GORE EXCLUDER AAA Endoprosthesis PXC141000Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00733132609949), received between Dec 26, 2018 and Mar 27, 2025 — classified as 12 injuries.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (3 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryMar 27, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2009, THE PATIENT UNDERWENT AN UNKNOWN ENDOVASCULAR PROCEDURE UTILIZING GORE® EXCLUDER® AAA ENDOPROSTHESIS. ON AN UNKNOWN DATE, THE PATIENT WAS BROUGHT IN A FOR REINTERVENTION ON THE RIGHT SIDE WHERE THE CONTRALATERAL LEG (PXC141000) WAS IMPLANTED FOR A TYPE 1B ENDOLEAK WHICH WAS COIL EMBOLIZED THEN EXTENDED DISTALLY WITH A FLARED LIMB. ON (B)(6) 2025, THE PATIENT UNDERWENT AN ENDOVASCULAR REINTERVENTION PROCEDURE TO TREAT AN COMMON AND INTERNAL ILIAC ANEURYSM UTILIZING A GORE® DRYSEAL FLEX INTRODUCER SHEATH AS AN ACCESSORY. REPORTEDLY, THE MAIN BODY TRUNK IPSILATERAL GRAFT HAD MIGRATED DOWN BY 5CM FROM THE RENALS LEADING TO A TYPE 1B ENDOLEAK ON THE LEFT CONTRALATERAL (PXC201400) WITH ANEURYSM GROWTH IN THE COMMON ILIAC ARTERY (SIZE UNKNOWN). REINTERVENTION WAS DONE TO TREAT THE ENDOLEAK WITH IPSILATERAL IBE AND TO PRESERVE THE INTERNAL ILIAC ARTERY. DURING THE GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS (IBE) PROCEDURE, A CONTRALATERAL SIDE UP AND OVER THE FLOW DIVIDER OF THE IBE DEVICE WAS DONE BY BASICALLY DELIVERING A GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX) INTO THE DISTAL PART OF THE INTERNAL ILIAC ARTERY. THE D

  Patient problems: Aneurysm expansion; Clinical Endoleak

  MAUDE report 21714024 ↗
• InjuryAug 27, 2024Patient-Device Incompatibility; Device-Device Incompatibility; Patient-Device Incompatibility; Device-Device Incompatibility

  ON (B)(6) 2013, THIS PATIENT UNDERWENT AN ENDOVASCULAR TREATMENT FOR ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESIS. ON AN UNKNOWN DATE, ANEURYSM ENLARGEMENT WAS NOTED. APPROXIMATELY TWO YEARS BEFORE THE TIME OF REPORTING, THE PATIENT RECEIVED EMBOLIZATION OF THE INFERIOR MESENTERIC ARTERY FOR A TYPE II ENDOLEAK. (THIS EVENT HAS BEEN SEPARATELY REPORTED IN REPORT# 2953161-2024-01215). ON (B)(6) 2024, A FOLLOW-UP CT SCAN SHOWED FURTHER ANEURYSM ENLARGEMENT AND A SUSPECTED TYPE IB ENDOLEAK ON THE RIGHT SIDE. AN ADDITIONAL TREATMENT WAS INDICATED. ON (B)(6) 2024, PRELIMINARY EMBOLIZATION OF THE RIGHT INTERNAL ILIAC ARTERY WAS PERFORMED. AN ANGIOGRAPHY DURING PROCEDURE SHOWED ANOTHER TYPE OF ENDOLEAK (SUSPECTED TYPE IA, TYPE IIIA OR TYPE IIIB). ON (B)(6) 2024, A REINTERVENTION WAS PERFORMED. AN AORTIC EXTENDER WAS PLACED AT THE PROXIMAL SIDE AND A CONTRALATERAL LEG WAS PLACED AT THE RIGHT DISTAL SIDE AND CONNECTION SITE OF THE PREVIOUS DEVICES. ALSO, ANOTHER CONTRALATERAL LEG WAS PLACED ON THE LEFT SIDE TO RELINE THE PREVIOUS IPSILATERAL LEG JUST IN CASE. THERE WAS NO MORE OBVIOUS ENDOLEAKS. THE PATIENT TOLERATED THE PROCEDURE. THE REPORTING PHYSICIAN COMMENTED AS F

  Patient problems: Aneurysm expansion; Clinical Endoleak

  MAUDE report 20073338 ↗
• InjuryJul 12, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  ON (B)(6) 2011, THIS PATIENT UNDERWENT AN ENDOVASCULAR TREATMENT FOR ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESIS. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2024, A REINTERVENTION WAS PERFORMED DUE TO A TYPE IB ENDOLEAK OF THE LEFT SIDE (PXC141000) AND ANEURYSM ENLARGEMENT WHICH WERE FOUND DURING A FOLLOW-UP EXAMINATION. GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS (IBE) WAS IMPLANTED IN THE LEFT SIDE AND THE ENDOLEAK DISAPPEARED. ALSO, AN ADDITIONAL CONTRALATERAL LEG WAS IMPLANTED IN THE RIGHT SIDE TOO TO PREVENT TYPE IB ENDOLEAK. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Aneurysm expansion; Clinical Endoleak

  MAUDE report 19727822 ↗
• 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. 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: Clinical Endoleak

  MAUDE report 18744804 ↗
• InjurySep 25, 2023Adverse Event Without Identified Device or Use Problem; Migration; Adverse Event Without Identified Device or Use Problem; Migration

  IT WAS REPORTED THAT ON (B)(6) 2012, A PATIENT PRESENTING WITH AN ABDOMINAL AORTIC ANEURYSM WAS TREATED WITH A GORE EXCLUDER AAA ENDOPROSTHESIS WITH C3 DELIVERY SYSTEM. ON (B)(6) 2020, THE PATIENT PRESENTING WITH EXPANSION OF THE LEFT SIDED ILIAC ANEURYSM REPORTEDLY CAUSED BY MIGRATION OF THE TRUNK IPSILATERAL LEG. ON (B)(6) 2021, THE PATIENT WAS TREATED WITH COIL EMBOLIZATION OF LEFT ILIAC INTERNAL BRANCHES AND IMPLANTATION OF AN ADDITIONAL DEVICE IN THE LEFT ILIAC ARTERY.

  Patient problems: Aneurysm; Aneurysm expansion

  MAUDE report 17807260 ↗
• InjuryJun 11, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2013, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN INFLAMMATORY ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESES. ON AN UNKNOWN DATE, A DISTAL TYPE I ENDOLEAK IN THE LEFT LEG, PROXIMAL MIGRATION (DISTANCE UNKNOWN) OF THE DISTAL END OF THE CONTRALATERAL LEG ENDOPROSTHESIS, AND ANEURYSM ENLARGEMENT (AMOUNT UNKNOWN) WERE OBSERVED. ON (B)(6) 2021, A REINTERVENTION WAS PERFORMED WHEREBY AN ADDITIONAL STENT GRAFT (PLC121000J) WAS PLACED IN THE LEFT EXTERNAL ILIAC ARTERY. THE DISTAL TYPE I ENDOLEAK WAS RESOLVED. THE PHYSICIAN STATED THAT ANEURYSM ENLARGEMENT MAY HAVE CAUSED THE PROXIMAL MIGRATION OF THE DISTAL END OF THE CONTRALATERAL LEG ENDOPROSTHESIS.

  Patient problems: Aneurysm

  MAUDE report 11987964 ↗
• InjuryMar 30, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2014, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESIS. ON (B)(6) 2017 AN ENDOLEAK OF UNKNOWN ORIGIN WAS DISCOVERED ON FOLLOW UP. ON THE SAME DAY, A REINTERVENTION OCCURRED WHEREBY EMBOLIZATION OF A BRANCH VESSEL WAS PERFORMED. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Aneurysm

  MAUDE report 11590222 ↗
• InjuryOct 14, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2017, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM WITH GORE® EXCLUDER® AAA ENDOPROSTHESES, AND TREATMENT OF A RIGHT ILIAC ANEURYSM TREATED WITH GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESES. IT WAS REPORTED THAT AN ENDOLEAK (UNKNOWN TYPE) IN THE RIGHT EXTERNAL ILIAC ARTERY WAS REVEALED (MODALITY AND DATE IS UNKNOWN). THE ANEURYSM IN THE RIGHT EXTERNAL ILIAC ARTERY HAD ENLARGED (AMOUNT OF ENLARGEMENT IS UNKNOWN). THE PHYSICIAN REINTERVENED ON (B)(6) 2020, AND RELINED AND EXTENDED THE IMPLANTED CONTRALATERAL LEG ENDOPROSTHESIS (PXC141000/14826821) WITH A CONTRALATERAL LEG ENDOPROSTHESIS PROXIMALLY AND DISTALLY. THE PHYSICIAN ALSO COIL EMBOLIZED THE RIGHT HYPOGASTRIC ARTERY. THE ENDOLEAK WAS RESOLVED. THE PATIENT TOLERATED THE REINTERVENTION PROCEDURE.

  Patient problems: Aneurysm

  MAUDE report 10681079 ↗
• InjuryOct 16, 2019Patient Device Interaction Problem; Patient Device Interaction Problem

  ON (B)(6) 2016, THIS PATIENT UNDERWENT ENDOVASCULAR REPAIR OF A PREVIOUS ENDOVASCULAR PROCEDURE WHEREBY THREE GORE® EXCLUDER® AAA ENDOPROSTHESES CONTRALATERAL LEG COMPONENTS WERE IMPLANTED TO TREAT A DISTAL TYPE B ENDOLEAK FROM A TALENT STENT GRAFT. ON (B)(6) 2019, A TYPE 2 ENDOLEAK WAS IDENTIFIED. ON (B)(6) 2019, A REINTERVENTION OCCURRED WHEREBY COIL EMBOLIZATION OF THE LEFT COMMON AND HYPOGASTRIC ARTERY WAS PERFORMED.

  Patient problems: Aneurysm

  MAUDE report 9199269 ↗
• InjuryOct 8, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2015, THE PATIENT WAS IMPLANTED WITH GORE® EXCLUDER® AAA ENDOPROSTHESES TO TREAT AN ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT FOLLOW UP COMPUTED TOMOGRAPHY (CT) DATED (B)(6) 2019, REVEALED THE PATIENT HAD A POSSIBLE PROXIMAL TYPE I ENDOLEAK OR A TYPE III ENDOLEAK WITH COMPONENT DISCONNECTION. IT IS UNKNOWN IF THERE IS ANEURYSM SAC ENLARGEMENT. THE EVENT IS ONGOING.

  Patient problems: Aneurysm

  MAUDE report 9165810 ↗
• InjuryFeb 12, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2016, A PATIENT WAS UNDERGOING TREATMENT OF AN ABDOMINAL AND LEFT COMMON ILIAC ARTERY ANEURYSMS MEASURING 79.2MM ¿ABDOMINAL, 25.7MM- LEFT ILIAC WITH GORE® EXCLUDER® AAA ENDOPROSTHESES. REPORTEDLY, DURING THE INITIAL PROCEDURE THE LEFT INTERNAL ILIAC ARTERY WAS EMBOLIZED. THE PATIENT TOLERATED THE PROCEDURE. THE FOLLOW UP IMAGES FROM (B)(6) 2018 REVEALED THAT THE LEFT COMMON ILIAC ARTERY ANEURYSM ENLARGED IN DIAMETER FROM 26MM TO 36MM. NO FURTHER ADVERSE EVENTS HAVE BEEN REPORTED. THE EVENT IS ONGOING.

  Patient problems: Aneurysm

  MAUDE report 8333455 ↗
• InjuryDec 26, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  ON (B)(6) 2015, THE PATIENT WAS IMPLANTED WITH TWO GORE® EXCLUDER® AAA ENDOPROSTHESES. ON (B)(6) 2018, A COMPUTED TOMOGRAPHY (CT) SCAN REPORTEDLY REVEALED A SUSPECTED TYPE II ENDOLEAK CONTRIBUTING TO ANEURYSM GROWTH (AMOUNT NOT REPORTED). ON (B)(6) 2018, THE PATIENT UNDERWENT A SECONDARY INTERVENTION PROCEDURE. AN INTRA-OPERATIVE ANGIOGRAPH REVEALED WHAT WAS THOUGHT TO BE A TYPE III ENDOLEAK WITH A HOLE OR DISRUPTION IN THE GRAFT MATERIAL. THE PHYSICIAN ELECTED TO RE-LINE BOTH DISTAL LIMBS WITH ADDITIONAL 14MM EXCLUDER® CONTRALATERAL LEG COMPONENTS. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8196010 ↗

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)