GORE EXCLUDER AAA Endoprosthesis PXA260300Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00733132609888), received between Oct 5, 2018 and Dec 18, 2023 — classified as 5 injuries.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryDec 18, 2023Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem; Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2023, THIS PATIENT UNDERWENT AN ENDOVASCULAR TREATMENT FOR ABDOMINAL AORTIC ANEURYSM AND COMMON ILIAC ARTERY ANEURYSMS USING GORE® EXCLUDER® AAA ENDOPROSTHESES. ALL THE PLANNED DEVICES WERE IMPLANTED SUCCESSFULLY. CONSIDERING THE DIAMETER OF COMMON ILIAC ARTERIES (RIGHT 16 ¿ 22 MM, LEFT 16 - 22 MM), AORTIC EXTENDER COMPONENTS (RIGHT PXA280300, LEFT PXA260300) WERE IMPLANTED IN THE DISTAL END OF BILATERAL SIDES. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2023, A REINTERVENTION WAS PERFORMED AS LEFT COMMON ILIAC ANEURYSM ENLARGEMENT WAS FOUND. GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS (IBE) WAS PLANNED TO BE PLACED IN THE LEFT ILIAC ARTERY. PRIOR TO STARTING THIS REINTERVENTION, THE FSA NOTICED EVIDENCE FROM THE CT IMAGES THAT ANOTHER REINTERVENTION HAD BEEN PERFORMED ON THE RIGHT DISTAL SIDE AS WELL. IT APPEARED THAT AN ADDITIONAL STENT GRAFT HAD BEEN PLACED IN THE RIGHT SIDE TOO AFTER THE INITIAL PROCEDURE (TIMING AND REASON UNKNOWN). DURING THE REINTERVENTION ON (B)(6) 2023, THE ILIAC BRANCH COMPONENT (IBC) WAS SUCCESSFULLY DEPLOYED; HOWEVER, DELIVERY OF THE INTERNAL ILIAC COMPONENT (IIC) TO THE INTERNAL ILIAC ARTERY

  Patient problems: Aneurysm expansion

  MAUDE report 18352521 ↗
• InjuryMar 2, 2023Fluid/Blood Leak; Fluid/Blood Leak

  ON (B)(6) 2014, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM WITH A MAXIMUM DIAMETER OF 108MM AND WAS IMPLANTED WITH GORE® EXCLUDER® AAA ENDOPROSTHESES FEATURING C3® DELIVERY SYSTEM. THE PATIENT TOLERATED THE PROCEDURE AND WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2014. ON (B)(6) 2014, THE PATIENT UNDERWENT FOLLOW-UP COMPUTED TOMOGRAPHY WHICH DETERMINED THE MAXIMUM DIAMETER OF THE ANEURYSM MEASURED 92.3MM. ON (B)(6) 2019, IT WAS REPORTED THE PATIENT HAD DEVELOPED A RIGHT COMMON ILIAC ARTERY ANEURYSM (RCIA). ON (B)(6) 2022, COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) CHEST WITH AORTA ILIOFEMORAL RUNOFF SHOWED THE FOLLOWING: THE ABDOMINAL AORTIC ANEURYSM SAC MEASURES UP TO 8.2 X 4.9 CM IN MAXIMUM AXIAL DIMENSION AND APPEARS SIMILAR COMPARED TO ON (B)(6) 2019. THROMBUS WITHIN THE ANEURYSM SAC APPEARS SIMILAR TO PRIOR. SLIGHT INTERVAL INCREASE IN SIZE OF A 5.7 X 4.87 M RIGHT COMMON ILIAC ARTERY ANEURYSM ADJACENT TO THE DISTAL LIMB OF THE ENDOGRAFT COMPARED TO ON (B)(6) 2019. THERE IS THROMBUS WITHIN THE RIGHT EXTERNAL ILIAC ARTERY ANEURYSM. THERE IS ALSO A 6 MM SACCULAR ANEURYSM ARISING FROM THE POSTERIOR LEFT EXTERNAL ILIAC ARTERY WHICH IS SIMILAR COMPARED

  Patient problems: Aneurysm expansion

  MAUDE report 16475466 ↗
• InjuryAug 11, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2004, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESIS. ON (B)(6) 2021, FOLLOW UP EXAMINATION REVEALED TYPE 1 PROXIMAL ENDOLEAK FROM THE RIGHT COMMON ILIAC ARTERY. ON (B)(6) 2021 A REINTERVENTION TOOK PLACE TO TREAT THE ENDOLEAK. THE TYPE 1 PROXIMAL ENDOLEAK WAS IMPROVED, BUT WAS STILL SLIGHTLY PRESENT.

  Patient problems: Aneurysm

  MAUDE report 12308267 ↗
• InjuryJan 11, 2019Migration; Migration

  ON (B)(6) 2013, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM AND WAS IMPLANTED WITH FOUR GORE® EXCLUDER® AAA ENDOPROSTHESES FEATURING C3® DELIVERY SYSTEM. AN AORTIC EXTENDER ENDOPROSTHESIS WAS PLACED ON THE DISTAL END OF A CONTRALATERAL LEG ENDOPROSTHESIS IN THE LEFT COMMON ILIAC ARTERY. THE PATIENT TOLERATED THE PROCEDURE. ON AN UNKNOWN DATE IN 2016, A FOLLOW-UP IMAGING REPORTEDLY SHOWED THAT ONE OF THE CONTRALATERAL LEG ENDOPROSTHESIS IN THE LEFT COMMON ILIAC ARTERY MIGRATED APPROXIMATELY 5MM PROXIMALLY. ON AN UNKNOWN DATE IN (B)(6) 2018, IMAGING IDENTIFIED THE LEFT COMMON ILIAC ARTERY DIAMETER ENLARGEMENT. ON (B)(6) 2018, AN ADDITIONAL PROCEDURE WAS PERFORMED TO TREAT THE LEFT COMMON ILIAC ARTERY DIAMETER ENLARGEMENT. IT WAS REPORTED THAT THE LEFT INTERNAL ILIAC ARTERY WAS EMBOLIZED AND TWO CONTRALATERAL LEG ENDOPROSTHESES WERE IMPLANTED FROM THE LEFT COMMON ILIAC ARTERY TO THE LEFT EXTERNAL ILIAC ARTERY. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Aneurysm

  MAUDE report 8241034 ↗
• InjuryOct 5, 2018Patient-Device Incompatibility; Patient-Device Incompatibility

  ON (B)(6) 2011, THE PATIENT WAS IMPLANTED WITH A GORE® TAG® THORACIC ENDOPROSTHESIS TO TREAT A DISSECTING DESCENDING THORACIC AORTIC ANEURYSM. A GORE® EXCLUDER® AORTIC EXTENDER COMPONENT (PXA260300/8641521) WAS SEPARATELY IMPLANTED TO COVER AN ENTRY TEAR PROXIMAL TO THE CELIAC ARTERY. ON AN UNKNOWN DATE IN 2018, FOLLOW-UP EXAMINATION REPORTEDLY REVEALED THE FALSE LUMEN WAS ENLARGED AROUND THE AORTIC EXTENDER COMPONENT. ON (B)(6) 2018, A RE-INTERVENTION WAS PERFORMED WHEREBY AN ADDITIONAL CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESIS WAS IMPLANTED DISTALLY. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: No Code Available

  MAUDE report 7940531 ↗

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