GORE EXCLUDER AAA Endoprosthesis PXC181400Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00733132610020), received between Dec 8, 2020 and Dec 3, 2025 — classified as 7 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryDec 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2009, THE PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE TO TREAT AN ANEURYSM, UTILIZING GORE® EXCLUDER® AAA ENDOPROSTHESIS (CONTRALATERAL LEG COMPONENT). ON (B)(6) 2025, PATIENT PRESENTED WITH DISEASE PROGRESSION IN THE RIGHT COMMON ILIAC ARTERY, DISTAL TO THE ORIGINAL PLACEMENT OF THE CONTRALATERAL LEG COMPONENT. ON (B)(6) 2025, THE PATIENT UNDERWENT REINTERVENTION SURGERY, IN WHICH COIL EMBOLIZATION OF THE RIGHT INTERNAL ILIAC ARTERY WAS PERFORMED AND PLACEMENT OF PLC141400 AND PLC1212100 FROM THE FLOW DIVIDER OF EXISTING GRAFT (PXC181400 L/S#: (B)(6), TO THE RIGHT EXTERNAL ILIAC ARTERY, TO TREAT THE DISEASED SEGMENT DISTAL TO ORIGINAL IMPLANTED DEVICE. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Aneurysm expansion

  MAUDE report 23707725 ↗
• InjuryMay 26, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2013, THE PATIENT UNDERWENT AN ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER®AAA ENDOPROSTHESES. ON AN UNKNOWN DATE IN 2025, FOLLOW-UP EXAMINATION CONFIRMED A DISTAL TYPE I ENDOLEAK FROM THE LEFT DISTAL SIDE. ON (B)(6) 2025, A REINTERVENTION WAS PERFORMED, AS THE TREATMENT FOR THE DISTAL TYPE I ENDOLEAK, TWO STENT GRAFTS WERE IMPLANTED IN THE LEFT DISTAL SIDE. THE ENDOLEAK WAS RESOLVED.

  Patient problems: Clinical Endoleak

  MAUDE report 22085240 ↗
• InjuryApr 1, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE THROUGH THE GLOBAL REGISTRY FOR ENDOVASCULAR AORTIC TREATMENT (GREAT 10-11): ON (B)(6) 2012, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM WITH GORE® EXCLUDER® AAA ENDOPROSTHESES. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2016, THE ANEURYSM DIAMETER WAS REPORTED TO MEASURE 70MM. ON (B)(6) 2018, THE MAXIMUM DIAMETER OF THE AORTIC ANEURYSM/LESION WAS 98MM. FROM (B)(6) 2021 TO (B)(6) 2022 THE ANEURYSM EXPANDED FROM 92MM TO 100MM. ADDITIONALLY, THE LATEST IMAGING FROM (B)(6) 2022 SHOWED A STABLE AORTIC DIAMETER, BUT PRESENCE OF A DISTAL TYPE I ENDOLEAK FROM LEFT COMMON ILIAC ARTERY. IT IS UNKNOWN WHAT DEVICE WAS IMPLANTED ON THE LEFT SIDE AS THE DEVICES WERE NOT IMPLANTED AT NORTHWESTERN MEMORIAL HOSPITAL. IT WAS REPORTED THAT ON (B)(6) 2023, THE PATIENT EXPIRED DUE TO THE ABDOMINAL AORTIC ANEURYSM WITHOUT RUPTURE, SYSTOLIC HEART FAILURE, ATRIAL FIBRILLATION. IT WAS REPORTED BY THE SITE THAT THE PHYSICIAN COULD NOT CONFIRM THAT THE ABDOMINAL AORTIC ANEURYSM CAUSED THE DEATH. ACCORDING TO THE PHYSICIAN, THERE IS NO CORROBORATING INFORMATION AVAILABLE, AND THE PATIENT HAD MANY ADDITIONAL MEDICAL PROBLEMS

  Patient problems: Aneurysm expansion; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Clinical Endoleak

  MAUDE report 19016527 ↗
• InjuryFeb 8, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2008, THIS PATIENT UNDERWENT AN ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER®AAA ENDOPROSTHESES. ON (B)(6) 2020, A REINTERVENTION WAS PERFORMED TO TREAT A DISTAL TYPE I ENDOLEAK FROM THE RIGHT COMMON ILIAC ARTERY. GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS (IBE) WAS IMPLANTED INTO THE RIGHT SIDE OF THE PATIENT AS A TREATMENT. AN AORTIC EXTENDER COMPONENT WAS ALSO IMPLANTED PROXIMALLY FOR A SUSPECTED PROXIMAL TYPE I ENDOLEAK. ON AN UNKNOWN DATE, EMBOLIZATION WITH NBCA WAS PERFORMED (DETAILS UNKNOWN). ON (B)(6) 2024, A REINTERVENTION WAS PERFORMED TO TREAT A DISTAL TYPE I ENDOLEAK FROM THE LEFT COMMON ILIAC ARTERY USING GORE® EXCLUDER®AAA ENDOPROSTHESES. A CONTRALATERAL LEG COMPONENT WAS IMPLANTED INTO THE LEFT SIDE OF THE PATIENT AS A TREATMENT. TWO AORTIC EXTENDER COMPONENT WERE ALSO IMPLANTED PROXIMALLY FOR A SUSPECTED PROXIMAL TYPE I ENDOLEAK. ANEURYSM ENLARGEMENT WAS NOT REPORTED. ADDITIONAL DETAILS OF THE 2008 AND 2020 PROCEDURES WERE NOT ABLE TO BE OBTAINED.

  Patient problems: Clinical Endoleak

  MAUDE report 18669130 ↗
• InjuryOct 22, 2021Patient Device Interaction Problem; Patient Device Interaction Problem

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2011, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESIS. ON AN UNKNOWN DATE IN (B)(6) 2021, A DISTAL TYPE I ENDOLEAK AT THE RIGHT SIDE WAS OBSERVED ON THE FOLLOW UP CT IMAGING. ON (B)(6) 2021, REINTERVENTION TOOK PLACE, THE RIGHT INTERNAL ILIAC ARTERY WAS EMBOLIZED AS PLANNED AND AN ADDITIONAL STENT GRAFT WAS PLACED TO EXTEND THE TREATMENT AREA UPTO THE RIGHT EXTERNAL ILIAC ARTERY. THE PATIENT TOLERATED THE PROCEDURE.

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

  MAUDE report 12682229 ↗
• InjurySep 9, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2011, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESIS. REPORTEDLY, THE ANEURYSM HAS ENLARGED BY ABOUT 8 MM PER EVERY YEAR SINCE 2015. ON AN UNKNOWN DATE IN (B)(6) 2021, IT WAS CONFIRMED THAT THE DIAMETER OF THE ANEURYSM WAS 107 MM, AND MIGRATION AND A DISTAL TYPE I ENDOLEAK ON LEFT SIDE WERE DISCOVERED. ON (B)(6) 2021, A REINTERVENTION TO PLACE AN ADDITIONAL STENT GRAFT WAS PERFORMED. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Aneurysm

  MAUDE report 12447733 ↗
• InjuryDec 8, 2020Patient-Device Incompatibility; Patient-Device Incompatibility

  ON (B)(6) 2012 THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM USING GORE(R) EXCLUDER(R) AAA ENDOPROSTHESES. THE PATIENT TOLERATED THE PROCEDURE. ON AN UNKNOWN DATE, IT WAS REPORTED THAT THE ANEURYSM WAS ENLARGED (AMOUNT UNKNOWN). BASED ON IMAGING (MODALITY UNKNOWN) IT WAS CONSIDERED THAT THE DISTAL END OF THE CONTRALATERAL LEG COMPONENT, IMPLANTED AS A DISTAL EXTENSION OF THE IPSILATERAL LEG ON THE PATIENT'S RIGHT SIDE, LOST APPOSITION TO THE RIGHT COMMON ILIAC ARTERY. ON (B)(6) 2020, THE PATIENT UNDERWENT A THORACIC ENDOVASCULAR PROCEDURE TO TREAT A DISTAL ARCH ANEURYSM. AT THAT TIME, RE-INTERVENTION FOR THE CONTRALATERAL LEG COMPONENT WAS ALSO PERFORMED. THE PATIENT'S RIGHT INTERNAL ILIAC ARTERY WAS EMBOLIZED, AND AN ADDITIONAL CONTRALATERAL LEG COMPONENT WAS IMPLANTED DISTAL TO THE PREVIOUSLY IMPLANTED DEVICE. THE PHYSICIAN REPORTEDLY NOTED THAT, PRIOR TO THE RE-INTERVENTION, THERE WAS NO APPARENT ENDOLEAK, BUT IT WAS CONSIDERED THAT THE RIGHT LEG WAS NOT APPOSED TO THE VESSEL WALL. IT WAS ALSO NOTED THAT THE SEALING LENGTH OF BOTH THE PROXIMAL NECK AND THE LEFT LEG OF THE ENDOPROSTHESIS HAD BECOME SHORTER DUE TO ANEURYSM ENLARGEMENT. IT WAS NOTED T

  Patient problems: Aneurysm

  MAUDE report 10969022 ↗

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