GORE EXCLUDER AAA Endoprosthesis PXT231214Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00733132610105), received between Mar 30, 2021 and Feb 17, 2023 — classified as 3 injuries.

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 17, 2023Migration; Migration

  ON (B)(6) 2011, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESES. ON AN UNKNOWN DATE IN 2022, CT EXAMINATION CONFIRMED DISTAL MIGRATION OF THE MAIN DEVICE WITH ANEURYSM ENLARGEMENT. ON (B)(6) 2023, REINTERVENTION WAS PERFORMED. INTRAOPERATIVE ANGIOGRAPHY DID NOT SHOW A PROXIMAL TYPE I ENDOLEAK. AS A TREATMENT FOR THE DEVICE MIGRATION WITH ANEURYSM ENLARGEMENT, CHIMNEY STENTGRAFT WAS IMPLANTED INTO THE LEFT RENAL ARTERY AND AN AORTIC EXTENDER WAS ADDITIONALLY IMPLANTED IN THE PROXIMAL SIDE. THE PATIENT TOLERATED THE PROCEDURE. REPORTEDLY THE MIGRATION WAS DUE TO AGING/DISEASE PROGRESSION.

  Patient problems: Aneurysm expansion

  MAUDE report 16395823 ↗
• InjuryNov 17, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2007, THIS PATIENT UNDERWENT AN ENDOVASCULAR TREATMENT FOR AN 45MM ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESES. THE TRUNK-IPSILATERAL LEG ENDOPROSTHESIS WAS IMPLANTED FROM THE RIGHT SIDE. THE CONTRALATERAL LEG AND AN ILIAC EXTENDER WERE PLACED FROM THE LEFT SIDE. A COVERED STENT (ATRIUM ADVANTA V12, 6 MM X 38 MM) WAS IMPLANTED IN THE RIGHT INTERNAL ILIAC ARTERY. AT A FOLLOW UP ON AN UNKNOWN DATE, THE ANEURYSM SAC SIZE MEASURED 24 MM. IN 2016, FOLLOW UP SHOWED ANEURYSM ENLARGEMENT. ON AN UNKNOWN DATE IN (B)(6) 2021, THE ANEURYSM MEASURED 55 MM AND AN ADDITIONAL PROCEDURE WAS INDICATED. ON (B)(6) 2021, ANGIOGRAPHY WAS PERFORMED AS A TYPE II ENDOLEAK OR DISTAL TYPE I ENDOLEAK FROM THE RIGHT SIDE WAS SUSPECTED. THE ANGIOGRAM SHOWED A DISTAL TYPE I ENDOLEAK BUT TYPE II ENDOLEAK WAS NOT OBVIOUS. TO RESOLVE THE DISTAL TYPE I ENDOLEAK, THE RIGHT INTERNAL ILIAC ARTERY WAS EMBOLIZED AND AN ADDITIONAL ILIAC EXTENDER ENDOPROSTHESIS (PLL161207J) WAS IMPLANTED INTO THE RIGHT COMMON ILIAC ARTERY. THE TREATMENT AREA WAS EXTENDED TO THE EXTERNAL ILIAC ARTERY. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Aneurysm

  MAUDE report 12830672 ↗
• InjuryMar 30, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2011, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESIS. NO ISSUES WERE OBSERVED DURING THE PROCEDURE. ON AN UNKNOWN DATE, FOLLOW-UP EXAM IDENTIFIED ANEURYSM ENLARGEMENT (AMOUNT UNKNOWN). THE CAUSE OF THE ENLARGEMENT WAS REPORTEDLY A SUSPECTED PROXIMAL TYPE I ENDOLEAK, DISTAL TYPE I ENDOLEAK FROM THE RIGHT LEG (IPSILATERAL SIDE), OR TYPE II ENDOLEAK ORIGINATING FROM LUMBER ARTERIES. ON (B)(6) 2021, ADDITIONAL STENT GRAFTS WERE IMPLANTED TO EXTEND THE PROXIMAL NECK AND RIGHT LEG. COIL EMBOLIZATION WAS ALSO PERFORMED TO THE LUMBER ARTERIES. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Aneurysm

  MAUDE report 11592834 ↗

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)