GORE EXCLUDER AAA Endoprosthesis with C3 Delivery RMT261418Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00733132610655), received between Jul 4, 2018 and Apr 22, 2025 — classified as 9 injuries.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (4 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryApr 22, 2025Fluid/Blood Leak; Fluid/Blood Leak

  ON (B)(6) 2013, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF FOR ZONE 9 INFRARENAL ABDOMINAL AORTIC ANEURYSM AND WAS IMPLANTED WITH GORE® EXCLUDER® AAA ENDOPROSTHESES FEATURING C3® DELIVERY SYSTEM. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2025, THE PATIENT UNDERWENT REINTERVENTION FOR AN UNKNOWN ENDOLEAK (SUSPECTED TYPE II OR PROXIMAL TYPE I ENDOLEAK) AND SLOW PERSISTENT GROWTH OF THE ANEURYSM (AMOUNT UNKNOWN). A GORE® EXCLUDER® AORTIC EXTENDER WAS IMPLANTED TO PROVIDE 5MM ADDITIONAL COVERAGE UP TO THE RENAL ARTERIES. ADDITIONALLY, THE PHYSICIAN CHOSE TO TREAT A SMALL ULCERATION THE PATIENT HAD DEVELOPED AT THE VERY DISTAL EDGE OF THE RIGHT COMMON ILIAC ARTERY (RCIA). THE PHYSICIAN REPORTED THE LIMB LOOKED WELL SEALED BUT CHOSE TO TREAT THE ULCERATION BY EMBOLIZING THE INTERNAL ILIAC ARTERY (IIA), AND EXTEND COVERAGE DOWN TO THE EXTERNAL ILIAC ARTERY WITH COVERAGE OF THE EMBOLIZED IIA. A GORE® EXCLUDER® CONTRALATERAL LEG WAS THEN IMPLANTED TO COVER THE AREA OF EMBOLIZATION AND SMALL ULCERATION. THE PHYSICIAN REPORTS THE ULCERATION WAS NOT DEEMED TO BE ASSOCIATED WITH ANY OF THE PREVIOUSLY IMPLANTED GORE DEVICES AND NO ENDOLEAK WAS CONFIRMED. THE PATIENT TOLERATED THE PROC

  Patient problems: Clinical Endoleak

  MAUDE report 21886519 ↗
• InjuryAug 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO GORE A GORE® EXCLUDER® AAA ENDOPROSTHESIS WAS IMPLANTED ON (B)(6) 2014 IN ORDER TO TREAT AN ABDOMINAL AORTIC ANEURYSM MEASURED 60 MM. AN ANEURYSM ENLARGEMENT (SIZE UNKNOWN) WITH ONSET DATE OF AUGUST 28, 2020 WAS REPORTED. THE PATIENT UNDERWENT AN UNKNOWN ADDITIONAL TREATMENT ON (B)(6) 2020. ON THE FOLLOW-UP EXAM ON (B)(6) 2020, AN ABDOMINAL AORTIC ANEURYSM OF 85 MM WAS MEASURED. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

  Patient problems: Aneurysm expansion

  MAUDE report 19926956 ↗
• InjuryMay 23, 2024Fluid/Blood Leak; Fluid/Blood Leak

  THE FOLLOWING DETAILS WERE REPORTED TO GORE: COULD YOU PROVIDE ME WITH THE IMPLANT INFORMATION ON THIS PATIENT? INDEX PROCEDURE WAS DONE BY DR (B)(6), ROUGHLY 10 YEARS AGO. HE HAS WHAT APPEARS TO BE A TYPE 3 ENDOLEAK IN THE AREA OF THE CONTRALATERAL GATE. THE LEAK WAS SMALL UNTIL DR (B)(6) PLACED A CATHETER INSIDE THE GATE SECTION AND SHOT A PICTURE ¿ THEN THE LEAK WAS VERY PROMINENT. BY CT SCAN YOU CAN SEE THAT THE LIMB/GATE LOOKS IRREGULAR ¿ DR (B)(6) IS SUSPICIOUS THAT THERE IS A TEAR/POSSIBLE STENT FRACTURE. THE PLAN IS TO BRING HIM BACK AND RELINE THE LIMB. NO SURGERY DATE AS OF YET, BUT HE IS HOPING TO PUT IT ON FOR 6/4 TO FOLLOW THE FIRST EVAR. THANKS.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 19387717 ↗
• InjuryJan 23, 2024Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem; Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem

  ON (B)(6), 2014, IT IS REPORTED THAT A PATIENT PRESENTED WITH A COMMON ILIAC ANEURYSM ON THE LEFT SIDE (MEASURED 33 MM) WAS TREATED WITH A GORE® EXCLUDER® AAA ENDOPROSTHESIS. ON (B)(6), 2017, THE PATIENT'S ANEURYSM GREW TO 42 MM DUE TO A TYPE II ENDOLEAK. ON (B)(6) 2017, ONYX® EMBOLIZATION WAS PERFORMED. NO FURTHER SAC ENLARGEMENT WAS DETECTED DURING THE FOLLOW-UPS (THE LAST ONE DOCUMENTED ON (B)(6), 2022). IT WAS ADDITIONALLY REPORTED THAT THE PATIENT PASSED AWAY ON (B)(6), 2022 OF UNKNOWN CAUSE (EVENT NOT RELATED TO DEVICE OR PROCEDURE).

  Patient problems: Aneurysm expansion; Clinical Endoleak

  MAUDE report 18562165 ↗
• InjuryMar 15, 2023Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem; Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2013, A PATIENT PRESENTING WITH AN ABDOMINAL AORTIC ANEURYSM WAS TREATED WITH A GORE® EXCLUDER® AAA ENDOPROSTHESIS. ON (B)(6) 2013, THE MAXIMUM DIAMETER OF THE AORTIC ANEURYSM WAS MEASURED AS 100 MM VIA CT IMAGING. ON (B)(6) 2022, ANEURYSM GROWTH WAS DETECTED. NO CT IMAGING WAS DOCUMENTED ON THIS DATE. THE GROWTH AMOUNT IS UNKNOWN. A TYPE II ENDOLEAK WAS REPORTED BY THE PHYSICIAN. CT IMAGING ON (B)(6) 2022 SHOWED A MAXIMUM DIAMETER OF THE AORTIC ANEURYSM OF 130 MM. ON (B)(6) 2023, THE ANEURYSM GROWTH WAS TREATED WITH COIL EMBOLIZATION.

  Patient problems: Aneurysm; Aneurysm expansion

  MAUDE report 16548043 ↗
• InjuryNov 10, 2022Biocompatibility; Biocompatibility

  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) 2022, THE PATIENT PRESENTED WITH A SUSPECTED INFECTION OF THE GRAFTS, THE PATIENT WAS CONVERTED TO OPEN REPAIR AND COMPLETE EXPLANT OF THE GRAFTS WAS PERFORMED. THE EXPLANTED GRAFTS WERE REPLACED WITH A PROSTHETIC AORTO BI-ILIAC GRAFT. CASE WAS COMPLETED WITHOUT INCIDENT AND PATIENT IS REPORTEDLY DID OK. THE EXPLANTED GRAFTS WERE DISCARDED BY THE SITE. INFECTION WAS CONFIRMED HOWEVER THE CAUSE OF THE INFECTION WAS NOT DETERMINED.

  Patient problems: Aneurysm

  MAUDE report 15777532 ↗
• InjuryOct 19, 2020Patient-Device Incompatibility; Patient-Device Incompatibility

  ON AN UNKNOWN DATE IN 2014 THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESES. THE ANEURYSM REPORTEDLY MEASURED 5.5CM. ON (B)(6) 2020 THE FIELD SALES ASSOCIATE WAS MADE AWARE OF ANEURYSM GROWTH. THE ANEURYSM REPORTEDLY MEASURED 6.9CM. REPORTEDLY THERE WAS NO EVIDENCE OF AN ENDOLEAK. ON (B)(6) 2020 THE PATIENT UNDERWENT REINTERVENTION TO TREAT THE ANEURYSM ENLARGEMENT. AN AORTIC EXTENDER COMPONENT AND TWO ADDITIONAL CONTRALATERAL LEG COMPONENTS WERE USED TO RELINE THE ORIGINAL DEVICE SYSTEM. THE PHYSICIAN REPORTEDLY SUSPECTED THAT THE ANEURYSM ENLARGEMENT MAY BE DUE TO ENDOTENSION. THERE WERE NO FURTHER REPORTED ISSUES. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Aneurysm

  MAUDE report 10702348 ↗
• InjuryJul 18, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2013 A PATIENT UNDERWENT TREATMENT OF A 70MM ABDOMINAL AORTIC ANEURYSM WITH GORE® EXCLUDER® AAA ENDOPROSTHESES. ON (B)(6) 2013 THE ANEURYSM MEASURED 52MM. ON (B)(6) 2016 THE ANEURYSM MEASURED 45MM. ON (B)(6) 2018 THE PATIENT PRESENTED WITH A LEFT GROIN SWELLING. ULTRASOUND REVEALED A LARGE LEFT ILIAC ARTERY ANEURYSM. THIS ANEURYSM WAS PRE-EXISTING AND NOT IN THE TREATMENT ZONE OF THE GORE DEVICES. ON (B)(6) 2018 THE PATIENT UNDERWENT EMERGENCY OPEN REPAIR OF THE EXPANDING ANEURYSM WITH A 6MM DACRON GRAFT. ON (B)(6) 2018 THE SUBJECT HAD A CARDIAC ARREST SECONDARY TO SEPTIC SHOCK. THE FAMILY DECLINED RESUSCITATION. ON (B)(6) 2018 THE SUBJECT EXPIRED.

  Patient problems: Aneurysm

  MAUDE report 7699413 ↗
• InjuryJul 4, 2018Patient-Device Incompatibility; Patient-Device Incompatibility

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6), 2011, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM MEASURING 52 MM IN DIAMETER AND WAS THEREFORE TREATED WITH GORE® EXCLUDER® AAA ENDOPROSTHESES. ON (B)(6) 2018, FOLLOW-UP ULTRASOUND EXAMINATION REVEALED A TYPE II ENDOLEAK OF A LUMBAR ARTERY AND AN ANEURYSM DIAMETER OF 63 MM. ON (B)(6) 2018, THE LUMBAR ARTERY WAS EMBOLIZED.

  Patient problems: No Code Available

  MAUDE report 7662317 ↗

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)