GORE EXCLUDER AAA Endoprosthesis PXT281412Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00733132610297), received between Apr 13, 2021 and Oct 24, 2025 — classified as 8 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryOct 24, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED TO GORE THAT ON (B)(6) 2011, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM USING GORE EXCLUDER AAA ENDOPROSTHESES. A TOTAL OF FOUR COMPONENTS WERE DEPLOYED: ONE TRUNK IPSILATERAL LEG AND THREE CONTRALATERAL LEGS. ON (B)(6) 2025, A REINTERVENTION WAS PERFORMED AS BOTH COMMON ILIAC ARTERIES HAD BECOME ANEURYSMAL. A TOTAL OF SEVEN NEW COMPONENTS WERE PLACED: ONE CONTRALATERAL LEG, TWO ILIAC BRANCH COMPONENTS, TWO INTERNAL ILIAC COMPONENTS, AND TWO VBX. THE PATIENT TOLERATED THE PROCEDURE WELL.

  Patient problems: Aneurysm expansion; Clinical Endoleak

  MAUDE report 23376890 ↗
• InjuryOct 24, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED TO GORE THAT ON (B)(6) 2011, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM USING GORE EXCLUDER AAA ENDOPROSTHESES. A TOTAL OF FOUR COMPONENTS WERE DEPLOYED: ONE TRUNK IPSILATERAL LEG AND THREE CONTRALATERAL LEGS. THE PATIENT TOLERATED THE PROCEDURE WELL. ON AN UNKNOWN DATE IN 2018, DUE TO ENLARGEMENT OF THE ANEURYSM CAUSED BY A TYPE II ENDOLEAK, A REINTERVENTION INVOLVING ANEURYSM PLICATION WAS PERFORMED. THE ORIGIN OF THE TYPE II ENDOLEAK WAS REPORTED TO BE EITHER THE LUMBAR ARTERY OR THE INFERIOR MESENTERIC ARTERY. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Aneurysm expansion; Clinical Endoleak

  MAUDE report 23376862 ↗
• InjuryNov 22, 2024Migration; Device Endoleak; Migration; Device Endoleak

  ON (B)(6) 2010, THE PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE UTILIZING THE GORE® EXCLUDER® AAA ENDOPROSTHESIS (2 CONTRALATERAL LEGS, TRUNK IPSILATERAL, AORTIC EXTENDER). THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2024, THE PHYSICIAN REPORTED A CASE REFERRED TO HIM INVOLVING A PREVIOUSLY IMPLANTED EXCLUDER EVAR WITH A SUSPECTED TYPE 1 AND POSSIBLE MIGRATION. THE PHYSICIAN STATED THAT A FENESTRATED CUFF WILL BE PLACED AND THAT NO OTHER GORE SUPPORT WAS NECESSARY. NO ADDITIONAL INFORMATION IS KNOWN OR AVAILABLE. THE IMAGING EVALUATION DETERMINED THE FOLLOWING: THERE IS CONTRAST OUTSIDE THE DISTAL CONTRALATERAL LIMB IN THE LCI AND THERE IS LACK OF CIRCUMFERENTIAL DEVICE APPOSITION. THEREBY, CONFIRMING A DISTAL TYPE I ENDOLEAK.

  Patient problems: Clinical Endoleak

  MAUDE report 20765393 ↗
• InjuryFeb 6, 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 COMPONENTS 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 18655004 ↗
• InjuryNov 13, 2022Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING WAS INVESTIGATED AS PART OF A HISTORICAL GORE CASE (PSTS EVENT (B)(4)): THE FIELD SALES ASSOCIATE REPORTED THE FOLLOWING: ON (B)(6) 2008, THE PATIENT UNDERWENT TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM WITH A GORE® EXCLUDER® AAA ENDOPROSTHESIS TRUNK-IPSILATERAL LEG COMPONENT (PXT281412, SN:(B)(4)) AND TWO CONTRALATERAL LEG COMPONENTS (PXC181000, SN:(B)(4) AND PXC181200, SN: (B)(4)). ON (B)(6) 2013, FOLLOW-UP IMAGING IDENTIFIED AN UNSPECIFIED ENDOLEAK WITH ANEURYSM ENLARGEMENT OF AN UNKNOWN AMOUNT. ACCORDING TO THE PHYSICIAN, THE ENDOLEAK WAS IDENTIFIED AS A TYPE II ENDOLEAK WITH THE SOURCE MULTIPLE LUMBAR ARTERIES. ON (B)(6) 2013, THE PATIENT WAS IMPLANTED WITH GORE® EXCLUDER® AAA ENDOPROSTHESIS CONTRALATERAL LEG COMPONENT (PLC181000, SN:1(B)(4)). MEDICAL RECORDS INDICATE THAT IN 2013 A CT WAS PERFORMED AND THE MAXIMUM ANEURYSM SAC MEASURED 7.4 X 6.6CMS. THIS REPORT/CASE/INVESTIGATION WAS OPENED TO FOR THE FOLLOWING: ON (B)(6) 2016, THE PATIENT WAS IMPLANTED WITH A GORE® EXCLUDER® AAA ENDOPROSTHESIS AORTIC EXTENDER. MEDICAL RECORDS INDICATE THAT ON (B)(6) 2016 A CT WAS PERFORMED AND THE MAXIMUM ANEURYSM SAC MEASURED 8.8 X 7.2CMS.

  Patient problems: Clinical Endoleak

  MAUDE report 15786110 ↗
• InjuryNov 13, 2022Adverse Event Without Identified Device or Use Problem; Therapeutic or Diagnostic Output Failure; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING WAS CAPTURED IN A HISTORICAL RECORD: ON (B)(6) 2008, THE PATIENT UNDERWENT TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM WITH A GORE® EXCLUDER® AAA ENDOPROSTHESIS TRUNK-IPSILATERAL LEG COMPONENT AND TWO CONTRALATERAL LEG COMPONENTS ON (B)(6) 2013, FOLLOW-UP IMAGING IDENTIFIED AN UNSPECIFIED ENDOLEAK WITH ANEURYSM ENLARGEMENT OF AN UNKNOWN AMOUNT. ACCORDING TO THE PHYSICIAN, THE ENDOLEAK WAS IDENTIFIED AS A TYPE II ENDOLEAK WITH THE SOURCE MULTIPLE LUMBAR ARTERIES. ON (B)(6) 2013, THE PATIENT WAS IMPLANTED WITH GORE® EXCLUDER® AAA ENDOPROSTHESIS CONTRALATERAL LEG COMPONENT (PLC181000, SN:(B)(4)). MEDICAL RECORDS INDICATE THAT IN 2013 A CT WAS PERFORMED AND THE MAXIMUM ANEURYSM SAC MEASURED 7.4 X 6.6CMS. ON (B)(6) 2016, THE PATIENT WAS IMPLANTED WITH A GORE® EXCLUDER® AAA ENDOPROSTHESIS AORTIC EXTENDER (MPDCASE-00011054) MEDICAL RECORDS INDICATE THAT ON (B)(6) 2016 A CT WAS PERFORMED AND THE MAXIMUM ANEURYSM SAC MEASURED 8.8 X 7.2CMS. ON (B)(6) 2017 A CT WAS PERFORMED AND THE MAXIMUM ANEURYSM SAC MEASURED 8.9 X 8.1CMS. ON (B)(6) 2019, A CT WAS PERFORMED AND THE MAXIMUM ANEURYSM SAC MEASURED 9.8 X 8.6CMS. THE FOLLOWING IS NEW INFORMATION: AS REPORTED BY THE FSA, ON (B)(6) 20

  Patient problems: Clinical Endoleak; Ruptured Aneurysm

  MAUDE report 15786068 ↗
• InjuryApr 23, 2021Migration; Migration

  FSA BRION CROW RECEIVED A TEXT FROM A PHYSICIAN THAT A GORE® EXCLUDER® AAA ENDOPROSTHESIS IMPLANTED IN 2008 HAD MIGRATED. IT WAS A PROXIMAL MIGRATION WITH A TYPE 1 ENDOLEAK. THE PHYSICIAN HAS NOT CONTACTED THE FSA ABOUT A REINTERVENTION.

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

  MAUDE report 11717842 ↗
• InjuryApr 13, 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 ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESIS. ON (B)(6) 2020, ANEURYSM ENLARGEMENT WAS IDENTIFIED DUE TO A TYPE II ENDOLEAK ORIGINATING FROM THE INFERIOR MESENTERIC ARTERY. ON THE SAME DAY, TREATMENT WAS PERFORMED WHEREBY COIL EMBOLIZATION OF THE INFERIOR MESENTERIC ARTERY WAS PERFORMED. THE ENDOLEAK WAS RESOLVED.

  Patient problems: Aneurysm

  MAUDE report 11656495 ↗

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