (B)(6) 2017, AN ADDITIONAL STENT GRAFT WAS IMPLANTED TO SUCCESSFULLY TREAT THE TYPE IA ENDOLEAK. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Aneurysm

  MAUDE report 15052143 ↗
• InjuryMay 13, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2014, THE PATIENT PRESENTED WITH A 52.6 MM ABDOMINAL AORTIC ANEURYSM THAT WAS TREATED WITH GORE® EXCLUDER® AAA ENDOPROSTHESES. FOLLOW-UP IMAGING SHOWED THAT THE ANEURYSM DECREASED IN SIZE FROM 48MM ON (B)(6) 2014 TO 42MM ON (B)(6) 2015. FROM (B)(6) 2016 TO (B)(6) 2020, THE MAXIMUM ANEURYSM DIAMETER INCREASED IN SIZE FROM 50MM TO 70MM. ON (B)(6) 2020, A TYPE II ENDOLEAK WAS IDENTIFIED. DUE TO THE ANEURYSM ENLARGEMENT, IT WAS DECIDED TO EMBOLIZED THE INFERIOR MESENTERIC (IMA) AND LUMBAR ARTERIES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Aneurysm

  MAUDE report 14393590 ↗
• InjuryAug 5, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6), 2011 THE PATIENT HAD TWO GORE® EXCLUDER® AAA ENDOPROSTHESES IMPLANTED TO REPAIR AN ABDOMINAL AORTIC ANEURYSM (AAA). ON (B)(6), 2016 THE PATIENT PRESENTED WITH ABDOMINAL AND LOWER BACK PAIN AFTER A FALL. IMAGING SHOWED A TYPE II ENDOLEAK FROM A LUMBAR ARTERY AND THE PHYSICIAN DECIDED TO MONITOR THE PATIENT AT THAT TIME. ON AN UNKNOWN DATE IN 2017, THE PATIENT REPORTEDLY HAD SURGERY TO REPAIR THE TYPE II ENDOLEAK (DEVICES UNKNOWN). REPORTEDLY THE ENDOLEAK WAS RESOLVED AT THIS TIME. IT WAS ALSO REPORTED THAT THE PATIENT HAD COILING OF THE ANEURYSM SAC AND THE INFERIOR MESENTERIC ARTERY (IMA) DURING THIS PROCEDURE. ON (B)(6), 2019, THE PATIENT WAS ADMITTED TO THE HOSPITAL AND THE PHYSICIAN DECIDED TO LOOK FOR A SUSPECTED ENDOLEAK. WHILE INSIDE OF THE PATIENT AND ENDOLEAK WAS NOT SEEN, BUT THE CT SCAN SHOWED SOME TYPE OF LEAK ABOVE THE RMT281418 (MAIN BODY) DEVICE. THE PATIENT REPORTED THAT A NEW ANEURYSM HAD GROWN ABOVE THE CURRENT GORE DEVICES IMPLANTED. REPORTEDLY SINCE THE PHYSICIAN WAS UNCLEAR OF THE ORIGIN OF THE LEAK, HE DECIDED TO RELINE THE PREVIOUSLY IMPLANTED GORE DEVICE WITH A NON-GORE (OVATION) DEVICE. THE OVATION DEVICE WAS THEN IMPLANTED ABOVE THE RENAL ARTERIE

  Patient problems: Aneurysm

  MAUDE report 8862267 ↗
• InjuryFeb 19, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2014, THE PATIENT UNDERWENT TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM (AAA) AND LEFT COMMON ILIAC ARTERY ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESES AND GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESES. REPORTEDLY, THE ABDOMINAL AORTA MEASURED 63.1 MM AT THE TIME OF IMPLANT. ACCORDING TO THE REPORT, FINAL ANGIOGRAPHY SHOWED EXCLUSION OF THE ANEURYSM AND NO ENDOLEAKS. THE PATIENT WAS REPORTED TO HAVE TOLERATED THE PROCEDURE. ON (B)(6) 2014, FOLLOW UP IMAGING IDENTIFIED A TYPE II ENDOLEAK WITH LUMBAR ARTERY INVOLVEMENT. THE AORTA REPORTEDLY MEASURED 63.9 MM (ORTHOGONAL). ON (B)(6) 2015, FOLLOW UP IMAGING SHOWED A PERSISTENT TYPE II ENDOLEAK WITH LUMBAR ARTERY INVOLVEMENT. THE AORTA REPORTEDLY MEASURED 60.0 MM (ORTHOGONAL). IT WAS REPORTED, THERE WAS A REINTERVENTION ON (B)(6) 2015, COIL EMBOLIZATION. THE TYPE II ENDOLEAK RESOLVED BY (B)(6) 2015. THE RIGHT INTERNAL ARTERY WAS COVERED AND COILED. MAX ABDOMINAL AORTIC DIAMETER MEASURED 56.1MM. RIGHT COMMON ILIAC ARTERY MEASURED 24.9MM. LEFT COMMON ILIAC ARTERY MEASURED 28.5MM. THE PATIENT TOLERATED THE REINTERVENTION PROCEDURE.

  Patient problems: Aneurysm

  MAUDE report 8350625 ↗
• MalfunctionDec 18, 2018Fracture; Fracture

  ON (B)(6) 2014, 6 MONTH IMAGING FOLLOW-UP IDENTIFIED A WIRE FRACTURE PROXIMAL TO THE FLOW DIVIDER OF THE TRUNK-IPSILATERAL COMPONENT.

  Patient problems: Aneurysm

  MAUDE report 8174171 ↗

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)