GORE EXCLUDER AAA Endoprosthesis PXA230300Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00733132609871), received between Sep 17, 2018 and Feb 9, 2024 — classified as 1 death, 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 9, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2013, THIS PATIENT UNDERWENT AN ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESES. AN AORTIC EXTENDER ENDOPROSTHESIS WAS IMPLANTED PROXIMALLY AND A CONTRALATERAL LEG ENDOPROSTHESIS WAS IMPLANTED ON THE RIGHT SIDE. ON AN UNKNOWN DATE, ENLARGEMENT OF THE ANEURYSM DUE TO A PROXIMAL TYPE I ENDOLEAK AND A RIGHT DISTAL TYPE I ENDOLEAK WAS OBSERVED. REPORTEDLY, THE TREND OF ANEURYSMAL ENLARGEMENT BECAME MORE PRONOUNCED ABOUT 3 YEARS AGO. ON (B)(6) 2024, A REINTERVENTION WAS PERFOMED. AN ADDITIONAL STENT GRAFT WAS IMPLANTED PROXIMALLY. ALSO, AN ADDITIONAL STENT GRAFT WAS IMPLANTED TO EXTEND TO THE RIGHT EXTERNAL ILIAC ARTERY AFTER EMBOLIZATION OF THE RIGHT INTERNAL ILIAC ARTERY. ANGIOGRAPHY CONFIRMED NO ENDOLEAK AND THE PROCEDURE WAS COMPLETED. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Aneurysm expansion; Clinical Endoleak

  MAUDE report 18674403 ↗
• InjuryOct 4, 2021Migration; Migration

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2011, A PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESIS. PXA230300 WAS IMPLANTED DISTALLY IN THE LEFT LEG. ON UNKNOWN DATE, AT A FOLLOW-UP, AN ENLARGEMENT OF A LEFT COMMON ILIAC ARTERY WAS OBSERVED, LEADING TO A MIGRATION OF THE STENT GRAFT TO DISTAL. ON (B)(6) 2021, REINTERVENTION WAS PERFORMED. LEFT INTERNAL ILIAC ARTERY WAS EMBOLIZED USING COIL. PLC141400J WAS IMPLANTED FROM THE FLOW DIVIDER AND PLA121400J WAS IMPLANTED TO EXTEND TO A LEFT INTERNAL ILIAC ARTERY. THE PATIENT TOLERATED THE PROCEDURE. THE PHYSICIAN STATED THAT IT HAD BEEN TEN YEARS SINCE THE INITIAL TREATMENT, THIS EVENT OCCURRED AS AN INEVITABLE.

  Patient problems: Aneurysm

  MAUDE report 12568061 ↗
• InjurySep 1, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2007, THE PATIENT WAS IMPLANTED WITH A GORE® EXCLUDER® AAA ENDOPROSTHESES TO TREAT AN ABDOMINAL AORTIC ANEURYSM. THE PATIENT TOLERATED THE PROCEDURE. IT WAS REPORTED THAT ANGIOGRAM IMAGES, DATED (B)(6) 2021, REVEALED A POSSIBLE PROXIMAL TYPE I ENDOLEAK. IT IS UNKNOWN IF THERE WAS ANEURYSM SAC ENLARGEMENT. ON (B)(6) 2021 THERE WAS A REINTERVENTION. THE PHYSICIAN IMPLANTED A GORE® EXCLUDER® AAA ENDOPROSTHESIS AORTIC EXTENDER IN THE PROXIMAL SEAL ZONE FROM THE ORIGINAL PROCEDURE. THE ENDOLEAK WAS RESOLVED. THE PATIENT TOLERATED THE REINTERVENTION PROCEDURE.

  Patient problems: Aneurysm

  MAUDE report 12411554 ↗
• InjuryJul 21, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  ON (B)(6) 2009, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM USING A GORE¿ EXCLUDER¿ AAA ENDOPROSTHESIS. ON AN UNKNOWN DATE, FOLLOW-UP EXAMINATION REPORTEDLY REVEALED A SUSPECTED TYPE IA ENDOLEAK. THE CAUSE OF THE SUSPECTED ENDOLEAK WAS NOT REPORTED. IT WAS UNKNOWN WHETHER ANEURYSM ENLARGEMENT WAS PRESENT. ON (B)(6) 2021, THE PATIENT UNDERWENT A REINTERVENTION PROCEDURE WHEREBY AN ADDITIONAL STENT GRAFT WAS DEPLOYED TO EXTEND THE DEVICE PROXIMALLY. NO ENDOLEAK WAS OBSERVED ON FINAL PROCEDURAL ANGIOGRAPH. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 12203357 ↗
• InjuryFeb 28, 2020Patient-Device Incompatibility; Patient-Device Incompatibility

  FOLLOWING WAS REPORTED TO GORE. ON (B)(6) 2011, A PATIENT UNDERWENT A TREATMENT OF DISSECTION OF THE DESCENDING AORTA WITH GORE® EXCLUDER® AAA ENDOPROSTHESIS AND GORE® TAG® THORACIC ENDOPROSTHESIS. TWO AORTIC EXTENDER COMPONENT (PXA230300) WERE PLACED FOLLOWED BY A TAG (TGT2815). THE PROCEDURE WAS COMPLETED WITHOUT ANY ISSUES. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2016, A FOLLOW UP IMAGE REVEALED THE ANEURYSM DIAMETER WAS 50MM. ON AN UNKNOWN DATE, A FOLLOW UP IMAGE REVEALED DISTAL TYPE I ENDOLEAK AT THE DISTAL END OF ONE OF THE TWO AORTIC EXTENDER ENDOPROSTHESIS (EXACT LOCATION IS UNKNOWN), AND THE ANEURYSM DIAMETER MEASURED TO BE 55MM. ON (B)(6) 2020, A REINTERVENTION WAS PERFORMED TO TREAT THE ENDOLEAK. A TGM343415 WAS PLACED AT THE DISTAL SIDE OF ONE OF THE TWO AORTIC EXTENDER ENDOPROSTHESIS, TO RIGHT ABOVE THE CELIAC ARTERY. FINAL ANGIOGRAPHY REVEALED NO ENDOLEAK, AND THE PROCEDURE WAS COMPLETED. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Aneurysm

  MAUDE report 9770999 ↗
• DeathSep 17, 2018Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  ON AN UNKNOWN DATE, THE PATIENT UNDERWENT TREATMENT OF A RUPTURED ABDOMINAL AORTIC ANEURYSM WITH GORE® EXCLUDER® AAA ENDOPROSTHESES. THREE 23 MM AORTIC EXTENDER COMPONENTS (PXA230300J/ LOT NUMBERS UNKNOWN) WERE IMPLANTED JUST ABOVE THE AORTIC BIFURCATION. THE DIAMETER OF THE INFRARENAL AORTA WAS A REPORTED 17-18 MM. THE PATIENT TOLERATED THE PROCEDURE. APPROXIMATELY FOUR MONTHS LATER, ON UNKNOWN DATE, THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR ABDOMINAL PAIN, BLACK STOOL AND ANEMIA. AN ENDOSCOPY SHOWED AN IRREGULAR FORMED TUMOR MASS WITH BLEEDING IN THE DUODENUM. A BIOPSY WAS PERFORMED, AND IGG4-RELATED DISEASE WAS SUSPECTED. A COMPUTED TOMOGRAPHY SCAN INDICATED THE AORTA HAD BEEN ENLARGED (SIZE UNKNOWN) AT THE REGION WHERE THE DEVICES WERE IMPLANTED. NO ENDOLEAK WAS OBSERVED. THE PATIENT WAS ADMINISTERED MEDICATION (PROTON PUMP INHIBITOR AND IRON) AS A CONSERVATIVE MEDICAL TREATMENT, AND DISCHARGED FROM THE HOSPITAL REPORTEDLY HAVING SHOWN IMPROVEMENT. ONE MONTH LATER, ON UNKNOWN DATE, THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR BLEEDING. THE PATIENT REPORTEDLY EXPIRED OF HEMORRHAGIC SHOCK DUE TO SEVERE MELENA. AN AUTOPSY WAS PERFORMED AND AN AORTO-DUODENAL FISTULA WAS CONFIRME

  Patient problems: Death; Fistula

  MAUDE report 7881579 ↗

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