GORE EXCLUDER AAA Endoprosthesis with C3 Delivery RMT281216Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00733132610686), received between Feb 3, 2020 and Mar 25, 2024 — classified as 6 injuries.

The most frequently reported specific device problem is “Fluid/Blood Leak” (1 report).

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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryMar 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2015, A PATIENT PRESENTING WITH ABDOMINAL AORTIC ANEURYSM WAS TREATED WITH A GORE® EXCLUDER® AAA ENDOPROSTHESIS. ON (B)(6) 2020, THE PATIENT PRESENTED WITH RUPTURE OF THE ABDOMINAL AORTIC ANEURYSM. THE PATIENT WAS TREATED WITH AN AORTOBIILIAC BYPASS. ON (B)(6) 2020, THE PATIENT PRESENTED WITH HEMOPERITONEUM DUE TO RUPTURE OF THE ANASTOMOSIS BETWEEN LEFT ILIAC BRANCH OF PREVIOUS ENDOVASCULAR REPAIR AND SURGICAL ILIAC GRAFT. THE PATIENT WAS TREATED WITH AN ADDITIONAL DEVICE THAT DAY.

  Patient problems: Ruptured Aneurysm

  MAUDE report 18969248 ↗
• InjuryJul 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FIELD SALES ASSOCIATE (FSA) REPORTED THE FOLLOWING INFORMATION: ON (B)(6) 2013, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN INFRARENAL ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® ENDOPROSTHESES. ON (B)(6) 2023, THE PATIENT UNDERWENT REINTERVENTION ENDOVASCULAR TREATMENT TO RELINE ONE OF THE GORE® EXCLUDER® ENDOPROSTHESES LIMBS. THE PATIENT TOLERATED THE REINTERVENTION. THERE WAS ANEURYSM SAC ENLARGEMENT (AMOUNT OF GROWTH IS UNKNOWN, AN UNKNOWN TYPE ENDOLEAK). ON (B)(6) 2023, THE PHYSICIAN EXPLANTED ALL THE GORE® EXCLUDER® ENDOPROSTHESES LIMBS AND PERFORMED AN OPEN REPAIR. THE ANEURYSM SAC CONTINUED TO ENLARGE (AMOUNT OF GROWTH IS UNKNOWN, AN UNKNOWN TYPE ENDOLEAK). THE EXPLANTED DEVICES WERE DESTROYED AT THE HOSPITAL. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Aneurysm

  MAUDE report 17375042 ↗
• InjuryJun 15, 2023Fluid/Blood Leak; Fluid/Blood Leak

  ON (B)(6) 2023, THE PATIENT UNDERWENT REINTERVENTION AND OPEN EXPLORATION AND REPAIR OF THE AAA WAS PERFORMED FOR AN INDETERMINATE ENDOLEAK AND ANEURYSM EXPANSION. THE MAXIMUM DIAMETER OF THE ANEURYSM AT THIS TIME WAS NOT KNOWN. THE PROCEDURE RESOLVED THE ENDOLEAK. THE TYPE ENDOLEAK WAS NOT ABLE TO BE DETERMINED. THE PATIENT WAS DISCHARGED ON (B)(6) 2023 AND AT THE ONE MONTH FOLLOW-UP ON (B)(6) 2023, THE PATIENT WAS DOING WELL.

  Patient problems: Aneurysm

  MAUDE report 17140463 ↗
• InjuryFeb 7, 2023Leak/Splash; Adverse Event Without Identified Device or Use Problem; Leak/Splash; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO GORE THAT ON (B)(6) 2012, THE PATIENT PRESENTED WITH AN ABDOMINAL AORTIC ANEURYSM AND WAS TREATED WITH A GORE® EXCLUDER® AAA ENDOPROSTHESIS. ENDOLEAK WAS DETECTED IN (B)(6) 2020. ANEURYSM GROWTH IS REPORTED AS 2CM IN ONE YEAR. IT WAS STATED THAT ON (B)(6) 2022, THE ENDOPROSTHESES WAS EXPLANTED DUE TO TYPE II ENDOLEAK WHICH PERFUSED THE LUMBAR ARTERIES. NO HARM TO THE PATIENT.

  Patient problems: Clinical Endoleak

  MAUDE report 16311920 ↗
• InjuryNov 9, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE THROUGH (B)(6): ON (B)(6) 2014 THE PATIENT UNDERWENT ENDOVASCULAR REPAIR OF AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESES. THE MAXIMUM DIAMETER OF THE ANEURYSM MEASURED 56 MM. THE PATIENT'S INFRARENAL NECK ANGLE MEASURED 10 DEGREES. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2021, ANGIOGRAPHY WAS PERFORMED, AND AS A RESULT, THE PHYSICIAN PERFORMED A TRANSCAVAL COIL EMBOLIZATION AND IMPLANTED AN ADDITIONAL AORTIC ENDOGRAFT. PATIENT TOLERATED THE PROCEDURE.

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

  MAUDE report 12780050 ↗
• InjuryFeb 3, 2020Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  ON (B)(6) 2013, THE PATIENT WAS TREATED FOR AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESES. ON (B)(6) 2020, THE PATIENT UNDERWENT REVISION SURGERY TO TREAT A TYPE IB ENDOLEAK. PLC181400/LOT 20382240 WAS IMPLANTED. THE PHYSICIAN BELIEVES THE ENDOLEAK WAS CAUSED BY THE LIMB OF THE ORIGINAL IMPLANT NOT EXTENDING FAR ENOUGH INTO THE LEFT ILIAC ARTERY. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Aneurysm

  MAUDE report 9659829 ↗

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)