GORE EXCLUDER AAA Endoprosthesis PXC271200Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00733132618217), received between Aug 20, 2021 and Mar 3, 2023 — classified as 2 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryMar 3, 2023Device Dislodged or Dislocated; Patient Device Interaction Problem; Device Dislodged or Dislocated; Patient Device Interaction Problem

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2013, THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE UTILIZING THREE GORE® EXCLUDER® AAA ENDOPROSTHESIS. REPORTEDLY, DURING A FOLLOW-UP ON (B)(6) 2023, CT SCAN REVEALED THE RIGHT ILIAC ARTERY ANEURYSM HAS GROWN (SIZE UNKNOWN) SIGNIFICANTLY COMPARED TO A PREVIOUS CT SCAN. THE GRAFT WAS NO LONGER SEALED IN THE RIGHT COMMON ILIAC, NO GRAFT MIGRATION OCCURRED AND THERE WAS A TYPE 1B ENDOLEAK BACK FLOW INTO THE SAC THAT WAS FOUND ON THE RIGHT-SIDE CONTRALATERAL LEG (PXC271200) AND A REINTERVENTION WAS PLANNED. ON (B)(6) 2023, THE PATIENT UNDERWENT A ZONE-10 COMMON ILIAC REVISION TO PRIOR EVAR PROCEDURE BY EXTENDING DISTALLY WITH TWO GORE® EXCLUDER® AAA ENDOPROSTHESIS INTO THE RIGHT EXTERNAL ILIAC ARTERY. THE TYPE 1B ENDOLEAK WAS RESOLVED AND THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Aneurysm expansion; Clinical Endoleak

  MAUDE report 16477667 ↗
• InjuryAug 20, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2012, THE PATIENT PRESENTED WITH AN UNSPECIFIED AORTIC ANEURYSM AND UNDERWENT TREATMENT UTILIZING A GORE® EXCLUDER® AAA ENDOPROSTHESIS. THE PROCEDURE WAS COMPLETED WITHOUT ISSUE. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2021, THE PATIENT UNDERWENT REINTERVENTION FOR REVISION OF THE PREVIOUSLY PLACED GORE® EXCLUDER® AAA ENDOPROSTHESIS UTILIZING TWO GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS WITH ACTIVE CONTROL (CXT A/C) AND A GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX). THE PHYSICIAN PLACED THE TWO CXT A/C DEVICES PROXIMAL AND UTILIZED THE SANDWICH GRAFT TECHNIQUE WITH THE VBX DEVICE PLACED IN THE LEFT RENAL ARTERY. THE PATIENT TOLERATED THE PROCEDURE. FURTHER INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12351124 ↗

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)