GORE EXCLUDER Conf AAA Endo - Trunk-Ipsilateral CXT281212Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00733132651047), received between Sep 9, 2022 and Sep 9, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Difficult or Delayed Activation” (1 report).

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 9, 2022Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse; Difficult or Delayed Activation; Material Deformation

  ON (B)(6) 2022, THE PATIENT WAS ADMITTED FOR ENDOVASCULAR AORTIC REPAIR OF AN ABDOMINAL AORTIC ANEURYSM USING A GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS. REPORTEDLY, DURING DEPLOYMENT THE DEVICE WAS RECONSTRAINED FOUR SEPARATE TIMES. AS REPORTED, EACH TIME THE DEVICE WAS RECONSTRAINED IT REOPENED WITH ONE SIDE SLIGHTLY LOWER (1960-E:-OTHER/UNKNOWN). AS REPORTED, FOLLOWING THE FOURTH ATTEMPT TO REPOSITION AND REOPEN THE ENDOPROSTHESIS THE PHYSICIAN DECIDED TO PROCEED BY LEAVING THE ENDOPROSTHESIS WHERE IT WAS, WITH ONE SIDE OF THE LEADING EDGE SLIGHTLY LOWER, AND ADDED A GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS AORTIC EXTENDER COMPONENT. THE PATIENT WAS TREATED EFFECTIVELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15396871 ↗