GORE EXCLUDER AAA Endoprosthesis PXC161400Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00733132609994), received between Nov 12, 2020 and Nov 13, 2024 — classified as 5 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryNov 13, 2024Adverse 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) 2012, A PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESES. A CONTRALATERAL LEG WAS IMPLANTED IN THE RIGHT LEG. ANOTHER CONTRALATERAL LEG WAS IMPLANTED IN THE LEFT LEG. ON UNKNOWN DATE, AT A FOLLOW UP, AN ENLARGEMENT OF THE ANEURYSM WAS OBSERVED. ON (B)(6) 2024, A REINTERVENTION WAS PERFORMED. THE CAUSE OF THE ANEURYSM ENLARGEMENT WAS UNKNOWN; HOWEVER, A LUMBAR ARTERY WAS EMBOLIZED FOR A SUSPECTED TYPE II ENDOLEAK, ADDITIONAL STENT GRAFT WAS IMPLANTED TO EXTEND DISTALLY IN THE RIGHT LEG AFTER COIL EMBOLIZATION OF THE RIGHT INTERNAL ILIAC ARTERY, AND ADDITIONAL STENT GRAFTS WERE IMPLANTED INTO THE LEFT LEG. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Aneurysm expansion

  MAUDE report 20679558 ↗
• InjuryJul 25, 2024Patient-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 USING GORE® EXCLUDER® AAA ENDOPROSTHESES. ON AN UNKNOWN DATE, A FOLLOW-UP CT DETERMINED A TYPE I ENDOLEAK IN THE DISTAL END OF THE CONTRALATERAL LEG THAT HAD BEEN IMPLANTED INTO THE LEFT COMMON ILIAC ARTERY. ON (B)(6) 2024, A REINTERVENTION WAS PERFORMED. THE LEFT INTERNAL ILIAC ARTERY WAS COIL EMBOLIZED, AND TWO ADDITIONAL STENT GRAFTS WERE IMPLANTED EXTENDING TO THE LEFT EXTERNAL ILIAC ARTERY. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Clinical Endoleak

  MAUDE report 19828430 ↗
• InjuryJun 2, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2011, A PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESES. PXC161400, SERIAL NUMBER (B)(4) WAS IMPLANTED IN THE RIGHT LEG. PXC161400, SERIAL NUMBER (B)(4), WAS IMPLANTED IN THE LEFT LEG. AFTER ALL DEVICES WERE IMPLANTED, AN ANGIOGRAPHY REVEALED TWO TYPE II ENDOLEAKS. THE PHYSICIAN DECIDED TO MONITOR THEM. ON AN UNKNOWN DATE, AT A FOLLOW UP, TREND OF DILATIONS OF BILATERAL COMMON ILIAC ARTERIES WAS OBSERVED. A POSSIBILITY OF DISTAL TYPE I ENDOLEAKS WAS A CONCERN. ON (B)(6) 2022, A REINTERVENTION WAS PERFORMED PREVENTIVELY. THE BILATERAL INTERNAL ILIAC ARTERIES WERE EMBOLIZED USING AVPII. TWO STENT GRAFTS WERE IMPLANTED IN THE RIGHT LEG TO EXTEND TO THE RIGHT EXTERNAL ILIAC ARTERY. TWO STENT GRAFTS WERE IMPLANTED IN THE LEFT LEG TO EXTEND TO THE LEFT EXTERNAL ILIAC ARTERY. A DISTAL SUBTRACTION ANGIOGRAPHY REVELATED NO DISTAL TYPE I ENDOLEAK AND NO TYPE II ENDOLEAK. THE PATIENT TOLERATED THE PROCEDURE. (B)(4). REPORTEDLY, THE TREND OF DILATIONS OF BILATERAL COMMON ILIAC ARTERIES MAY BE AN EFFECT OF A PROGRESSION OF THE PATIENT'S DISEASE. NO DEVICE RELATED DILATION WAS REPORTED.

  Patient problems: Aneurysm

  MAUDE report 14575125 ↗
• InjuryJun 2, 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) 2011, A PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESES. PXC161400, (B)(4) WAS IMPLANTED IN THE RIGHT LEG. PXC161400, (B)(4), WAS IMPLANTED IN THE LEFT LEG. AFTER ALL DEVICES WERE IMPLANTED, AN ANGIOGRAPHY REVEALED TWO TYPE II ENDOLEAKS. THE PHYSICIAN DECIDED TO MONITOR THEM. MPDCASE- (B)(4). ON AN UNKNOWN DATE, AT A FOLLOW UP, TREND OF DILATIONS OF BILATERAL COMMON ILIAC ARTERIES WAS OBSERVED. A POSSIBILITY OF DISTAL TYPE I ENDOLEAKS WAS A CONCERN. ON (B)(6) 2022, A REINTERVENTION WAS PERFORMED PREVENTIVELY. THE BILATERAL INTERNAL ILIAC ARTERIES WERE EMBOLIZED USING AVPII. TWO STENT GRAFTS WERE IMPLANTED IN THE RIGHT LEG TO EXTEND TO THE RIGHT EXTERNAL ILIAC ARTERY. TWO STENT GRAFTS WERE IMPLANTED IN THE LEFT LEG TO EXTEND TO THE LEFT EXTERNAL ILIAC ARTERY. A DISTAL SUBTRACTION ANGIOGRAPHY REVELATED NO DISTAL TYPE I ENDOLEAK AND NO TYPE II ENDOLEAK. THE PATIENT TOLERATED THE PROCEDURE. (B)(4) REPORTEDLY, THE TREND OF DILATIONS OF BILATERAL COMMON ILIAC ARTERIES MAY BE AN EFFECT OF A PROGRESSION OF THE PATIENT'S DISEASE. NO DEVICE RELATED DILATION WAS REPORTED

  Patient problems: Aneurysm

  MAUDE report 14575116 ↗
• InjuryNov 12, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON (B)(6) 2014, A PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESES. A PXC161400 WAS IMPLANTED IN THE LEFT COMMON ILIAC ARTERY. ON AN UNKNOWN DATE IN (B)(6) 2020, POSTOPERATIVE FOLLOW-UP EXAMINATION CONFIRMED THAT THE DIAMETER OF THE LEFT COMMON ILIAC ARTERY HAD ENLARGED, RESULTING IN DEVICE MIGRATION PROXIMALLY. NO ENDOLEAK WAS DETECTED. ON (B)(6) 2020, A REINTERVENTION WAS PERFORMED. THE LEFT INTERNAL ILIAC ARTERY WAS EMBOLIZED, AND AN ADDITIONAL STENT GRAFT WAS IMPLANTED INTO THE LEFT EXTERNAL ILIAC ARTERY. IT WAS REPORTED THAT THE EVENT WAS CAUSED BY THE POOR CONDITION OF THE PATIENT'S COMMON ILIAC ARTERY.

  Patient problems: Aneurysm

  MAUDE report 10830648 ↗

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)