GORE EXCLUDER AAA Endoprosthesis PXA280300Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00733132609895), received between Feb 18, 2019 and Dec 18, 2023 — classified as 6 injuries.

The most frequently reported specific device problem is “Human-Device Interface Problem” (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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

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

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2013, 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 18352425 ↗
• InjuryJul 14, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2011, THIS PATIENT WAS IMPLANTED WITH GORE®EXCLUDER®AAA ENDOPROSTHESES TO TREAT AN ABDOMINAL AORTIC ANEURYSM. ON (B)(6) 2011, COMPUTED TOMOGRAPHY (CT) SCAN REVEALED A PROXIMAL TYPE I ENDOLEAK. ON (B)(6) 2011, THE PATIENT UNDERWENT REINTERVENTION AND AN AORTIC EXTENDER COMPONENT WAS IMPLANTED TO TREAT THE ENDOLEAK. THE PATIENT TOLERATED THE PROCEDURE AND THE ENDOLEAK WAS RESOLVED. ON (B)(6) 2021, COMPUTED TOMOGRAPHY (CT) SCAN FOR A SUSPECTED PROXIMAL TYPE I ENDOLEAK. ON (B)(6) 2021, THE PATIENT UNDERWENT REINTERVENTION AND AN AORTIC EXTENDER COMPONENT WAS IMPLANTED TO TREAT THE ENDOLEAK. ANGIOGRAPHY AT THIS TIME DETERMINED THE ANEURYSM HAD ENLARGED TO 87MM HOWEVER, THE PROXIMAL TYPE I WAS UNABLE TO BE CONFIRMED. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Aneurysm

  MAUDE report 12170765 ↗
• InjuryMar 22, 2021Human-Device Interface Problem; Human-Device Interface Problem

  ON (B)(6) 2021, THIS PATIENT UNDERWENT REINTERVENTION FOR TREATMENT OF A PROXIMAL TYPE I ENDOLEAK. A GORE® AORTIC EXTENDER COMPONENT WAS PLACED PROXIMALLY TO EXTEND COVERAGE OF A PREVIOUSLY IMPLANTED GORE® AORTIC EXTENDER COMPONENT. ADDITIONALLY ENDOANCHORS WERE SCREWED IN TO OBTAIN SECURE TRANSMURAL FIXATION. THE PATIENT TOLERATED THE PROCEDURE AND THE ENDOLEAK WAS REDUCED BUT NOT FULLY RESOLVED.

  Patient problems: Aneurysm

  MAUDE report 11548072 ↗
• InjuryAug 2, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2013, A PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF ABDOMINAL AORTIC ANEURYSMS USING GORE® EXCLUDER® AAA ENDOPROSTHESES. ON AN UNKNOWN DATE, ENLARGEMENT OF THE ANEURYSM DIAMETER (AMOUNT UNKNOWN) AND A DISTAL TYPE I ENDOLEAK FROM THE LEFT LEG WERE NOTED. IT WAS CONFIRMED THAT THERE WAS LACK OF APPOSITION OF PXA280300/10067062 AT THE INNER CURVATURE OF THE PROXIMAL AORTIC NECK. ON (B)(6) 2020, RE-INTERVENTION WAS PERFORMED. DURING THE OPERATION, A PROXIMAL TYPE I ENDOLEAK WAS NOT IDENTIFIED, HOWEVER AN ADDITIONAL STENT GRAFT WAS IMPLANTED IN THE PROXIMAL NECK TO SOLVE THE LACK OF APPOSITION. THE PHYSICIAN COMMENTED THAT THE PROXIMAL NECK OF THE PATIENT WAS ANGLED, SO THE LACK OF APPOSITION IN THE PROXIMAL SIDE WAS CONSIDERED TO BE DUE TO THE PATIENT¿S ANATOMY.

  Patient problems: Aneurysm

  MAUDE report 10354254 ↗
• InjuryJun 29, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2012, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM AND WAS IMPLANTED WITH GORE® EXCLUDER® AAA ENDOPROSTHESIS FEATURING C3® DELIVERY SYSTEM. A GORE® AORTIC EXTENDER WAS PLACED AS THE MOST PROXIMAL DEVICE TO EXCLUDE COVERAGE OF THE TRUNK IPSILATERAL LEG COMPONENT. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2020, FOLLOW-UP IMAGING SHOWS WHAT APPEARS TO BE A PROXIMAL TYPE I ENDOLEAK. THE PHYSICIAN PLANS TO REINTERVENE TO PLACE AN ADDITIONAL AORTIC EXTENDER COMPONENT PROXIMALLY; BUT HAS NOT YET SCHEDULED A DATE. THERE WAS NO ANEURYSM ENLARGEMENT OR DEVICE MIGRATION REPORTED. THE CAUSE OF THE ENDOLEAK IS UNKNOWN.

  Patient problems: Aneurysm

  MAUDE report 10210059 ↗
• InjuryFeb 18, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE THROUGH THE GLOBAL REGISTRY FOR ENDOVASCULAR AORTIC TREATMENT (GREAT 10-11): ON (B)(6) 2014 A PATIENT WAS IMPLANTED WITH A GORE EXCLUDER AAA ENDOPROSTHESIS AORTIC EXTENDER COMPONENT AS A REINTERVENTION TO A PRIOR ENDOVASCULAR PROCEDURE. ON (B)(6) 2018, A REINTERVENTION OCCURRED WHEREBY A TRANSLUMBAR EMBOLIZATION WITH ONYX WAS PERFORMED TO TREAT A TYPE II ENDOLEAK. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Aneurysm

  MAUDE report 8348617 ↗

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