GORE EXCLUDER AAA Endoprosthesis PXC271000Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00733132618224), received between Jan 11, 2019 and Sep 20, 2023 — classified as 2 injuries.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (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.

• InjurySep 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FIELD SALES ASSOCIATE (FSA) REPORTED THE FOLLOWING: ON (B)(6) 2023, THE PATIENT WAS IMPLANTED WITH A GORE® EXCLUDER® AAA ENDOPROSTHESES TO TREAT AN ABDOMINAL AORTIC ANEURYSM. THE PHYSICIAN ALSO COILED A LEFT INTERNAL ILIAC ANEURYSM. THE PATIENT TOLERATED THE PROCEDURE. IT WAS REPORTED THE PATIENT PRESENTED ON (B)(6) 2023, WITH A PREVIOUSLY PLACED GORE® EXCLUDER® AAA ENDOPROSTHESES, THAT STILL EXHIBITED EXCELLENT PROXIMAL AND DISTAL SEAL. A LEFT COMMON ILIAC ARTERY ANEURYSM HAD FURTHER DEVELOPED DISTAL TO THE PLACEMENT OF THE ORIGINAL ENDOGRAFT (PXC271000 L/S#; (B)(6)). THIS WAS NOT A NEW ANEURYSM; THE AREA WAS ALREADY DISEASED AND NOTED FROM PREVIOUS IMPLANT PROCEDURE. THE PHYSICIAN WANTED TO PROPHYLACTICALLY COVER THIS AREA TO ENSURE NO FURTHER ISSUES IN THE LEFT ILIAC ARTERY DUE TO THE PATIENT¿S ADVANCED AGE. THE PHYSICIAN COILED THE LEFT INTERNAL ILIAC ANEURYSM ON (B)(6) 2023, AND DECIDED TO EXTEND THE EXISTING ENDOGRAFT INTO THE LEFT EXTERNAL ILIAC ARTERY ON (B)(6) 2023. THIS WAS ACCOMPLISHED USING TWO GORE® EXCLUDER® AAA ENDOPROSTHESES . AT THE CONCLUSION OF THE CASE, BOTH DEVICES WERE DEPLOYED ACCURATELY AND WITHOUT ANY ISSUES AND THE PROCEDURE WAS COMPLETED. PATIENT TOLE

  Patient problems: Aneurysm

  MAUDE report 17781681 ↗
• InjuryJan 11, 2019Patient-Device Incompatibility; Patient-Device Incompatibility

  ON (B)(6) 2012, THE PATIENT UNDERWENT TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESES. ON AN UNKNOWN DATE, IMAGING IDENTIFIED AN UNKNOWN AMOUNT OF ANEURYSMAL GROWTH WITHOUT SIGN OF AN ENDOLEAK. THE CAUSE OF GROWTH IS REPORTEDLY UNKNOWN. ON (B)(6) 2018, THE PATIENT WAS IMPLANTED EXTENDING FROM CONTRALATERAL LEG COMPONENT (LOT NUMBER UNKNOWN) WITH A GORE® ILIAC BRANCH ENDOPROSTHESIS AND A GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS TO PRESERVE THE RIGHT INTERNAL ILIAC FROM CONTINUED DISEASE PROGRESSION OF THE ORIGINAL ANEURYSM. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Aneurysm

  MAUDE report 8242011 ↗

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