GORE EXCLUDER AAA Endoprosthesis PXT231218Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00733132610129), received between Sep 4, 2019 and Jul 5, 2023 — classified as 7 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryJul 5, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2010, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT USING GORE® EXCLUDER® AAA ENDOPROSTHESIS FOR AN ABDOMINAL AORTIC ANEURYSM. ON AN UNKNOWN DATE, REGULAR FOLLOW-UP REVEALED COMMON ILIAC ARTERY DILATATION AND DISTAL TYPE I ENDOLEAK. OF THE 3 DEVICES THAT WERE IMPLANTED DURING INITIAL PROCEDURE IT IS UNKNOWN WHICH ONE WAS RELATED TO THE DISTAL TYPE I ENDOLEAK. ON (B)(6) 2023, THE PATIENT UNDERWENT REINTERVENTION. REPORTEDLY, AN ADDITIONAL STENT GRAFT WAS PLACED.

  Patient problems: Clinical Endoleak

  MAUDE report 17262482 ↗
• InjuryMay 15, 2022Migration; Migration

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2013, THIS PATIENT UNDERWENT AN ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM AND RIGHT COMMON ILIAC ARTERIAL ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESES. THE PATIENT TOLERATED THE PROCEDURE. DURING THE FOLLOW-UP PERIOD, NEW ANEURYSMS WERE FORMED IN THE LEFT COMMON ILIAC AND INTERNAL ILIAC ARTERIES. THEREFORE, AN ADDITIONAL PROCEDURE WAS INDICATED FOR A POSSIBLE TYPE IB ENDOLEAK. ON (B)(6) 2022, GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESES (IBE) WERE ADDITIONALLY IMPLANTED INTO THE LEFT ILIAC ARTERY. THE ILIAC BRANCH COMPONENT WAS DEPLOYED WITHOUT PROBLEMS. TWO INTERNAL ILIAC COMPONENTS WERE PLACED IN THE INTERNAL ILIAC ARTERY; HOWEVER, TYPE IB ENDOLEAK WAS FOUND AND THE INTERNAL ILIAC ARTERY WAS EMBOLIZED EVENTUALLY. DURING THE ADDITIONAL PROCEDURE, IT WAS FOUND THAT THE PROXIMAL END OF THE TRUNK-IPSILATERAL LEG WHICH IMPLANTED IN THE INITIAL PROCEDURE WAS A LITTLE BIT MIGRATED DISTALLY THOUGH NO TYPE IA ENDOLEAK WAS NOTED. THEREFORE, AN AORTIC EXTENDER WAS ALSO ADDITIONALLY IMPLANTED INTO THE AORTIC NECK TO PREVENT POTENTIAL TYPE IA ENDOLEAK. THE FINAL ANGIOGRAPHY SHOWED NO ENDOLEAK. THE PATIENT TOLERATED TH

  Patient problems: Aneurysm

  MAUDE report 14403804 ↗
• InjuryApr 9, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2005, THE PATIENT WAS IMPLANTED WITH GORE® EXCLUDER® AAA ENDOPROSTHESES TO TREAT AN ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT THE PATIENT HAD A PROXIMAL TYPE I ENDOLEAK AND THE GRAFT MIGRATED DISTALLY (DATE AND MODALITY OF IMAGES IS UNKNOWN, AMOUNT OF MIGRATION IS UNKNOWN) AND THE RIGHT IMPLANTED CONTRALATERAL LEG ENDOPROSTHESIS HAD MIGRATED PROXIMALLY INTO THE ANEURYSM SAC (AMOUNT OF MIGRATION IS UNKNOWN). THERE IS ANEURYSM SAC ENLARGEMENT (APPROXIMATELY 26-30MM). A REINTERVENTION OCCURRED ON (B)(6) 2021, A COOK FENESTRATED GRAFT WAS UTILIZED AND PULLED UP THE EXCLUDER ENDOPROSTHESIS. THE RIGHT HYPOGASTRIC ARTERY WAS EMBOLIZED AND AN ADDITIONAL CONTRALATERAL LEG ENDOPROSTHESIS WAS IMPLANTED TO EXTEND INTO THE RIGHT EXTERNAL ILIAC ARTERY. A CONTRALATERAL LEG ENDOPROSTHESIS WAS IMPLANTED IN EACH ILIAC ARTERY TO EXTEND BOTH SIDES OF THE IMPLANTED ENDOPROSTHESIS. IT IS UNKNOWN WHICH OF IMPLANTED CONTRALATERAL LEG ENDOPROSTHESIS DEVICES HAD MIGRATED. THE ENDOLEAK WAS RESOLVED AND THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Aneurysm

  MAUDE report 11646108 ↗
• InjuryDec 30, 2020Patient-Device Incompatibility; Patient-Device Incompatibility

  ON (B)(6) 2013, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESES. ON AN UNKNOWN DATE, ANEURYSM ENLARGEMENT (AMOUNT UNKNOWN) THAT WAS SUSPECTED TO BE DUE TO A PROXIMAL TYPE I AND TYPE II ENDOLEAK WAS NOTED. ON (B)(6) 2020 THE PATIENT UNDERWENT REINTERVENTION. EMBOLIC MATERIAL WAS INJECTED INTO THE ORIGIN OF THE TYPE II ENDOLEAK AT THE PATIENT'S LUMBAR ARTERY. A GORE® EXCLUDER® AAA AORTIC EXTENDER COMPONENT WAS USED TO EXTEND THE TRUNK-IPSILATERAL LEG COMPONENT PROXIMALLY. THERE WERE NO FURTHER REPORTED ISSUES. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Aneurysm

  MAUDE report 11095433 ↗
• InjuryJun 15, 2020Patient-Device Incompatibility; Patient-Device Incompatibility

  ON (B)(6) 2011 THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM, BILATERAL COMMON ILIAC ARTERY ANEURYSMS, AND A RIGHT INTERNAL ILIAC ARTERY ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESES. THE SIZE OF THE PATIENT'S RIGHT COMMON ILIAC ARTERY ANEURYSM WAS REPORTED AS ABOUT 40MM IN DIAMETER. THE IPSILATERAL LEG OF THE TRUNK-IPSILATERAL LEG COMPONENT WAS PLACED WITHIN THE PATIENT'S RIGHT EXTERNAL ILIAC ARTERY WITH A REPORTED 15-20MM LANDING ZONE. DUE TO AN ALLERGY TO CONTRAST MEDIUM, PATIENT FOLLOW-UP WAS REPORTEDLY PERFORMED BY ECHO EACH YEAR. THERE WAS NO REPORTED POSTOPERATIVE ANEURYSM ENLARGEMENT FOR THREE YEARS. AFTER THREE YEARS POSTOPERATION, THE PATIENT'S RIGHT COMMON ILIAC ARTERY ANEURYSM REPORTEDLY ENLARGED SLIGHTLY. NO OTHER ANEURYSMS WERE FOUND TO HAVE EXPANDED. NO ENDOLEAK WAS CONFIRMED BY ECHO. ON AN UNKNOWN DATE IN (B)(6) 2020, NON-CONTRAST CT REVEALED ENLARGEMENT OF THE PATIENT'S RIGHT COMMON ILIAC ARTERY ANEURYSM. ENLARGEMENT WAS REPORTED AS APPROXIMATELY 20MM FROM PREOPERATION. REPORTEDLY THE CAUSE OF THE ANEURYSM ENLARGEMENT IS UNKNOWN. IT WAS ALSO CONFIRMED THAT THE PATIENT'S RIGHT EXTERNAL ILIAC ARTERY LANDING ZONE WAS SHORTENED. THE P

  Patient problems: Aneurysm

  MAUDE report 10155055 ↗
• InjuryMay 28, 2020Component Incompatible; Adverse Event Without Identified Device or Use Problem; Component Incompatible; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2012, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM MEASURING APPROXIMATELY 45MM IN DIAMETER, AND WAS IMPLANTED WITH GORE® EXCLUDER® AAA ENDOPROSTHESIS. IN THE BEGINNING OF (B)(6) 2020, FOLLOW-UP IMAGING REVEALED ANEURYSM ENLARGEMENT TO APPROXIMATELY 60 MM IN DIAMETER AND A TYPE II ENDOLEAK FROM THE L4 LUMBAR ARTERY. ADDITIONALLY, A PROXIMAL TYPE I ENDOLEAK WAS DETERMINED ALONG WITH A TYPE III ENDOLEAK DUE TO COMPONENT DISCONNECT OF THE CONTRALATERAL LEG COMPONENT FROM THE CONTRALATERAL GATE. ON (B)(6) 2020, A REINTERVENTION WAS PERFORMED AND AN ENDURANT CUFF WAS PLACED TO TREAT THE PROXIMAL TYPE I ENDOLEAK, AND A CONTRALATERAL LEG COMPONENT WAS PLACED TO TREAT AND RELINE THE TYPE III ENDOLEAK. NO TREATMENT FOR THE TYPE II ENDOLEAK WAS PERFORMED BUT FUTURE TREATMENT IS PLANNED. THE TYPE I ENDOLEAK WAS REPORTED TO HAVE NOT BEEN RESOLVED BY PLACEMENT OF THE ENDURANT CUFF. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Aneurysm

  MAUDE report 10098773 ↗
• InjurySep 4, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  ON (B)(6) 2009, THE PATIENT WAS IMPLANTED WITH THREE GORE® EXCLUDER® AAA ENDOPROSTHESES TO TREAT AN ABDOMINAL AORTIC ANEURYSM. FINAL PROCEDURAL IMAGING REPORTEDLY IDENTIFIED PROXIMAL TYPE I AND TYPE II ENDOLEAKS. NO FURTHER TREATMENT WAS RENDERED AT THE TIME, AND THE PHYSICIAN MONITORED THE PATIENT. ON AN UNKNOWN DATE, A FOLLOW-UP EXAMINATION REPORTEDLY IDENTIFIED ANEURYSM ENLARGEMENT (AMOUNT AND CAUSE ARE UNKNOWN). ACCORDING TO THE REPORT, NO ENDOLEAKS WERE OBSERVED. ON (B)(6) 2019, THE PATIENT UNDERWENT A PROCEDURE WHEREBY THE ENDOPROSTHESES WERE EXPLANTED AND THE VASCULATURE WAS SURGICALLY REPAIRED. THE PATIENT TOLERANT THE PROCEDURE. IT WAS REPORTED THAT IT WAS NOT LIKELY THAT THE TYPE I, TYPE II, OR TYPE III ENDOLEAK LED TO ANEURYSM ENLARGEMENT. IT WAS ALSO REPORTED THAT NO RE-INTERVENTIONS WERE PERFORMED DURING THE TIME OF DEVICE IMPLANT.

  Patient problems: No Code Available

  MAUDE report 8961165 ↗

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)