GORE EXCLUDER AAA Endoprosthesis PXT231418Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00733132610167), received between Sep 6, 2018 and Aug 27, 2024 — classified as 6 injuries.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (3 reports).

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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryAug 27, 2024Patient-Device Incompatibility; Device-Device Incompatibility; Patient-Device Incompatibility; Device-Device Incompatibility

  ON (B)(6) 2013, THIS PATIENT UNDERWENT AN ENDOVASCULAR TREATMENT FOR ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESIS. ON AN UNKNOWN DATE, ANEURYSM ENLARGEMENT WAS NOTED. APPROXIMATELY TWO YEARS BEFORE THE TIME OF REPORTING, THE PATIENT RECEIVED EMBOLIZATION OF THE INFERIOR MESENTERIC ARTERY FOR A TYPE II ENDOLEAK. (THIS EVENT HAS BEEN SEPARATELY REPORTED IN REPORT# 2953161-2024-01215). ON (B)(6) 2024, A FOLLOW-UP CT SCAN SHOWED FURTHER ANEURYSM ENLARGEMENT AND A SUSPECTED TYPE IB ENDOLEAK ON THE RIGHT SIDE. AN ADDITIONAL TREATMENT WAS INDICATED. ON (B)(6) 2024, PRELIMINARY EMBOLIZATION OF THE RIGHT INTERNAL ILIAC ARTERY WAS PERFORMED. AN ANGIOGRAPHY DURING PROCEDURE SHOWED ANOTHER TYPE OF ENDOLEAK (SUSPECTED TYPE IA, TYPE IIIA OR TYPE IIIB). ON (B)(6) 2024, A REINTERVENTION WAS PERFORMED. AN AORTIC EXTENDER WAS PLACED AT THE PROXIMAL SIDE AND A CONTRALATERAL LEG WAS PLACED AT THE RIGHT DISTAL SIDE AND CONNECTION SITE OF THE PREVIOUS DEVICES. ALSO, ANOTHER CONTRALATERAL LEG WAS PLACED ON THE LEFT SIDE TO RELINE THE PREVIOUS IPSILATERAL LEG JUST IN CASE. THERE WAS NO MORE OBVIOUS ENDOLEAKS. THE PATIENT TOLERATED THE PROCEDURE. THE REPORTING PHYSICIAN COMMENTED AS F

  Patient problems: Aneurysm expansion; Clinical Endoleak

  MAUDE report 20073260 ↗
• InjuryAug 27, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  ON (B)(6) 2013, THIS PATIENT UNDERWENT AN ENDOVASCULAR TREATMENT FOR ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESIS. ON AN UNKNOWN DATE, ANEURYSM ENLARGEMENT WAS NOTED. APPROXIMATELY TWO YEARS BEFORE THE TIME OF REPORTING, THE PATIENT RECEIVED EMBOLIZATION OF THE INFERIOR MESENTERIC ARTERY FOR A TYPE II ENDOLEAK. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Aneurysm expansion; Clinical Endoleak

  MAUDE report 20073238 ↗
• InjuryMay 3, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2009, A PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESES. A LEG OF DEVICE, PXT231418, WAS IMPLANTED IN THE LEFT SIDE. ON UNKNOWN DATE, AT A PERIODIC FOLLOW UP, A DISTAL TYPE I ENDOLEAK AT A LEFT SIDE WAS OBSERVED. ON (B)(6) 2023, A REINTERVENTION WAS PERFORMED. AN INTERNAL ILIAC ARTERY WAS EMBOLIZED. A STENT GRAFT WAS IMPLANTED TO EXTEND INTO AN EXTERNAL ILIAC ARTERY. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Clinical Endoleak

  MAUDE report 16860144 ↗
• InjurySep 21, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2012, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESES. IT WAS REPORTED THAT AFTER ALL DEVICES WERE IMPLANTED, A DISTAL TYPE I ENDOLEAK FROM THE CONTRALATERAL LEG ENDOPROSTHESIS IN THE RIGHT LIMB WAS OBSERVED. A STENT (PALMAZ) WAS IMPLANTED DISTALLY OF THE CONTRALATERAL LEG ENDOPROSTHESIS. HOWEVER THE DISTAL TYPE I ENDOLEAK REMAINED. THE PHYSICIAN DECIDED TO MONITOR IT. ON AN UNKNOWN DATE IN (B)(6) 2020, A FOLLOW-UP CT IMAGING IDENTIFIED THE DISTAL TYPE I ENDOLEAK FROM THE RIGHT LEG REMAINED AND MIGRATION (DISTANCE UNKNOWN) OF THE TRUNK IPSILATERAL LEG ENDPROSTHESIS. ON (B)(6) 2020, A REINTERVENTION PROCEDURE WAS PERFORMED. THE RIGHT INTERNAL ILIAC ARTERY WAS EMBOLIZED AS PLANNED. THEN, AN ILIAC EXTENDER ENDOPROSTHESIS WAS IMPLANTED IN THE RIGHT EXTERNAL ILIAC ARTERY. TWO AORTIC EXTENDER ENDOPROSTHESES WERE IMPLANTED PROXIMAL OF THE TRUNK IPSILATERAL LEG ENDOPROSTHESIS. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Aneurysm

  MAUDE report 10564314 ↗
• InjuryDec 20, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  ON (B)(6) 2010, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM AND WAS IMPLANTED WITH GORE® EXCLUDER® AAA ENDOPROSTHESES. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2019, FOLLOW-UP IMAGING DETERMINED ANEURYSM ENLARGEMENT. THE PATIENT WAS ALSO REPORTED TO HAVE A TYPE I PROXIMAL ENDOLEAK. A REINTERVENTION IS NOT YET SCHEDULED, BUT IS PLANNED.

  Patient problems: Aneurysm

  MAUDE report 9501023 ↗
• InjurySep 6, 2018Patient-Device Incompatibility; Patient-Device Incompatibility

  ON (B)(6) 2009, THE PATIENT UNDERWENT ENDOVASCULAR REPAIR OF AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESES. AFTER TRUNK-IPSILATERAL LEG AND CONTRALATERAL LEG COMPONENTS (PXT231418/06551039 AND PXC141400/06603644) WERE DEPLOYED, AORTIC EXTENDER AND ILIAC EXTENDER COMPONENTS (PXL161007/06772203 AND PXA230300/06501919) WERE IMPLANTED FOR PROXIMAL AND DISTAL EXTENSION OF THE ENDOPROSTHESES. THE PROCEDURE WAS SUCCESSFULLY CONCLUDED WITHOUT ENDOLEAKS. IN 2012, ANEURYSM ENLARGEMENT WAS REVEALED DUE TO A SUSPECTED TYPE II ENDOLEAK ORIGINATING FROM A LUMBAR ARTERY. EXACT AMOUNT OF ENLARGEMENT WAS REPORTEDLY UNKNOWN. A REINTERVENTION WAS PERFORMED WHEREBY AN AORTIC EXTENDER COMPONENT WAS IMPLANTED AND THE ANEURYSM WAS EMBOLIZED USING N-BUTYL-2-CYANOACRYLATE (NBCA). ANOTHER FOLLOW-UP STUDY WAS PERFORMED AFTER THE REINTERVENTION, CONFIRMING THAT THE ANEURYSM HAD CONTINUED TO EXPAND (EXACT AMOUNT OF ENLARGEMENT WAS UNKNOWN). THE PATIENT HAS CURRENTLY BEEN MONITORED WITH ANEURYSM ENLARGEMENT.

  Patient problems: Aneurysm

  MAUDE report 7849816 ↗

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