GORE EXCLUDER AAA Endoprosthesis PXT261418Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00733132610242), received between Mar 4, 2019 and Jul 22, 2024 — classified as 1 death, 7 injuries.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (4 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.

• InjuryJul 22, 2024Device-Device Incompatibility; Device-Device Incompatibility

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2009, THE PATIENT UNDERWENT AN ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESES. A TRUNK IPSILATERAL LEG ENDOPROSTHESIS AND A CONTRALATERAL LEG WERE IMPLANTED. THE CONTRALATERAL LEG WAS IMPLANTED IN THE LEFT LIMB. ON (B)(6) 2024, THE PATIENT CAME TO THE HOSPITAL COMPLAINING A STOMACHACHE. A CT REVEALED THE ABDOMINAL AORTIC ANEURYSM RUPTURE AND SUSPECTED A DISTAL TYPE I ENDOLEAK FROM THE RIGHT LEG, A DISTAL TYPE I ENDOLEAK FROM THE LEFT LEG, A PROXIMAL ENDOLEAK AND/OR A TYPE IIIA ENDOLEAK. REPORTEDLY, THE PATIENT VITAL SIGNS ARE STABLE. AN URGENT EVAR WAS PERFORMED TO TREAT THEM. A CONTRALATERAL LEG ENDOPROSTHESIS WAS IMPLANTED TO EXTEND THE RIGHT LEG BECAUSE THE DISTAL TYPE I ENDOLEAK FROM THE RIGHT LEG WAS SUSPECTED. IT WAS NOT CONFIRMED AN OBVIOUS ENDOLEAKS FROM THE PROXIMAL OF THE TRUNK AND THE DISTAL OF THE LEFT LEG. IT WAS OBSERVED THAT A GATE OF TRUNK IPSILATERAL LEG ENDOPROSTHESIS AND A CONTRALATERAL LEG ENDOPROSTHESIS ARE DISCONNECTED. THEREFORE, AN ADDITIONAL CONTRALATERAL LEG ENDOPROSTHESIS WAS IMPLANTED TO RELINE THE GATE AND THE CONTRALATERAL LEG ENDOPROSTHESIS. AN ANGIOGRAPHY R

  Patient problems: Aneurysm expansion; Clinical Endoleak; Ruptured Aneurysm

  MAUDE report 19790461 ↗
• DeathNov 16, 2023Obstruction of Flow; Adverse Event Without Identified Device or Use Problem; Obstruction of Flow; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2010, THE PATIENT UNDERWENT AN ENDOVASCULAR ABDOMINAL AORTIC ANEURYSM (AAA) REPAIR UTILIZING A GORE® EXCLUDER® AAA ENDOPROSTHESIS (PXC141400 AND PXT261418). PATIENT HAS HAD ANNUAL ABDOMINAL U/S SURVEILLANCE WHICH HAVE SHOWN NO DEFINITIVE LEAKS, HOWEVER, THE AAA HAS SHOWN A GRADUAL INCREASE IN SIZE OVER THE LAST 10 YEARS. THIS YEAR, THE SURVEILLANCE REVEALED A 5.4CM AAA WHICH IS A 4MM INCREASE IN SIZE FROM LAST YEAR'S SCAN. A CTA WAS ORDERED (DATE UNKNOWN) WHICH REVEALED THE AAA WAS CLOSER TO 5.7CM. AGAIN, THERE WAS NO DEFINITIVE LEAKS SEEN BUT IN REVIEW WITH A FIELD SALES ASSOCIATES (FSA) THERE MAY BE A WISP OF CONTRAST COMING FROM THE TOP OF THE GRAFT ON THE RIGHT SIDE AND THE RIGHT LIMB IS BARELY SEATED IN THE ILIAC ARTERY. PATIENT DENIES ABDOMINAL PAIN. ON OCTOBER 20, 2023, FSA WAS NOTIFIED THAT PHYSICIAN PLANS TO INTERVENE AS THERE MAY BE A POSSIBLE TYPE 1A ENDOLEAK THAT THEY SUSPECTED DUE TO EXPANDING ANEURYSM BUT UNKNOWN IF ITS COMING FROM THE TRUNK IPSILATERAL OR CONTRALATERAL LEG. ON (B)(6) 2023, THE PATIENT WAS BROUGHT IN FOR A REINTERVENTION PROCEDURE BY EXTENDING PROXIMALLY FROM THE BIFURCATED STENT GRAFTS (TRUNK IPSILATERAL

  Patient problems: Aneurysm expansion; Clinical Endoleak; High Blood Pressure/ Hypertension

  MAUDE report 18154698 ↗
• InjuryOct 31, 2023Patient-Device Incompatibility; Patient-Device Incompatibility

  ON (B)(6), 2013, THIS PATIENT UNDERWENT AN ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESES. ON OCTOBER 13, 2023, A REINTERVENTION WAS PERFORMED FOR A SUSPECTED PROXIMAL TYPE I ENDOLEAK. AN ADDITIONAL STENT GRAFT WAS IMPLANTED INTO THE PROXIMAL SIDE AND THE PROCEDURE WAS COMPLETED. THE PHYSICIAN REPORTED THAT THE PROXIMAL TYPE I ENDOLEAK WAS ATTRIBUTED TO THE DILATION OF THE PROXIMAL NECK.

  Patient problems: Clinical Endoleak

  MAUDE report 18044652 ↗
• InjuryJul 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FIELD SALES ASSOCIATE REPORTED THE FOLLOWING: ON (B)(6) 2008, THE PATIENT WAS IMPLANTED WITH A GORE® EXCLUDER® AAA ENDOPROSTHESES TO TREAT AN ABDOMINAL AORTIC ANEURYSM. THE PATIENT TOLERATED THE PROCEDURE. IT WAS REPORTED THAT IMAGES (MODALITY IS UNKNOWN AND IMAGES WERE IN (B)(6) OF 2022), REVEALED A POSSIBLE ENDOLEAK (TYPE II ENDOLEAK OR PROXIMAL TYPE I ENDOLEAK). REPORTEDLY THERE IS ENLARGEMENT IN THE ANEURYSM SAC (AMOUNT OF GROWTH IS UNKNOWN). IN 2015 THE ANEURYSM SAC MEASURED 6.9CM X 7.3 CM, CURRENT IMAGES DATED (B)(6) 2022 REVEALED THE ANEURYSM SAC MEASURED 9.5CM X 10.9CM. A REINTERVENTION IS PLANNED FOR (B)(6) 2022.

  Patient problems: Aneurysm

  MAUDE report 15076564 ↗
• InjuryOct 11, 2021Patient Device Interaction Problem; Migration; Patient Device Interaction Problem; Migration

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2013, A PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESES. ON UNKNOWN DATE BUT IN 2019, AT A FOLLOW-UP, A COMPUTED TOMOGRAPHY REVEALED A ENLARGEMENT OF THE PROXIMAL NECK. ON UNKNOWN DATE BUT IN (B)(6) 2021, AT A FOLLOW-UP, A COMPUTED TOMOGRAPHY REVEALED A MIGRATION OF THE MAIN BODY AND A ENLARGEMENT OF THE ANEURYSM. ON (B)(6) 2021, A BIFURCATED GRAFT REPLACEMENT WAS PERFORMED SUCCESSFULLY. THE PHYSICIAN STATED THAT THE PROXIMAL NECK WAS ORIGINALLY WITH EXCESSIVE THROMBUS AND IN POOR CONDITION, AND THAT THE NECK HAD ENLARGEMENT, LEADING TO THE MIGRATION. BASED ON THIS, THE PHYSICIAN DECIDED TO PERFORM THE GRAFT REPLACEMENT.

  Patient problems: Aneurysm

  MAUDE report 12605974 ↗
• InjuryJul 8, 2021Patient-Device Incompatibility; Patient-Device Incompatibility

  FURTHER EXAMINATION WAS PERFORMED ON THE EXPLANTED GRAFTS AND MATERIAL DISRUPTIONS WERE FOUND WHICH WERE LIKELY DUE TO IN-VIVO WEAR BY INTERACTION WITH THE DISEASED ARTERY AND ANATOMICAL BENDS WITH PHYSIOLOGIC MOTION DURING THE TIME PERIOD THE GRAFTS WERE IMPLANTED IN THE PATIENT.

  Patient problems: Aneurysm

  MAUDE report 12138967 ↗
• InjuryMar 14, 2019Patient-Device Incompatibility; Patient-Device Incompatibility

  ON (B)(6) 2009, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM AND WAS IMPLANTED WITH GORE® EXCLUDER® AAA ENDOPROSTHESES. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2019, THE PATIENT UNDERWENT REINTERVENTION OCCURRED AND A GORE® AORTIC EXTENDER COMPONENT WAS PLACED PROXIMALLY. THE TYPE OF ENDOLEAK WAS UNABLE TO DETERMINED. AS THERE WAS ALSO BIRD BEAKING OF THE PROXIMAL END OF THE TRUNK ON THE RIGHT SIDE, A PALMAZ STENT WAS ALSO PLACED. THE PATIENT WAS REPORTED TO HAVE A SHORT ANGLED NECK (UNKNOWN IF ANGLE EXCEEDED 60 DEGREES). IT WAS ALSO REPORTED THERE WAS ENLARGEMENT OF THE ANEURYSM FROM 6 X 5.8CM IN DIAMETER ON (B)(6) 2018 TO 7.4CM IN DIAMETER ON (B)(6) 2018. AT TIME OF REINTERVENTION THE DIAMETER MEASURED 7.7 X 7.0CM. THE PATIENT TOLERATED THE PROCEDURE WELL.

  Patient problems: Aneurysm

  MAUDE report 8422954 ↗
• InjuryMar 4, 2019Patient-Device Incompatibility; Patient-Device Incompatibility

  ON (B)(6) 2010, THIS PATIENT UNDERWENT TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM WITH TWO GORE® EXCLUDER® AAA ENDOPROSTHESES AND ANOTHER MANUFACTURE¿S STENT GRAFT (ZENITH LEG COMPONENT, COOK). THE IPSILATERAL LEG OF THE TRUNK-IPSILATERAL LEG COMPONENT WAS IMPLANTED INTO THE RIGHT EXTERNAL ILIAC ARTERY AND THE RIGHT INTERNAL ILIAC ARTERY WAS COIL-EMBOLIZED. THE ILIAC EXTENDER COMPONENT WAS IMPLANTED ON THE LEFT SIDE. THE ZENITH LEG WAS IMPLANTED DISTAL TO THE ILIAC EXTENDER COMPONENT. AFTER ALL THE DEVICES WERE IMPLANTED, A PROXIMAL TYPE I ENDOLEAK WAS IDENTIFIED. POST- BALLOONING WAS PERFORMED, AND THE TYPE I ENDOLEAK WAS DIMINISHED BUT SLIGHTLY REMAINED. A TYPE II ENDOLEAK FROM AN UNKNOWN ORIGIN WAS ALSO OBSERVED. THE PROCEDURE WAS FINISHED WITH NO FURTHER TREATMENT. IT WAS REPORTED THAT THE DISTAL LEFT COMMON ILIAC ARTERY WAS ANEURYSMAL, BUT WAS NOT TREATED AT THIS TIME. ON (B)(6) 2012, THE PATIENT RECEIVED AN ADDITIONAL TREATMENT TO TREAT THE LEFT COMMON ILIAC ARTERY ANEURYSM. A GORE® EXCLUDER AAA ENDOPROSTHESIS CONTRALATERAL LEG COMPONENT WAS IMPLANTED ON THE LEFT SIDE AND EXTENDED TO THE LEFT EXTERNAL ILIAC ARTERY. THE LEFT INTERNAL ILIAC ARTERY WAS COIL-EMBOLIZED. ON UNKNOWN

  Patient problems: No Code Available

  MAUDE report 8386775 ↗

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