GORE EXCLUDER AAA Endoprosthesis with C3 Delivery RMT261414Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00733132610631), received between Nov 15, 2018 and Jul 17, 2025 — classified as 8 injuries.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (3 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryJul 17, 2025Device Endoleak; Device Endoleak

  THE FOLLOWING WAS REPORTED TO GORE FROM IMEDIDATA DATABASE: IT WAS REPORTED TO GORE THAT ON (B)(6) 2014 THIS PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE AND WAS IMPLANTED WITH GORE® EXCLUDER® AAA ENDOPROSTHESIS DEVICES TO TREAT AN ABDOMINAL AORTIC ANEURYSM MEASURING 75 MM IN DIAMETER. ON (B)(6) 2014 COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) IMAGING FOUND THE ANEURYSM TO MEASURE 74 MM IN DIAMETER. ON (B)(6) 2014 A TYPE II ENDOLEAK ORIGINATING FROM THE INFERIOR MESENTERIC ARTERY (IMA) WAS DIAGNOSED. ON (B)(6) 2014 THE IMA WAS COIL EMBOLIZED. ON (B)(6) 2015 ULTRASOUND IMAGING IDENTIFIED THE DIAMETER OF THE ANEURYSM TO MEASURE 60 MM. IT ALSO WAS REPORTED THAT ON (B)(6) 2019 THE STUDY WAS DISCONTINUED AS THE PATIENT HAD EXPIRED.

  Patient problems: Clinical Endoleak

  MAUDE report 22529391 ↗
• InjuryFeb 19, 2025Fluid/Blood Leak; Fluid/Blood Leak

  ON (B)(6) 2015, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR A INFRARENAL ABDOMINAL AORTIC ANEURYSM MEASURING 49.5MM IN DIAMETER; AND WAS IMPLANTED WITH GORE® EXCLUDER® AAA ENDOPROSTHESIS FEATURING C3® DEPLOYMENT SYSTEM (RMT261414/(B)(6)). THE PATIENT TOLERATED THE PROCEDURE AND WAS DISCHARGED ON (B)(6) 2015. ON (B)(6) 2015, THE PATIENT UNDERWENT FOLLOW-UP COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) WHICH DETERMINE THE MAXIMUM DIAMETER OF THE ANEURYSM MEASURED 47MM. ON (B)(6) 2023, THE PATIENT UNDERWENT FOLLOW-UP COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) WHICH DETERMINE THE MAXIMUM DIAMETER OF THE ANEURYSM MEASURED 60MM AND A PROXIMAL TYPE I ENDOLEAK. ON (B)(6) 2024, THE PATIENT UNDERWENT REINTERVENTION FOR TREATMENT OF THE PROXIMAL TYPE I ENDOLEAK AND A GORE® EXCLUDER® CONFORMABLE AORTIC EXTENDER ENDOPROSTHESIS (CXA320005/ (B)(6)) WAS IMPLANTED PROXIMALLY. IT IS UNKNOWN IF ENDOLEAK RESOLVED. PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2024, THE PATIENT UNDERWENT FOLLOW-UP COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) WHICH DETERMINE THE MAXIMUM DIAMETER OF THE ANEURYSM MEASURED 60MM.

  Patient problems: Aneurysm expansion

  MAUDE report 21415401 ↗
• InjuryNov 25, 2024Device Endoleak; Device Endoleak

  ON (B)(6) 2014, THE PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE TO TREAT AN ANEURYSM UTILIZING THE GORE® EXCLUDER® AAA ENDOPROSTHESIS (STENT GRAFT TRUNK IPSILATERAL LEG C3 AND STENT GRAFT CONTRALATERAL LEG). ON (B)(6) 2024, IT WAS REPORTED THAT THERE WAS A SUSPECTED DISTAL TYPE I ENDOLEAK TO THE PREEXISTING DEVICE IN PLACE. IT WAS TOO DIFFICULT CONFIRM IT ANGIOGRAPHICALLY. A REINTERVENTION WAS PERFORMED. 2 CONTRALATERAL LEGS (PLC201000 AND PLC231200) WERE IMPLANTED ON EACH SIDE OF THE PATIENT. THE PHYSICIAN WANTED TO EXTEND BILATERALLY TO ENSURE THERE WAS AS MUCH SEAL AS POSSIBLE. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Clinical Endoleak

  MAUDE report 20775545 ↗
• InjuryOct 12, 2020Patient-Device Incompatibility; Patient-Device Incompatibility

  ON (B)(6) 2014 THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESES. THE INITIAL ANEURYSM SIZE IS REPORTEDLY UNAVAILABLE. ON (B)(6) 2017 A REINTERVENTION WAS PERFORMED WHEREBY AN AORTIC EXTENDER COMPONENT WAS PLACED TO TREAT A PROXIMAL TYPE I ENDOLEAK. NO ADDITIONAL INFORMATION REGARDING THE ENDOLEAK OR INTERVENTION WAS AVAILABLE. ON (B)(6) 2020 THE PATIENT UNDERWENT REINTERVENTION DUE TO A REPORTED GROWING ABDOMINAL AORTIC ANEURYSM. THE CAUSE OF THE ANEURYSM GROWTH WAS REPORTEDLY UNKNOWN. REPORTEDLY THE ANEURYSM MEASURED 10CM. THE DEVICE SYSTEM WAS EXPLANTED. THE EXPLANTED DEVICES WERE DISCARDED. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Aneurysm

  MAUDE report 10667439 ↗
• InjuryOct 8, 2020Patient-Device Incompatibility; Patient-Device Incompatibility

  ON (B)(6) 2014 THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESES. THE INITIAL ANEURYSM SIZE IS REPORTEDLY UNAVAILABLE. ON (B)(6) 2017 A REINTERVENTION WAS PERFORMED WHEREBY AN AORTIC EXTENDER COMPONENT WAS PLACED TO TREAT A PROXIMAL TYPE I ENDOLEAK. NO ADDITIONAL INFORMATION REGARDING THE ENDOLEAK OR INTERVENTION WAS AVAILABLE. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Aneurysm

  MAUDE report 10652023 ↗
• InjuryFeb 26, 2020Patient-Device Incompatibility; Patient-Device Incompatibility

  ON (B)(6) 2014 THE PATIENT UNDERWENT ENDOVASCULAR REPAIR USING GORE® EXCLUDER® AAA ENDOPROSTHESES. IT WAS REPORTED THAT THE PATIENT WAS LOST TO FOLLOW UP. THE PATIENT'S MEDICAL RECORDS SHOW THAT A CTA OF THE PATIENT'S ABDOMEN AND PELVIS WAS PERFORMED IN (B)(6) 2019 WHICH DID NOT DEMONSTRATE AN ENDOLEAK, AND THE NATIVE ANEURYSM SAC MEASURED 7.7CM. ON AN UNKNOWN DATE THE PATIENT WAS ADMITTED TO AN OUTSIDE HOSPITAL AFTER A FALL. REPORTEDLY A CT SCAN WAS PERFORMED ON THE PATIENT'S ABDOMEN AND PELVIS, DATE UNKNOWN. ANEURYSM ENLARGEMENT WAS REPORTED. THE AMOUNT OF ANEURYSM ENLARGEMENT IS REPORTEDLY UNKNOWN, AND THE PATIENT'S MEDICAL RECORDS SHOWED THAT THE ANEURYSM SAC MEASURED APPROXIMATELY 7.7CM. A PROXIMAL TYPE I ENDOLEAK WAS REPORTED TO BE THE CAUSE OF ANEURYSM ENLARGEMENT. THE CAUSE OF THE ENDOLEAK WAS REPORTED TO BE LOSS OF PROXIMAL WALL APPOSITION OF THE DEVICE. THE PATIENT'S AORTIC NECK WAS REPORTED TO BE LONG, BUT HAD THROMBUS OR ATHEROMA THAT WAS HOLDING THE PROXIMAL END OF THE DEVICE AWAY FROM THE WALL OF THE AORTA. THE CTA ALSO REPORTEDLY REVEALED A POSSIBLE TYPE II ENDOLEAK. NO REINTERVENTION HAS BEEN PERFORMED, AS THE PATIENT REQUIRES TIME TO RECOVER FROM THE FALL AND SUBSE

  Patient problems: Aneurysm

  MAUDE report 9757284 ↗
• InjuryAug 2, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT REFERENCED IN THIS EVENT FILE IS ENROLLED IN A POST MARKET PROSPECTIVE OBSERVATIONAL COHORT REGISTRY DESIGNED TO OBTAIN DATA ON DEVICE PERFORMANCE AND CLINICAL OUTCOMES OF PATIENTS TREATED WITH GORE ENDOVASCULAR AORTIC PRODUCTS THROUGH THE GLOBAL REGISTRY FOR ENDOVASCULAR AORTIC TREATMENT (GREAT). ON (B)(6) 2014, THE PATIENT WAS IMPLANTED WITH GORE® EXCLUDER® AAA ENDOPROSTHESES TO TREAT AN ABDOMINAL AORTIC ANEURYSM, ASD WELL AS RIGHT AND LEFT COMMON ILIAC ARTERY ANEURYSMS. THE PATIENT TOLERATED THE INITIAL PROCEDURE. THE MAXIMUM DIAMETER OF THE AORTIC ANEURYSM WAS 53MM BY ULTRASOUND. ON (B)(6) 2014 FOLLOW-UP COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) SHOWED THE MAXIMUM AORTIC DIAMETER OF THE AORTIC ANEURYSM WAS 49MM. ON (B)(6) 2015 FOLLOW-UP CTA SHOWED THE MAXIMUM DIAMETER OF THE AORTIC ANEURYSM WAS 53MM. ON (B)(6) 2018 A TYPE I ENDOLEAK WAS FOUND. ON (B)(6) 2018, THE MAXIMUM AORTIC DIAMETER OF THE AORTIC ANEURYSM WAS 56MM BY ULTRASOUND. ON (B)(6) 2018, THE MAXIMUM AORTIC DIAMETER OF THE AORTIC ANEURYSM BY CTA WAS 60MM. THE EVENT IS ONGOING.

  Patient problems: Aneurysm

  MAUDE report 8857396 ↗
• InjuryNov 15, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2014, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT USING GORE® EXCLUDER® AAA ENDOPROSTHESES FOR AN ABDOMINAL AORTIC ANEURYSM OF 56MM DIAMETER. THE PATIENT TOLERATED THE INITIAL PROCEDURE. REPORTEDLY, FROM (B)(6) 2015 TO (B)(6) 2018, THE MAXIMUM DIAMETER OF AORTIC ANEURYSM/LESION INCREASED IN SIZE FROM 56MM TO 72MM. ON (B)(6) 2018, A TYPE II ENDOLEAK OF THE MIDDLE SACRAL ARTERY WAS DETERMINED. IT WAS REPORTED THAT ON (B)(6) 2018, THE PATIENT UNDERWENT AN ANGIOGRAPHY PROCEDURE AND A COIL EMBOLIZATION PROCEDURE WAS PERFORMED TO TREAT A TYPE II ENDOLEAK OF THE MIDDLE SACRAL ARTERY. ON (B)(6) 2018, A FOLLOW UP COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) SHOWED THAT THE MAXIMUM DIAMETER OF THE AORTIC ANEURYSM WAS 65MM. A FOLLOW UP EXAM SHOWED THAT THE PATIENT WAS DOING WELL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8075754 ↗

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