GORE EXCLUDER AAA Endoprosthesis PXC231400Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00733132618293), received between Jul 13, 2022 and Jul 13, 2022 — classified as 1 injury.

The most frequently reported specific device problem is “Migration” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryJul 13, 2022Migration; Migration

  ON (B)(6) 2012, THE PATIENT WAS IMPLANTED WITH GORE® EXCLUDER® AAA ENDOPROSTHESES INCLUDING A TRUNK IPSILATERAL LEG COMPONENT AND TWO CONTRALATERAL LEG COMPONENTS FOR TREATMENT OF AN AORTIC ANEURYSM. ON (B)(6) 2022, THE PATIENT WAS ADMITTED FOR PAIN AND UNDERWENT A REINTERVENTION. AS REPORTED, A GORE® EXCLUDER® AAA ENDOPROSTHESIS CONTRALATERAL LEG COMPONENT (B)(4) HAD DISLODGED AND MIGRATED UP INTO THE ANEURYSM SAC (APPROXIMATELY 4CM). AS REPORTED, A DISTAL TYPE 1 ENDOLEAK WAS CONFIRMED. AS REPORTED, THERE WAS AN UNKNOWN DEGREE OF ANEURYSM ENLARGEMENT, BUT NOT A LOT. AS REPORTED, THE CAUSE WAS ONGOING DISEASE PROGRESSION. AS REPORTED, THE REINTERVENTION PROCEDURE INVOLVED ADDITIONAL GRAFT IMPLANTATION DOWN THE RIGHT COMMON ILIAC. REPORTEDLY THE PATIENT TOLERATED THE PROCEDURE. IT WAS NOTED THAT THE PATIENT HAD A LONGER THAN AVERAGE AORTA.

  Patient problems: Aneurysm

  MAUDE report 14999646 ↗

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)