GORE EXCLUDER AAA Endoprosthesis PXT281218Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00733132610280), received between Aug 20, 2018 and Oct 21, 2022 — classified as 7 injuries.

The most frequently reported specific device problem is “Lack of Effect” (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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryOct 21, 2022Adverse Event Without Identified Device or Use Problem; Lack of Effect; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2008, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT USING GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS. ON AN UNKNOWN DATE, ANEURYSM ENLARGEMENT WAS OBSERVED. ON (B)(6) 2022, THE PATIENT UNDERWENT REINTERVENTION. A BYPASS WAS CONSTRUCTED FROM THE LEFT INTERNAL ILIAC ARTERY TO THE EXTERNAL ILIAC ARTERY AND AN ADDITIONAL STENT GRAFT WAS DEPLOYED. THE CAUSE OF ANEURYSM ENLARGEMENT HAS NOT BEEN REPORTED.

  Patient problems: Aneurysm expansion

  MAUDE report 15651929 ↗
• InjuryJun 30, 2020Migration; Migration

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2012, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM USING A GORE® EXCLUDER® AAA ENDOPROSTHESIS. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2013, THE PATIENT UNDERWENT THE REINTERVENTION FOR A DISTAL TYPE I ENDOLEAK OF THE RIGHT LEG. THE RIGHT INTERNAL ILIAC ARTERY WAS EMBOLIZED AND AN ILIAC EXTENDER ENDOPROSTHESIS WAS IMPLANTED TO THE RIGHT EXTERNAL ILIAC ARTERY. (CAPTURED IN #(B)(4)) ON AN UNKNOWN DATE IN 2020, THE FOLLOW-UP EXAM SHOWED A DISTAL TYPE I ENDOLEAK OF AN IPSILATERAL LEG OF THE TRUNK IPSILATERAL LEG ENDOPROSTHESIS (LEFT LEG) DUE TO THE MIGRATION OF THE IPSILATERAL LEG INTO THE ANEURYSM SAC. ON (B)(6) 2020, A CONTRALATERAL LEG ENDOPROSTHESIS WAS IMPLANTED IN THE LEFT COMMON ILIAC ARTERY, DISTAL OF THE IPSILATERAL LEG. AN INTRAOPERATIVE IMAGE IDENTIFIED A SUSPECTED TYPE II ENDOLEAK ORIGINATING FROM THE ILIOLUMBAR ARTERY. THE PHYSICIAN DECIDED TO MONITOR IT. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Aneurysm

  MAUDE report 10212631 ↗
• InjuryApr 29, 2020Unintended Movement; Unintended Movement

  ON (B)(6) 2010, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM AND WAS IMPLANTED WITH GORE® EXCLUDER® AAA ENDOPROSTHESES. ON (B)(6) 2020, THE PATIENT PRESENTED EMERGENTLY AND UNDERWENT TREATMENT FOR A RUPTURE OF THE ANEURYSM CAUSED BY A TYPE III ENDOLEAK. IT WAS REPORTED THAT THE MAIN BODY (TRUNK IPSILATERAL LEG COMPONENT) HAD MIGRATED DISTALLY AND THERE WAS A DISCONNECT TO THE AORTIC EXTENDER COMPONENTS ORIGINALLY PLACED TO EXTEND COVERAGE. A GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM WAS PLACED TO SUCCESSFULLY TREAT AND RESOLVE THE TYPE III ENDOLEAK. THE PATIENT TOLERATED THE PROCEDURE. ADDITIONALLY, IT WAS REPORTED THAT THE PATIENT HAD BEEN MONITORED FOR A TYPE II ENDOLEAK WITH UNKNOWN ENLARGEMENT, BUT HAD NOT BEEN SEEN WITHIN THE PAST YEAR AND A HALF.

  Patient problems: Aneurysm

  MAUDE report 10009793 ↗
• InjuryDec 20, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING WAS REPORTED TO GORE. ON (B)(6) 2011, A PATIENT UNDERWENT A TREATMENT OF ABDOMINAL AORTIC ANEURYSM WITH GORE® EXCLUDER® AAA ENDOPROSTHESES. DURING THE PROCEDURE, GORE® EXCLUDER® AAA TRUNK-IPSILATERAL LEG ENDOPROSTHESIS AND CONTRALATERAL LEG ENDOPROSTHESIS WERE IMPLANTED. THE PATIENT TOLERATED THE PROCEDURE. ON A ROUTINE FOLLOW-UP, IMAGES (DATE IS UNKNOWN) REVEALED PROXIMAL AORTIC NECK ENLARGEMENT AND ANEURYSM ENLARGEMENT (AMOUNT UNKNOWN). ON (B)(6) 2019, TWO ADDITIONAL GORE® EXCLUDER® AORTIC EXTENDER ENDOPROSTHESES WERE IMPLANTED. THE PATIENT TOLERATED THE PROCEDURE. (IT WAS REPORTED ALTHOUGH THE LEFT RENAL ARTERY WAS PARTIALLY COVERED BY THE DEVICE, THERE WAS NO OBSTRUCTION OF BLOOD FLOW.) THE PHYSICIAN STATED THAT NO ENDOLEAK WAS CONFIRMED ON THE IMAGE OF THE CONTRAST ENHANCED COMPUTED TOMOGRAPHY (CT), HOWEVER, THE ANEURYSM ENLARGEMENT WAS PROBABLY CAUSED BY AN ENDOLEAK.

  Patient problems: Aneurysm

  MAUDE report 9504555 ↗
• InjuryJun 14, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2006, THE PATIENT WAS IMPLANTED WITH FIVE GORE® EXCLUDER® AAA ENDOPROSTHESES TO TREAT AN ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT COMPUTED TOMOGRAPHY (CT) IMAGES REVEALED, (DATE OF IMAGES IS UNKNOWN) THE PATIENT HAD A TYPE III ENDOLEAK, THE TRUNK-IPSILATERAL LEG ENDOPROSTHESIS MIGRATED DISTAL AND SEPARATED FROM THE AORTIC EXTENDER ENDOPROSTHESIS. THE REASON FOR THE ENDOLEAK IS A COMPONENT DISCONNECT BETWEEN THE PXT281218/04175114 AND PXA280300/03640548 DEVICES. THE PHYSICIAN REINTERVENED AND EXPLANTED THE GORE® EXCLUDER® AAA ENDOPROSTHESES AND PERFORMED A SURGICAL CONVERSION. THE PATIENT TOLERATED THE PROCEDURE. IT IS UNKNOWN IF ALL IMPLANTED DEVICES (IMPLANTED BUT NOT INVOLVED IN TYPE III ENDOLEAK PXC141400/03760286, PXC141000/04002548, AND PXC141400/04246109) WERE EXPLANTED.

  Patient problems: Aneurysm

  MAUDE report 8700835 ↗
• InjuryAug 27, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2010, THE PATIENT WAS IMPLANTED WITH GORE® EXCLUDER® AAA ENDOPROSTHESES TO TREAT AN ABDOMINAL AORTIC ANEURYSM. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2018, A FOLLOW-UP COMPUTED TOMOGRAPHY IMAGES REVEALED A PROXIMAL TYPE I ENDOLEAK. NO ANEURYSM SAC ENLARGEMENT WAS REPORTED. IT WAS REPORTED THAT ON (B)(6) 2018, THE PHYSICIAN REINTERVENED. THE PATIENT TOLERATED THE REINTERVENTION.

  Patient problems: Aneurysm

  MAUDE report 7818247 ↗
• InjuryAug 20, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  ON (B)(6) 2013, THE PATIENT UNDERWENT TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM WITH GORE® EXCLUDER® AAA ENDOPROSTHESES. PXT281218/(B)(4) , PXC121400/(B)(4) AND PXA280300 WERE IMPLANTED IN THE LEFT SIDE. AN ENDURANT LEG COMPONENT (MEDTRONIC) WAS IMPLANTED IN THE RIGHT SIDE. ON UNKNOWN DATE IN (B)(6) 2018, A ROUTINE FOLLOW-UP COMPUTED TOMOGRAPHY SCAN IDENTIFIED THAT THERE WAS NO ENDOLEAK. ON (B)(6) 2018, THE PATIENT UNDERWENT A TREATMENT OF A THORACIC AORTIC ANEURYSM WITH CONFORMABLE GORE TAG® THORACIC ENDOPROSTHESES. A PRE-OPERATIVE COMPUTED TOMOGRAPHY SCAN DETERMINED A TYPE III ENDOLEAK FROM THE JUNCTION OF THE PREVIOUSLY IMPLANTED ENDOPROSTHESES, THE PXT281218 AND THE PXC121400. AN ADDITIONAL ENDOPROSTHESIS WAS IMPLANTED IN THE LEFT LEG TO TREAT THE TYPE III ENDOLEAK. THE ENDOLEAK WAS RESOLVED. THE PATIENT TOLERATED THE PROCEDURE. THE PHYSICIAN STATED THAT HE SUSPECTED A JUNCTION LEAK FIRST, BUT THE PRE-OPERATIVE COMPUTED TOMOGRAPHY SCAN AND AN INTRA-OPERATIVE DSA INDICATED THAT THE ENDOLEAK WAS LIKELY A FABRIC LEAK OF THE PXT281218.

  Patient problems: Aneurysm

  MAUDE report 7800050 ↗

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)