GORE EXCLUDER AAA Endoprosthesis PXC181200Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00733132610013), received between Aug 13, 2018 and Nov 28, 2023 — classified as 3 injuries.

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

• InjuryNov 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2010, THE PATIENT UNDERWENT AN ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESES. ON AN UNKNOWN DATE, A FOLLOW-UP EXAM REVEALED AN ANEURYSM ENLARGEMENT. IT WAS NOT CONFIRMED AN OBVIOUS ENDOLEAK BY AN IMAGE, BUT A DISTAL TYPE I ENDOLEAK WAS SUSPECTED BECAUSE THE RIGHT COMMON ILIAC ARTERY WAS DILATED (THE DIAMETER BECAME ABOUT 20 MM). ON (B)(6) 2023, A REINTERVENTION WAS PERFORMED. THE RIGHT INTERNAL ILIAC ARTERY WAS EMBOLIZED AND A CONTRALATERAL LEG ENDOPROSTHESIS WAS IMPLANTED TO EXTEND THE RIGHT LEG TO THE RIGHT EXTERNAL ILIAC ARTERY. THERE WAS NO ENDOLEAK AND THE PROCEDURE WAS CONCLUDED.

  Patient problems: Aneurysm expansion; Clinical Endoleak; Vasodilatation

  MAUDE report 18223154 ↗
• InjuryNov 20, 2018Patient-Device Incompatibility; Patient-Device Incompatibility

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2012, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM WITH A DIAMETER MEASURING 52 MM AND WAS TREATED WITH GORE® EXCLUDER® AAA ENDOPROSTHESES. ON (B)(6) 2013, COMPUTED TOMOGRAPHY ANGIOGRAPHY IMAGING (CTA) IDENTIFIED THE ANEURYSM MEASURING 46 MM. ON (B)(6) 2014, AND ON (B)(6) 2016, CT IMAGING IDENTIFIED THE ANEURYSM MEASURING 48 MM AND 50 MM, RESPECTIVELY. DURING FOLLOW-UP CTA IMAGING ON (B)(6) 2018, IT WAS FOUND THAT THE GORE® EXCLUDER® CONTRALATERAL LEG COMPONENT PXC181200 / (B)(4) IMPLANTED ON THE RIGHT PATIENT SIDE HAD SHORT SHORTENED DUE TO DISEASE PROGRESSION. A TYPE 1B ENDOLEAK WAS HOWEVER NOT REPORTED. ADDITIONALLY, AN ANEURYSM DIAMETER OF 51 MM WAS CONFIRMED. ON (B)(6) 2018, AN ADDITIONAL STENT WAS IMPLANTED INTO THE RIGHT COMMON ILIAC ARTERY TO EXTEND THE PXC181200 COMPONENT TO AGAIN PROVIDE ADEQUATE SEAL.

  Patient problems: No Code Available

  MAUDE report 8088699 ↗
• InjuryAug 13, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  ON (B)(6) 2014, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM MEASURING 65MM IN DIAMETER, AND WAS IMPLANTED WITH GORE® EXCLUDER® AAA ENDOPROSTHESES. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2014, (B)(6) 2015 AND (B)(6) 2016 THE FOLLOW UP COMPUTED TOMOGRAPHY SCANS DETERMINED THAT THE MAXIMUM DIAMETER OF AORTIC ANEURYSM/LESION WAS 62MM. IT WAS REPORTED THAT ON (B)(6) 2016, A DISTAL TYPE I ENDOLEAK FROM THE RIGHT ILIAC ARTERY WAS IDENTIFIED AND THE PATIENT UNDERWENT ENDOVASCULAR PROCEDURE USING MEDTRONIC DEVICES. THE ENDOLEAK WAS RESOLVED. THE PATIENT TOLERATED THE PROCEDURE. ACCORDING TO THE PHYSICIAN, REMODELING OF THE RIGHT COMMON ILIAC ARTERY AND THE ANEURYSMAL SAC CAUSED THE ENDOLEAK.

  Patient problems: Aneurysm

  MAUDE report 7779419 ↗

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)