GORE EXCLUDER AAA Endoprosthesis PXT281414Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00733132610303), received between Dec 9, 2019 and Feb 20, 2024 — classified as 7 injuries.

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

• InjuryFeb 20, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2013, A PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESES. A TRUNK-IPSILATERAL LEG WAS IMPLANTED INTO A LEFT LEG. A CONTRALATERAL LEG WAS IMPLANTED INTO A RIGHT LEG. THE PATIENT TOLERATED THE PROCEDURE. ON UNKNOWN DATE, A DISTAL TYPE I ENDOLEAK AT THE RIGHT LEG WAS OBSERVED. ON UNKNOWN DATE, AN ANEURYSMATIC CHANGE (ENLARGEMENT) OF A LEFT COMMON ILIAC ARTERY WAS OBSERVED. ON (B)(6) 2024, A REINTERVENTION WAS PERFORMED. AN ANGIOGRAPHY REVEALED A DISTAL TYPE I ENDOLEAK AT THE LEFT COMMON ILIAC ARTERY. ONE STENT GRAFT WAS IMPLANTED TO EXTEND DISTALLY IN THE RIGHT LEG. TWO STENT GRAFTS WERE IMPLANTED TO EXTEND DISTALLY IN THE LEFT LEG. THE DISTAL TYPE I ENDOLEAK WAS RESOLVED. THE PATIENT TOLERATED THE PROCEDURE. THE PHYSICIAN STATED THAT THESE EVENTS WERE UNAVOIDABLE BECAUSE THE STENT GRAFTS ON BOTH SIDES WERE NOT PLACED DISTALLY ENOUGH.

  Patient problems: Aneurysm; Clinical Endoleak

  MAUDE report 18744951 ↗
• InjurySep 22, 2022Adverse 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, A PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM (51 MM X 60 MM) AND A RIGHT COMMON ILIAC ARTERY ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESES WITH COIL EMBOLIZATION OF A RIGHT INTERNAL ILIAC ARTERY. ON UNKNOWN DATE, AT A FOLLOW UP, A POSSIBLE TYPE II ENDOLEAK WAS OBSERVED. THE PHYSICIAN DECIDED TO MONITOR IT. ON (B)(6) 2018, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF A LEFT INTERNAL ILIAC ARTERY ANEURYSM USING A GORE® EXCLUDER® AAA ENDOPROSTHESIS WITH EMBOLIZATION OF THE LEFT INTERNAL ILIAC ARTERY AND A THORACIC AORTIC ANEURYSM USING ZENITH ALPHA. DURING THIS TREATMENT, A MINOR DIAMETER OF THE ABDOMINAL AORTIC ANEURYSM WAS 63 MM. ALSO, A POSSIBLE TYPE II ENDOLEAK WAS OBSERVED. THE PHYSICIAN DECIDED TO MONITOR IT. ON AN UNKNOWN DATE, AN ENLARGEMENT OF THE ABDOMINAL AORTIC ANEURYSM (DIAMETER WAS UNKNOWN) AND A MIGRATION OF A PROXIMAL SIDE OF THE TRUNK IPSILATERAL LEG COMPONENT WITH AN ENLARGEMENT OF THE PROXIMAL NECK WAS OBSERVED. ON (B)(6) 2022, COMPUTED TOMOGRAPHY REVEALED A MIGRATION OF THE PROXIMAL SIDE OF THE TRUNK IPSILATERAL LEG COMPONENT DISTALLY APPROXIMATELY 6 CM, AN ENLARGEM

  Patient problems: Clinical Endoleak

  MAUDE report 15466132 ↗
• InjuryDec 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FSA REPORTED: ON (B)(6) 2010, 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 IMAGES (DATE AND MODALITY IS UNKNOWN), REVEALED A POSSIBLE PROXIMAL TYPE I ENDOLEAK. THERE IS NO ANEURYSM SAC ENLARGEMENT. IT WAS REPORTED THERE WAS A REINTERVENTION ON (B)(6) 2021. THE PHYSICIAN IMPLANTED A GORE® EXCLUDER® AAA AORTIC EXTENDER ENDOPROSTHESIS PROXIMALLY. THE ENDOLEAK WAS RESOLVED. THE PATIENT TOLERATED THE REINTERVENTION.

  Patient problems: Aneurysm

  MAUDE report 12952188 ↗
• InjuryNov 7, 2021Backflow; Backflow

  ON (B)(6) 2008, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM AND WAS IMPLANTED WITH GORE® EXCLUDER® AAA ENDOPROSTHESES. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2021, THE PHYSICIAN REPORTED THIS PATIENT HAS A TYPE II ENDOLEAK (SOURCE UNKNOWN) WITH ANEURYSM ENLARGEMENT (AMOUNT UNKNOWN). PATIENT IS SCHEDULED FOR AN ANGIO ON (B)(6)2021. ON (B)(6) 2021, THE PATIENT UNDERWENT REINTERVENTION TO TREAT THE TYPE II ENDOLEAK WHICH APPEARED TO ORIGINATE FROM THE LEFT INTERNAL ILIAC ARTERY (LIIA). TWO DISTAL BRANCHES WERE COILED USING PENUMBRA RUBY COIL® S VIA THE LIIA. THE PATIENT TOLERATED THE PROCEDURE AND THE ENDOLEAK WAS RESOLVED. ANEURYSM ENLARGEMENT WAS CONFIRMED HOWEVER THE AMOUNT OF ENLARGEMENT REMAINED UNKNOWN.

  Patient problems: Aneurysm

  MAUDE report 12761638 ↗
• InjuryOct 30, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2008, THE PATIENT WAS IMPLANTED WITH GORE® EXCLUDER® AAA ENDOPROSTHESES TO TREAT AN ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT IMAGES REVEALED THE PATIENT HAD A DISTAL TYPE I ENDOLEAK (DATE AND MODALITY OF IMAGES IS UNKNOWN) IN THE LEFT COMMON ILIAC ARTERY. THERE IS ANEURYSM SAC ENLARGEMENT REPORTED (AMOUNT IS UNKNOWN). THE CAUSE FOR THE TYPE I ENDOLEAK IS UNKNOWN. THERE WAS A REINTERVENTION ON (B)(6) 2020. THE PHYSICIAN IMPLANTED A GORE® EXCLUDER® CONTRALATERAL LEG ENDOPROSTHESES BILATERALLY AND EXTENDED ALREADY IMPLANTED DEVICE IN THE RIGHT AND LEFT COMMON ILIAC ARTERIES. THE END RESULT WAS SUCCESSFUL WITH NO ENDOLEAK. THE PATIENT TOLERATED THE REINTERVENTION PROCEDURE. IT IS UNKNOWN WHICH IMPLANTED DEVICES HAD THE ENDOLEAK, THEREFORE, ALL IMPLANTED DEVICES WILL BE INCLUDED IN THIS EVENT.

  Patient problems: Aneurysm

  MAUDE report 10766871 ↗
• InjuryApr 6, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE LEFT RENAL ARTERY WAS SNORKELED, THE RIGHT RENAL ARTERY WAS PERISCOPED.

  Patient problems: Aneurysm

  MAUDE report 9929309 ↗
• InjuryDec 9, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2012, THIS PATIENT UNDERWENT ENDOVASCULAR REPAIR OF AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESIS. THE PATIENT WAS THEN LOST TO FOLLOW UP. THE PATIENT RETURNED FOR FOLLOW UP IN (B)(6) 2017 WITH AN ANEURYSM RUPTURE AND A TYPE 1A ENDOLEAK, AND A 32MM GORE® EXCLUDER® AAA ENDOPROSTHESIS AORTIC EXTENDER COMPONENT AND ENDURANT CUFF WERE PLACED. THE PATIENT IMPROVED AFTER THE TREATMENT, HOWEVER THE ANEURYSM CONTINUED TO INCREASE DUE TO A PERSISTENT TYPE 1A ENDOLEAK. THEREFORE IN (B)(6) 2018, ENDO-ANCHORS WERE PLACED. HOWEVER, THE ANEURYSM CONTINUED TO INCREASE. IN (B)(6) 2019, THE ENDOLEAK WAS TREATED WITH GLUE AND COIL EMBOLIZATION OF THE INFERIOR MESENTERIC ARTERY. IN (B)(6) 2019, FOLLOW UP REVEALED THE ANEURYSM HAD INCREASED BY ANOTHER 3MM.

  Patient problems: Aneurysm

  MAUDE report 9438449 ↗

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