GORE EXCLUDER AAA Endoprosthesis with C3 Delivery RMT231216Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00733132610525), received between Mar 11, 2019 and Apr 13, 2022 — classified as 2 injuries, 1 malfunction.

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

• InjuryApr 13, 2022Microbial Contamination of Device; Microbial Contamination of Device

  ON (B)(6) 2014, A PATIENT PRESENTED WITH AN ABDOMINAL AORTIC ANEURYSM (MEASURED 56.5 MM) WAS TREATED WITH A GORE® EXCLUDER® AAA ENDOPROSTHESIS. ON (B)(6) 2022, IT WAS REPORTED THAT THE PATIENT SUFFERED SPONDYLODISCITIS WITH INTERVERTEBRAL ABSCESS. ON (B)(6) 2022, THE PATIENT UNDERWENT CONVERSION TO OPEN REPAIR. ON (B)(6) 2022, IT WAS REPORTED THAT THE PATIENT HAD EXPIRED.

  Patient problems: Abscess; Bacterial Infection

  MAUDE report 14101531 ↗
• InjuryMar 15, 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 POSSIBLE TYPE III ENDOLEAK (TEAR IN MATERIAL) WITH ANEURYSM SAC ENLARGEMENT (AMOUNT OF ENLARGEMENT IS UNKNOWN). ON (B)(6) , 2022, THE PHYSICIAN REINTERVENED AND IMPLANTED AN AORTIC EXTENDER ENDOPROSTHESIS AND RELINED BOTH LIMBS WITH CONTRALATERAL LEG ENDOPROSTHESES. DURING THE REINTERVENTION, NO TYPE III ENDOLEAK WAS FOUND, IT IS UNKNOWN WHAT TYPE OF ENDOLEAK WAS PRESENT. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Aneurysm

  MAUDE report 13773318 ↗
• MalfunctionMar 11, 2019Activation Failure; Activation Failure

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2019 A PATIENT WAS UNDERGOING TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM WITH A GORE® EXCLUDER® AAA ENDOPROSTHESIS FEATURING C3® DELIVERY SYSTEM. THE DEVICE WAS ADVANCED OVER A LUNDERQUIST WIRE THROUGH AN 18FR GORE® DRYSEAL SHEATH. THE SHEATH WAS RETRACTED FOR DEPLOYMENT. THE FIRST STAGE OF DEPLOYMENT WAS ATTEMPTED BUT IT DID NOT DEPLOY. THE BACK-UP DEPLOYMENT HATCH WAS OPENED AND ATTEMPTS TO DEPLOY THE SYSTEM USING THE BACK-UP LINES WERE MADE. HOWEVER THE FIRST STAGE OF DEPLOYMENT COULD NOT BE ACCOMPLISHED. THE SYSTEM WAS REMOVED FROM THE PATIENT AND A DECISION WAS MADE TO RE-SCHEDULE THE PROCEDURE. THERE WAS NO INJURY TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8408116 ↗

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