GORE EXCLUDER AAA Endoprosthesis PXT281216Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00733132610273), received between Jul 31, 2019 and Jul 31, 2019 — classified as 1 injury.

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

• InjuryJul 31, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2008, THE PATIENT HAD THREE GORE® EXCLUDER® AAA ENDOPROSTHESES IMPLANTED TO REPAIR AN ABDOMINAL AORTIC ANEURYSM (AAA). ON (B)(6) 2019, THE PATIENT HAD A CT SCAN DUE TO A COMPLAINT OF ABDOMINAL PAIN AND ENLARGEMENT OF HER ABDOMINAL AREA. THE PHYSICIAN DISCUSSED HAVING AN ADDITIONAL SURGERY TO REPAIR THE AAA, BUT THE PATIENT DECLINED. ON (B)(6) 2019, THE PATIENT PRESENTED AT THE EMERGENCY DEPARTMENT WITH A RUPTURED RIGHT COMMON ILIAC ARTERY. IT WAS REPORTED THAT DUE TO THE GROWTH OF THE AAA, THERE WAS NO LONGER A SUFFICIENT SEAL FROM HER PREVIOUSLY IMPLANTED GRAFTS AND THE ARTERY BECAME PRESSURIZED AND RUPTURED. THE RIGHT COMMON ILIAC ARTERY WAS EXTENDED WITH TWO GORE® EXCLUDER® AAA ENDOPROSTHESES TO REPAIR THE RUPTURE. THE PHYSICIAN ALSO DECIDED TO IMPLANT TWO ADDITIONAL GORE® EXCLUDER® AAA ENDOPROSTHESES. AN AORTIC CUFF WAS PLACED JUST BELOW THE RENAL ARTERIES AND A CONTRALATERAL LIMB WAS PLACED TO EXTEND THE LEFT LIMB. REPORTEDLY THERE WERE NO LEAKS IN THOSE LOCATIONS, BUT HE PHYSICIAN FELT IT BEST TO GAIN ADDITIONAL COVERAGE. THE PATIENT REPORTEDLY TOLERATED THE PROCEDURE.

  Patient problems: Aneurysm; Pain

  MAUDE report 8846748 ↗

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)