GORE EXCLUDER AAA Endoprosthesis PXT261214Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00733132610181), received between Mar 20, 2019 and Jun 9, 2020 — classified as 3 injuries.

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

• InjuryJun 9, 2020Patient-Device Incompatibility; Patient-Device Incompatibility

  ON (B)(6) 2011, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESES. THE TREATMENT WAS COMPLETED WITHOUT ANY ISSUES AFTER PLACING PXT261214 FROM THE RIGHT SIDE AND PXC141400 IN THE LEFT SIDE OF THE PATIENT. IN (B)(6) 2012 (DATE IS UNKNOWN), THE FOLLOW-UP EXAMINATION SHOWED NO ANOMALIES. THE ANEURYSM DIAMETER WAS APPROXIMATELY 41 X 43 MM. IN (B)(6) 2018 (DATE IS UNKNOWN), THE FOLLOW-UP EXAMINATION SHOWED NO CHANGE IN THE ANEURYSM SIZE. IN (B)(6) 2019 (DATE IS UNKNOWN), THE FOLLOW-UP EXAMINATION SHOWED ANEURYSM ENLARGEMENT. THE DIAMETER WAS APPROXIMATELY 45 X 51 MM. IN (B)(6) 2020 (DATE IS UNKNOWN), A FOLLOW-UP EXAMINATION REVEALED THAT THE ANEURYSM DIAMETER EXPANDED TO 54 X 58 MM. BASED ON COMPUTED TOMOGRAPHY (CT), NO OBVIOUS ENDOLEAK WAS IDENTIFIED. ON (B)(6) 2020, ADDITIONAL TREATMENT WAS PERFORMED. AS THE LANDING ZONES OF THE PROXIMAL NECK OF THE MAIN BODY AND THE DISTAL NECK OF THE RIGHT LEG WERE SLIGHTLY SHORT, PROXIMAL AND DISTAL TYPE I ENDOLEAKS WERE SUSPECTED. HOWEVER, NO ENDOLEAK WAS IDENTIFIED BY ANGIOGRAPHY. AS A PREVENTION, STENTGRAFTS WERE ADDITIONALLY IMPLANTED BOTH IN THE PROXIMAL AND THE DISTAL TO THE

  Patient problems: Aneurysm

  MAUDE report 10135766 ↗
• InjuryApr 2, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2009 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 (DATE AND MODALITY OF IMAGES IS UNKNOWN). THERE IS ANEURYSM SAC ENLARGEMENT REPORTED (AMOUNT IS UNKNOWN). THE CAUSE FOR THE TYPE I ENDOLEAK IS UNKNOWN. ON (B)(6) 2020, THE PHYSICIAN REINTERVENED AND IMPLANTED A GORE® EXCLUDER® AORTIC EXTENDER ENDOPROSTHESIS PROXIMALLY AND ILIAC EXTENDER ENDOPROSTHESES BILATERALLY DISTALLY. THE PHYSICIAN WANTED FURTHER DISTAL COVERAGE IN BOTH COMMON ILIAC ARTERIES. THE ENDOLEAK WAS RESOLVED AT THE END OF THE CASE. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Aneurysm

  MAUDE report 9919007 ↗
• InjuryMar 20, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2010, THE PATIENT UNDERWENT ENDOVASCULAR REPAIR OF AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESES. IT WAS REPORTED THAT, ON AN UNKNOWN DATE, A COMPUTERIZED TOMOGRAPHY SCAN IDENTIFIED ANEURYSM ENLARGEMENT. REPORTEDLY THE AMOUNT OF ANEURYSM ENLARGEMENT IS UNKNOWN. THE PHYSICIAN PERFORMED AN ANGIOGRAM IN ORDER TO DETERMINE THE CAUSE OF THE ANEURYSM ENLARGEMENT. THE CAUSE OF THE ENLARGEMENT WAS UNABLE TO BE DETERMINED, AND NO ENDOLEAKS WERE IDENTIFIED. THE PHYSICIAN NOTED THAT THE PREVIOUSLY IMPLANTED CONTRALATERAL LEG COMPONENT (LOT #7758597) APPEARED TO BE, "SITTING LOW," IN THE GATE OF THE TRUNK-IPSILATERAL LEG COMPONENT (LOT #06809135). IT WAS REPORTED THAT ON (B)(6) 2019 A REINTERVENTION WAS PERFORMED AS A PRECAUTIONARY MEASURE TO ATTEMPT TO TEAT THE UNIDENTIFIED ANEURYSM ENLARGEMENT. REPORTEDLY A CONTRALATERAL LEG COMPONENT WAS USED AS A BRIDGING MECHANISM BETWEEN THE PREVIOUSLY IMPLANTED CONTRALATERAL AND TRUNK-IPSILATERAL LEG COMPONENTS. THERE WERE NO FURTHER REPORTED ISSUES. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Aneurysm

  MAUDE report 8438775 ↗

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)