GORE EXCLUDER AAA Endoprosthesis with C3 Delivery RMT231414Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00733132610556), received between May 21, 2019 and Jan 9, 2023 — classified as 7 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryJan 9, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  ON (B)(6) 2013, THE PATIENT WAS TREATED FOR AN ABDOMINAL AORTIC ANEURYSM. THE PHYSICIAN IMPLANTED THREE GORE® EXCLUDER® AAA ENDOPROSTHESES. THE PATIENT TOLERATED THE PROCEDURE. ON A FOLLOW UP VISIT ON (B)(6) 2022, A POSSIBLE TYPE IA ENDOLEAK WAS NOTED ON A NON-CONTRASTED ANGIOGRAM. A REINTERVENTION WAS PERFORMED ON (B)(6) 2022, WITH AN ADDITIONAL ENDOPROSTHESIS BEING IMPLANTED. THE PATIENT TOLERATED THE PROCEDURE.. THE CAUSE OF THE ENDOLEAK, IS REPORTED TO EITHER BE DEVICE MIGRATION OR NECK DILATATION.

  Patient problems: Clinical Endoleak

  MAUDE report 16121286 ↗
• InjurySep 6, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FIELD SALES ASSOCIATE REPORTED THE FOLLOWING: ON (B)(6) 2014, THE PATIENT WAS IMPLANTED WITH A GORE® EXCLUDER® AAA ENDOPROSTHESES TO TREAT AN ABDOMINAL AORTIC ANEURYSM. THE PATIENT TOLERATED THE PROCEDURE. IT WAS REPORTED THAT IMAGES (MODALITY AND DATE IS UNKNOWN), REVEALED A PROXIMAL TYPE I ENDOLEAK. THERE WAS ANEURYSM SAC ENLARGEMENT (AMOUNT OF ENLARGEMENT IS UNKNOWN). THERE WAS A REINTERVENTION ON (B)(6) 2022. THE PHYSICIAN IMPLANTED A GORE® EXCLUDER® AAA ENDOPROSTHESIS AORTIC EXTENDER IN THE PROXIMAL SEAL ZONE FROM THE ORIGINAL PROCEDURE. THE ENDOLEAK WAS RESOLVED. THE PATIENT TOLERATED THE REINTERVENTION PROCEDURE.

  Patient problems: Aneurysm

  MAUDE report 15364813 ↗
• InjuryNov 19, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING WAS REPORTED BY THE GORE FIELD SALES AGENT (FSA): ON (B)(6) 2012, THE PATIENT PRESENTED WITH AN ANEURYSM AND HAD AN EVAR REPAIR USING TWO GORE® EXCLUDER® AAA ENDOPROSTHESES. THE SURGERY WAS REPORTEDLY A SUCCESS AND THE PATIENT TOLERATED THE PROCEDURE. ON AN UNKNOWN DATE IN 2021 THE PATIENT HAD A CT SCAN AND AN INDETERMINATE ENDOLEAK WAS FOUND AND THE PATIENT WAS SCHEDULED FOR A RE-INTERVENTION. ON (B)(6) 2021, THE PATIENT HAD A RE-INTERVENTION WHERE IT WAS REPORTEDLY FOUND THAT THE PATIENT HAD A TYPE II ENDOLEAK. THREE ADDITIONAL EXCLUDER DEVICES WERE IMPLANTED (2 AORTIC EXTENDERS AND A CONTRA LEG). IT WAS ALSO REPORTEDLY FOUND THAT THE HYPOGASTRIC ARTERY WAS FEEDING THE ANEURYSM SAC, SO THE PHYSICIAN MADE THE DECISION TO COIL THE ARTERY. THE PATIENT REPORTEDLY TOLERATED THE SURGERY. THE PHYSICIAN STATED THE ENDOLEAK WAS MOST LIKELY DUE TO THE PATIENTS AGE AND LIFESTYLE.

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

  MAUDE report 12845154 ↗
• InjuryJul 9, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2012 A PATIENT UNDERWENT TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM IN THE GRT10-11 STUDY WITH GORE¿ EXCLUDER¿ AAA ENDOPROSTHESES. ON (B)(6) 2021 THE PATIENT EXHIBITED A TYPE II ENDOLEAK WHICH WAS TREATED BY MEANS OF BIOLOGICAL GLUE. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Aneurysm

  MAUDE report 12144112 ↗
• InjuryDec 2, 2020Fracture; Insufficient Device Problem Information; Fracture; Insufficient Device Problem Information

  ON (B)(6) 2014, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM USING TWO GORE® EXCLUDER® AAA ENDOPROSTHESES. ACCORDING TO THE REPORT, ENSUING FOLLOW-UP EXAMINATIONS (DATES UNKNOWN) IDENTIFIED A PERSISTENT AND UNKNOWN ENDOLEAK CONTRIBUTING TO ANEURYSM ENLARGEMENT (MEASUREMENTS NOT AVAILABLE). A TYPE IIIB ENDOLEAK WITH POSSIBLE STENT GRAFT FRACTURE WAS SUSPECTED, INVOLVING THE MAIN BODY ON THE IPSILATERAL (RIGHT) SIDE IN THE REGION OF THE FLOW DIVIDER. THE PHYSICIAN CONTINUED TO MONITOR THE PATIENT. ON (B)(6) 2020, A RE-INTERVENTION PROCEDURE WAS PERFORMED. AN INITIAL ANGIOGRAM REPORTEDLY DEMONSTRATED THE SUSPECTED ENDOLEAK. THE PHYSICIAN OCCLUDED THE RIGHT COMMON ILIAC LIMB, THEN PERFORMED AORTIC-UNI-ILIAC STENT GRAFTING WITH FEMORO-FEMORAL BYPASS TO REVASCULARIZE THE RIGHT SIDE. AT THE CONCLUSION OF THE PROCEDURE, A COMPLETION ANGIOGRAM REPORTEDLY REVEALED A PERSISTENT ENDOLEAK OF UNKNOWN ORIGIN. THE ENDOLEAK REPORTEDLY PRESENTED IN THE VERY EARLY PHASE OF CONTRAST INJECTION WITH CONTRAST IN THE ANTERIOR ASPECT OF THE ANEURYSM, BELOW THE NECK AT THE LEVEL OF THE FLOW DIVIDER, WITH NO APPARENT INVOLVEMENT OF LUMBAR OR INFERIOR MESENTERIC ARTERIES. THE P

  Patient problems: No Code Available

  MAUDE report 10931381 ↗
• InjuryMay 15, 2020Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  ON (B)(6) 2011, THE PATIENT WAS TREATED FOR AN ABDOMINAL AORTIC ANEURYSM. A GORE® EXCLUDER® AAA ENDOPROSTHESIS AND 3 CUFFS WERE IMPLANTED, AND THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2020, THE PATIENT PRESENTED STABLE WITH A RUPTURED ANEURYSM, AND WAS TREATED FOR A TYPE 1A ENDOLEAK. THE PATIENT HAD NOT BEEN SEEN IN FOLLOW UP SINCE THE INDEX PROCEDURE. FOUR GORE® EXCLUDER® AAA ENDOPROSTHESES WERE IMPLANTED, ALONG WITH SIX APTUS HELIX ENDOSTAPLES. THE PATIENT WAS AWAKE DURING THE PROCEDURE, AND TOLERATED IT WELL.

  Patient problems: Aneurysm

  MAUDE report 10061262 ↗
• InjuryMay 21, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  ON (B)(6) 2014, THE PATIENT HAD A FULL ENDOVASCULAR REPAIR USING GORE® EXCLUDER® AAA ENDOPROSTHESES. ON AN UNKNOWN DATE DURING A YEARLY CT SCAN THE PHYSICIAN FOUND A TYPE 1B ENDOLEAK. ON (B)(6) 2019, THE PATIENT HAD A RE-INTERVENTION WHERE TWO ADDITIONAL GORE® EXCLUDER® AAA ENDOPROSTHESES WERE IMPLANTED TO EXTEND DISTALLY INTO THE ILIAC ARTERIES. IT WAS ALSO REPORTED THAT THE INTERNAL ILIAC ARTERY WAS COILED. THE PATIENT REPORTEDLY TOLERATED THE PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8629705 ↗

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)