GORE EXCLUDER AAA Endoprosthesis PXT261412Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00733132610211), received between Sep 10, 2018 and Apr 29, 2025 — classified as 13 injuries.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (6 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjuryApr 29, 2025Migration; Migration

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2012, THIS PATIENT UNDERWENT AN ENDOVASCULAR TREATMENT FOR ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESIS. DURING A FOLLOW-UP EXAMINATION, DISTAL MIGRATION (APPROX. 1.5 CM) OF THE TRUNK-IPSILATERAL LEG WAS NOTED. THEREFORE, A REINTERVENTION WAS INDICATED, THOUGH NO ENDOLEAK WAS SHOWN. ON (B)(6) 2025, AN ADDITIONAL PROCEDURE WAS PERFORMED. TWO AORTIC EXTENDERS WERE IMPLANTED PROXIMAL TO THE TRUNK-IPSILATERAL LEG. DURING THE PROCEDURE, IT WAS FOUND THAT THROMBUS FORMATION INSIDE THE CONTRALATERAL LEG AND ILIAC EXTENDER ON THE RIGHT SIDE. THROMBUS ASPIRATION WAS PERFORMED THROUGH THE INTRODUCER SHEATH AND AN ADDITIONAL CONTRALATERAL LEG WAS PLACED TO FIX THE REMAINING THROMBI. REPORTEDLY, THE PHYSICIAN FORGOT TO ADMINISTRATE HEPARIN BEFORE DEVICE INSERTION AND HE NOTICED IT AFTER INSERTING THE INTRODUCER SHEATH. THE PHYSICIAN THOUGHT IT WAS A CAUSE OF THROMBUS FORMATION ON THE RIGHT SIDE. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Insufficient Information

  MAUDE report 21931825 ↗
• InjuryApr 29, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2012, THIS PATIENT UNDERWENT AN ENDOVASCULAR TREATMENT FOR ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESIS. ON (B)(6) 2016, TRANSCATHETER ARTERIAL EMBOLIZATION FOR A TYPE II ENDOLEAK WAS PERFORMED. (THIS EVENT HAS BEEN SEPARATELY REPORTED UNDER REPORT NUMBER 3007284313-2025-03941.) ON (B)(6) 2017, AS A FURTHER REINTERVENTION, AN OPEN ANEURYSMORRHAPHY WAS PERFORMED FOR ANEURYSM ENLARGEMENT DUE TO REMAINING TYPE II ENDOLEAK. THE DEVICES STILL REMAINED IN THE PATIENT. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Aneurysm expansion; Clinical Endoleak

  MAUDE report 21931793 ↗
• InjuryApr 29, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2012, THIS PATIENT UNDERWENT AN ENDOVASCULAR TREATMENT FOR ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESIS. ON (B)(6) 2016, TRANSCATHETER ARTERIAL EMBOLIZATION FOR A TYPE II ENDOLEAK WAS PERFORMED. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Clinical Endoleak

  MAUDE report 21931774 ↗
• InjuryDec 6, 2023Patient-Device Incompatibility; Patient-Device Incompatibility

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2011, THIS PATIENT UNDERWENT AN ENDOVASCULAR TREATMENT FOR ABDOMINAL AORTIC ANEURYSM (AAA) USING GORE® EXCLUDER® AAA ENDOPROSTHESES. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2017, A NEW ANEURYSM LESION WAS FOUND IN THE LEFT INTERNAL ILIAC ARTERY (IIA; OUTSIDE THE EXCLUDER TREATMENT AREA). COIL-EMBOLIZATION WAS PERFORMED FOR THE LEFT IIA. IN SEPTEMBER 2020, THE IIA ANEURYSM WAS ENLARGED TO 45 MM. IN OCTOBER 2023, THE IIA ANEURYSM WAS ENLARGED TO 50 MM. ON (B)(6) 2023, A REINTERVENTION WAS PERFORMED TO TREAT THE GROWING ANEURYSM. A TYPE II ENDOLEAK FROM THE ILIAC CIRCUMFLEX ARTERY WAS FOUND COMMUNICATING WITH LUMBAR ARTERY AROUND THE L3 LEVEL; THEREFORE, THE ENDOLEAK FLOW WENT INTO THE AAA. IT RESULTED IN THE ANEURYSM ENLARGEMENT. NBCA-EMBOLIZATION WAS PERFORMED FOR THE AAA AND AN ADDITIONAL CONTRALATERAL LEG WAS PLACED IN THE LEFT SIDE. THE TREATMENT AREA WAS EXTENDED INTO THE EXTERNAL ILIAC ARTERY. THE PATIENT TOLERATED THE PROCEDURE. THE AAA ENLARGEMENT DUE TO TYPE II ENDOLEAK WAS RELATED TO THE EXCLUDER; HOWEVER, THE NEW IIA ANEURYSM LESION WAS NOT RELATED. IT IS UNKNOWN WHEN TYPE II ENDOLEAK WAS FOUND. BASED ON THE

  Patient problems: Clinical Endoleak

  MAUDE report 18274853 ↗
• InjurySep 30, 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 ENDOPROSTHESES. AT THE FINAL ANGIOGRAPHY, A TYPE IIIA ENDOLEAK OR A POSSIBLE PROXIMAL TYPE I ENDOLEAK WAS SUSPECTED. AFTER TOUCH-UP BALLOONING, A ENDOLEAK STILL REMAINED BUT THE PROCEDURE WAS COMPLETED. ON AN UNKNOWN DATE, ANEURYSM ENLARGEMENT WAS CONFIRMED. ON (B)(6) 2021, A REINTERVENTION WAS PERFORMED. DURING THE REINTERVENTION, THE PHYSICIAN DETERMINED THE SUSPECTED ENDOLEAK WAS A PROXIMAL TYPE I ENDOLEAK, SO TWO STENT GRAFTS WERE IMPLANTED INTO THE PROXIMAL NECK. THE ENDOLEAK WAS RESOLVED AND THE PROCEDURE WAS COMPLETED.

  Patient problems: Aneurysm

  MAUDE report 12555280 ↗
• InjuryJun 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2013, A PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN INFLAMMATORY ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESES. DURING THE PROCEDURE, A TYPE II ENDOLEAK FROM INFERIOR MESENTERIC ARTERY WAS OBSERVED AND THE PHYSICIAN ELECTED TO MONITOR THE PATIENT. ON (B)(6) 2021, A REINTERVENTION WAS PERFORMED TO TREAT A POSSIBLE TYPE II FROM THE LEFT INTERNAL ILIAC ARTERY, WHEREBY COIL EMBOLIZATION IN THE LEFT INTERNAL ILIAC ARTERY WAS PERFORMED.

  Patient problems: Aneurysm

  MAUDE report 11958398 ↗
• InjuryNov 9, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PER (B)(6) - PATIENT HAD A EXCLUDER IMPLANTED IN 2017, THE PATIENT DEVELOPED A COMMON ILIAC ARTERY ANEURISM WHICH NEEDED TO BE COVERED WITH ANOTHER CARDIAC LIMB, AND HAD TO EMBOLIZE THE ILIAC ARTY AND EXTEND THE LIMB IN TO THE EXTERNAL ILIAC ARTERY.

  Patient problems: Complaint, Ill-Defined

  MAUDE report 10809260 ↗
• InjuryJul 12, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2010, THE PATIENT WAS IMPLANTED WITH GORE® EXCLUDER® AAA ENDOPROSTHESES TO TREAT AN ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT DURING A ROUTINE FOLLOW UP VISIT, IMAGES (DATE AND MODALITY IS UNKNOWN) REVEALED AN UNKNOWN ENDOLEAK. ON (B)(6) 2019, THE PHYSICIAN REINTERVENED. A PROXIMAL TYPE I ENDOLEAK AND A DISTAL TYPE I ENDOLEAK (UNKNOWN WHICH CONTRALATERAL LEG ENDOPROSTHESIS HAD THE DISTAL ENDOLEAK) WAS NOTED. THE PHYSICIAN IMPLANTED AN AORTIC EXTENDER ENDOPROSTHESIS TO TREAT THE PROXIMAL TYPE I ENDOLEAK AND A CONTRALATERAL LEG ENDOPROSTHESIS TO TREAT THE DISTAL TYPE I ENDOLEAK. THE CAUSE OF THE ENDOLEAKS IS UNKNOWN, HOWEVER, BOTH ENDOLEAKS WERE RESOLVED. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Aneurysm

  MAUDE report 8784761 ↗
• InjuryFeb 1, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2010, THE PATIENT UNDERWENT ENDOVASCULAR REPAIR OF AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESES. IT WAS REPORTED THE EXCLUDER® AAA ENDOPROSTHESES WERE EXPLANTED (B)(6) 2019. THE DEVICES WERE EXPLANTED DUE TO PERSISTENT TYPE II ENDOLEAKS WITH ANEURYSM GROWTH (AMOUNT UNKNOWN) AND A POTENTIAL TYPE I ENDOLEAK. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Aneurysm

  MAUDE report 8299431 ↗
• InjuryNov 21, 2018Patient-Device Incompatibility; Patient-Device Incompatibility

  ON (B)(6) 2013, THE PATIENT UNDERWENT ENDOVASCULAR REPAIR OF AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESES. TRUNK-IPSILATERAL LEG (PXT261412/(B)(4)) AND TWO CONTRALATERAL LEG COMPONENTS WERE SUCCESSFULLY DEPLOYED. THE PATIENT TOLERATED THE PROCEDURE. LATER IN A FOLLOW-UP STUDY, A TYPE II ENDOLEAK WAS CONFIRMED. ANEURYSM DIAMETER INCREASED UP TO 70MM. AS ANEURYSM DIAMETER AT THE TIME OF INITIAL IMPLANT PROCEDURE WAS NOT AVAILABLE, EXACT AMOUNT OF ENLARGEMENT WAS UNKNOWN. ON (B)(6) 2018, FIRST-STAGE REINTERVENTION WAS PERFORMED WHEREBY A CONTRALATERAL LEG COMPONENT AND A BARE-METAL STENT WERE IMPLANTED IN THE RIGHT EXTERNAL ILIAC ARTERY. THE RIGHT INTERNAL ILIAC ARTERY WAS INTENTIONALLY EMBOLIZED. ON (B)(6) 2018, SECOND-STAGE REINTERVENTION WAS PERFORMED WHEREBY A CONTRALATERAL LEG COMPONENT AND A BARE-METAL STENT WERE IMPLANTED IN THE LEFT EXTERNAL ILIAC ARTERY. THE LEFT INTERNAL ILIAC ARTERY WAS INTENTIONALLY EMBOLIZED. TYPE II ENDOLEAK WAS RESOLVED, AND THE PATIENT TOLERATED THE REINTERVENTION PROCEDURE.

  Patient problems: Aneurysm

  MAUDE report 8098041 ↗
• InjuryOct 16, 2018Patient-Device Incompatibility; Patient-Device Incompatibility

  ON AN UNKNOWN DATE IN 2009, A PATIENT UNDERWENT ENDOVASCULAR SURGERY USING GORE® EXCLUDER® AAA ENDOPROSTHESES. ON AN UNKNOWN DATE IN 2012, THE PATIENT PRESENTED TO THE HOSPITAL DUE TO DEEP THROMBOSIS VENOUS WHICH WERE REPORTEDLY MANAGED WITH ANTICOAGULANTS. ON AN UNKNOWN DATE IN 2012, THE PATIENT REPORTEDLY PRESENTED WITH WEAKNESS, AS WELL AS PAIN IN THE LEG AND BACK. IMAGING REPORTEDLY IDENTIFIED A RETROPERITONEAL COLLECTION OF BLOOD. IT WAS REPORTED THROUGH A RETROPERITONEAL ACCESS THE CLOTS WERE COLLECTED. IT WAS NOTED THAT THE ORIGIN OF THE BLEEDING IS SUSPECTED TO BE A PSEUDO ANEURYSM. IT WAS REPORTED THE PSEUDO ANEURYSM WAS TREATED BY AN ILIAC LIGATURE. AN AXILO-FEMORAL BYPASS WAS ALSO REPORTEDLY UNSUCCESSFULLY PERFORMED. THE PATIENT THEN REPORTEDLY UNDERWENT AN AMPUTATION OF THE LEFT LEG LEAVING 10CM OF THE PATIENT¿S FEMUR. IT WAS REPORTED THE PATIENT DEVELOPED A CUTANEOUS FISTULA. THE PATIENT REPORTEDLY HAD COLONIZATION OF BACTERIA DUE TO THE FISTULA AS THE INCISION IS ABOVE THE RETROPERITONEAL ACCESS. ON AN UNKNOWN DATE IN 2017, IMAGING SHOWED A CUTANEOUS FISTULA AND A SUSPECTED TYPE III ENDOLEAK.

  Patient problems: Thrombus

  MAUDE report 7972180 ↗
• InjuryOct 10, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2013, THE PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE TO REPAIR AN ABDOMINAL AORTIC ANEURYSM USING A GORE® EXCLUDER® AAA ENDOPROSTHESIS (PXT261412/ (B)(4)). THE PROCEDURE WAS COMPLETED WITHOUT ANY REPORTED ISSUES AND THE PATIENT TOLERATED THE PROCEDURE. IN (B)(6) 2017 (DATE UNKNOWN), A FOLLOW UP EXAMINATION REVEALED AN ENDOLEAK THOUGHT TO BE A PROXIMAL TYPE I OR TYPE III ENDOLEAK. IN (B)(6) 2018 (DATE UNKNOWN), A FOLLOW UP EXAMINATION REVEALED THAT THE ENDOLEAK REMAINED. ON (B)(6) 2018, AN AORTIC EXTENDER COMPONENT WAS PLACED IN THE PROXIMAL PART OF THE TRUNK-IPSILATERAL LEG COMPONENT. IT WAS CONFIRMED THAT THE ENDOLEAK WAS RESOLVED. THE PATIENT TOLERATED THE PROCEDURE. IT WAS REPORTED THAT THE TRUNK-IPSILATERAL LEG COMPONENT WAS THOUGHT TO BE MIGRATED DISTALLY (APPROXIMATELY 10 MM) GRADUALLY SINCE THE PROXIMAL NECK WAS ANGULATED. REPORTEDLY THE MIGRATION CONTRIBUTED TO THE ENDOLEAK. THEREFORE, THE ENDOLEAK IS THOUGHT TO BE PROXIMAL TYPE I INSTEAD OF TYPE III.

  Patient problems: Aneurysm

  MAUDE report 7954214 ↗
• InjurySep 10, 2018Patient-Device Incompatibility; Patient-Device Incompatibility

  ON (B)(6) 2007, THIS PATIENT UNDERWENT ENDOVASCULAR REPAIR OF AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESIS. AT THE TIME OF REPAIR THE ANEURYSM MEASURED 6.5 CM. THE PATIENT WAS THEN LOST TO FOLLOW UP. ON (B)(6) 2018, THE PATIENT HAD A FOLLOW UP EXAMINATION WHERE IT WAS REVEALED THAT THE ANEURYSM MEASURED 11.5 CM. NON-CONTRAST COMPUTED TOMOGRAPHY SHOWED WHAT APPEARED TO BE A PROXIMAL TYPE I ENDOLEAK AT THE PROXIMAL NECK, AND DISTAL TYPE I ENDOLEAKS FROM BOTH COMMON ILIAC ARTERIES. A REINTERVENTION IS PLANNED WHERE THE PHYSICIAN STATED HE WILL COIL THE LEFT HYPOGASTRIC ARTERY, THEN EXTEND BOTH ILIAC ARTERIES, AS WELL AS SNORKEL THE LEFT RENAL ARTERY AND PLACE A COOK AORTIC CUFF AT THE PROXIMAL NECK.

  Patient problems: No Code Available

  MAUDE report 7861598 ↗

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