GORE EXCLUDER AAA Endoprosthesis PXC161000Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00733132609970), received between Aug 16, 2022 and Nov 13, 2024 — classified as 2 injuries.

The most frequently reported specific device problem is “Therapeutic or Diagnostic Output 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryNov 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2012, A PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESES. A CONTRALATERAL LEG WAS IMPLANTED IN THE RIGHT LEG. ANOTHER CONTRALATERAL LEG WAS IMPLANTED IN THE LEFT LEG. ON UNKNOWN DATE, AT A FOLLOW UP, AN ENLARGEMENT OF THE ANEURYSM WAS OBSERVED. ON (B)(6) 2024, A REINTERVENTION WAS PERFORMED. THE CAUSE OF THE ANEURYSM ENLARGEMENT WAS UNKNOWN; HOWEVER, A LUMBAR ARTERY WAS EMBOLIZED FOR A SUSPECTED TYPE II ENDOLEAK, ADDITIONAL STENT GRAFT WAS IMPLANTED TO EXTEND DISTALLY IN THE RIGHT LEG AFTER COIL EMBOLIZATION OF THE RIGHT INTERNAL ILIAC ARTERY, AND ADDITIONAL STENT GRAFTS WERE IMPLANTED INTO THE LEFT LEG. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Aneurysm expansion

  MAUDE report 20679562 ↗
• InjuryAug 16, 2022Therapeutic or Diagnostic Output Failure; No Apparent Adverse Event; No Apparent Adverse Event

  ON (B)(6) 2012, THE PATIENT WAS IMPLANTED WITH A GORE® EXCLUDER® AAA ENDOPROSTHESIS CONTRALATERAL LEG COMPONENT, FOR TREATMENT OF AN ANEURYSM. AS REPORTED, THE GORE DEVICE APPEARED TO HAVE BEEN EXTENDED FROM A NON-GORE DEVICE AND WAS IMPLANTED ON THE RIGHT SIDE OF THE PATIENT. ACCORDING TO MEDICAL RECORDS THERE WAS AN ANEURYSM LOCATED DOWN THE RIGHT ILIAC ARTERY. ON (B)(6) 2017 MEDICAL RECORDS ALSO INDICATE FOLLOW UP EXAMINATION FOR A TYPE II ENDOLEAK FOLLOWING A COIL EMBOLIZATION IN AN UNSPECIFIED LOCATION. ON (B)(6) 2022, THE PATIENT PRESENTED WITH AN UNSPECIFIED DEGREE OF ANEURYSM ENLARGEMENT. AS REPORTED, IMAGING SHOWED WHAT LOOKED LIKE A TYPE III ENDOLEAK ON THE LEFT SIDE OF THE PATIENT. ON (B)(6) 2022, THE PATIENT UNDERWENT A REINTERVENTION. AS REPORTED, THE PHYSICIAN DECIDED TO LINE BOTH THE RIGHT AND LEFT COMMON ILIAC ARTERIES WITH GORE EXCLUDER ENDOPROSTHESES. AS REPORTED, A TYPE II ENDOLEAK WAS IDENTIFIED ORIGINATING FROM THE ILIOLUMBAR ARTERY. AS REPORTED, COIL EMBOLIZATION WAS PERFORMED THROUGH THE INTERNAL ILIAC TO ADDRESS THE TYPE II ENDOLEAK. THE REINTERVENTION PROCEDURE WENT SMOOTHLY. THE PATIENT TOLERATED THE PROCEDURE. AS REPORTED, THERE WAS NO EVIDENCE OF AN ENDO

  Patient problems: Aneurysm; No Clinical Signs, Symptoms or Conditions

  MAUDE report 15235590 ↗

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