GORE EXCLUDER AAA Endoprosthesis PXC141400Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00733132609963), received between Sep 11, 2018 and Mar 2, 2026 — classified as 1 death, 12 injuries.

The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (2 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.

• InjuryMar 2, 2026Migration

  ON (B)(6) 2015, THIS PATIENT UNDERWENT PLANNED ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM AND WAS IMPLANTED WITH GORE® EXCLUDER® AAA ENDOPROSTHESIS DEVICES. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2025, THE PATIENT UNDERWENT COMPUTERIZED AXIAL TOMOGRAPHY (CAT) SCAN IMAGING WHICH SHOWED ANEURYSMAL DILATATION DISTAL TO THE ORIGINALLY IMPLANTED LIMBS ON BOTH SIDES. IT IS UNKNOWN IF THE LIMBS MIGRATED PROXIMALLY FROM THE ORIGINAL PLACEMENT, HOWEVER THE RIGHT LIMB IS CURRENTLY 21 MM PROXIMAL TO THE INTERNAL ILIAC ARTERY AND THE LEFT LIMB IS 45 MM PROXIMAL TO THE INTERNAL ILIAC ARTERY. ON (B)(6) 2025, THE PATIENT WAS BROUGHT IN FOR RE-INTERVENTION AND A GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS (IBE) AND A GORE® VIABAHN® VBX BALLOON EXPANDABLE DEVICES WERE IMPLANTED ON BOTH SIDES. A GORE® EXCLUDER® CONTRALATERAL LEG COMPONENT WAS ALSO IMPLANTED ON THE LEFT SIDE LEFT SIDE PRIOR TO IBE PLACEMENT TO EXTEND THE PRIOR LIMB AND CREATE A LANDING ZONE. THIS SUCCESSFULLY EXCLUDED THE COMMON ILIAC ANEURYSMS. THE PROCEDURE WAS WELL TOLERATED AND WITHOUT COMPLICATION.

  Patient problems: Aneurysm

  MAUDE report 24483794 ↗
• 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 (B)(6) 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 LEG A

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

  MAUDE report 18153606 ↗
• InjuryJul 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE THROUGH THE GLOBAL REGISTRY FOR ENDOVASCULAR AORTIC TREATMENT (GREAT 10-11): ON (B)(6), 2014 THE PATIENT UNDERWENT ENDOVASCULAR REPAIR OF AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESES. THE PATIENT TOLERATED THE PROCEDURE. FOLLOW UP COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) EXAMINATION ON (B)(6), 2015 SHOWED THE ANEURYSM MEASURED 63.0 M FOLLOW UP COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) EXAMINATION ON (B)(6), 2015 SHOWED THE ANEURYSM MEASURED 75.0 MM. FOLLOW UP COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) EXAMINATION ON (B)(6), 2018 SHOWED THE ANEURYSM MEASURED 89.0 MM. FOLLOW UP COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) EXAMINATION ON (B)(6), 2019 SHOWED THE ANEURYSM MEASURED 88.0 MM. FOLLOW UP COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) EXAMINATION ON (B)(6), 2020 SHOWED THE ANEURYSM MEASURED 94.0 MM. FOLLOW UP COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) EXAMINATION ON (B)(6), 2022 SHOWED THE ANEURYSM MEASURED 99.0 MM. FOLLOW UP COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) EXAMINATION ON (B)(6), 2023 SHOWED THE ANEURYSM MEASURED 106.0 MM. ON (B)(6), 2023, THE PATIENT WAS REPORTED TO SUFFER FROM MESENTERIC ISCHEMIA. THE PATIENT WAS TREATED WITH LEF

  Patient problems: Ischemia

  MAUDE report 17415497 ↗
• InjuryMay 4, 2023Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  ON (B)(6), 2014, THE PATIENT WAS IMPLANTED WITH GORE® EXCLUDER® AAA ENDOPROSTHESES TO TREAT AN ABDOMINAL AORTIC ANEURYSM. REPORTEDLY, PRE-TREATMENT COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) SHOWED THAT THE MAXIMUM DIAMETER OF THE AORTIC ANEURYSM/LESION WAS 100MM. THE RIGHT COMMON ILIAC ARTERY ANEURYSM WAS 15MM. PATIENT TOLERATED THE PROCEDURE. ON (B)(6), 2014, THE FOLLOW UP CTA SHOWED THAT THE MAXIMUM DIAMETER OF THE AORTIC ANEURYSM/LESION WAS 96MM. ON (B)(6), 2015, A TYPE II ENDOLEAK WAS DETERMINED. NO INTERVENTION WAS DONE BECAUSE IT WASN'T NEEDED AT THAT TIME. FROM (B)(6), 2015 TO (B)(6), 2022 THE FOLLOW UP SCANS DETERMINED THAT THE MAXIMUM DIAMETER OF THE AORTIC ANEURYSM/LESION INCREASED IN SIZE FROM 99MM TO 119MM. THE RIGHT COMMON ILIAC ARTERY ANEURYSM WAS 25MM. ON (B)(6), 2022, THE PATIENT UNDERWENT EMBOLIZATION PROCEDURE TO TREAT A TYPE II ENDOLEAK. ON AN UNKNOWN DATE IN (B)(6) 2023, THE RIGHT COMMON ILIAC ARTERY ANEURYSM WAS 28MM. ON (B)(6), 2023, A RIGHT EXTERNAL ILIAC ARTERY DISTAL TYPE I ENDOLEAK WAS DETERMINED. ACCORDING TO THE SITE, THE EVENT WAS RELATED TO AORTIC DEVICE OR PROCEDURE. ON (B)(6), 2023, THE PATIENT UNDERWENT THE ENDOVASCULAR PROCEDURE ON THE RIGHT SIDE USING

  Patient problems: Aneurysm; Clinical Endoleak

  MAUDE report 16873180 ↗
• InjuryMay 3, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2017, THE PATIENT WAS IMPLANTED WITH GORE¿ EXCLUDER¿ AAA ENDOPROSTHESES TO TREAT AN ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT COMPUTED TOMOGRAPHY IMAGES DATED (B)(6) 2021, THE PHYSICIAN NOTED DISEASE PROGRESSION AND GROWTH (NEW ANEURYSM) OF THE LEFT COMMON ILIAC ARTERY DISTAL TO THE INITIAL DEVICE PLACEMENT WITHOUT THE PRESENCE OF AN ENDOLEAK. THE FLOW LUMEN WAS STABLE. THERE WAS NO ANEURYSM SAC ENLARGEMENT. ON (B)(6) 2021, THE PHYSICIAN DECIDED TO COIL EMBOLIZE THE LEFT INTERNAL ILIAC ARTERY AND EXTEND THE ORIGINAL ENDOGRAFT (PXC141400/15929867) INTO THE LEFT EXTERNAL ILIAC ARTERY TO ACHIEVE SEAL AND TREAT THE DISEASE PROGRESSION. THE PROCEDURE WENT WELL, AND THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Aneurysm

  MAUDE report 11766412 ↗
• InjuryDec 8, 2020Adverse 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 ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM USING GGORE® EXCLUDER® AAA ENDOPROSTHESIS. ON AN UNKNOWN DATE, IT WAS OBSERVED A DISTAL TYPE I ENDOLEAK, AND ANEURYSM ENLARGEMENT OF THE RIGHT COMMON ILIAC ARTERY. ON (B)(6) 2020, REINTERVENTION FOR PLACING ADDITIONAL STENT GRAFT WAS PERFORMED. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Aneurysm

  MAUDE report 10969101 ↗
• InjuryOct 19, 2020Patient-Device Incompatibility; Patient-Device Incompatibility

  ON AN UNKNOWN DATE IN 2014 THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESES. THE ANEURYSM REPORTEDLY MEASURED 5.5CM. ON (B)(6) 2020 THE FIELD SALES ASSOCIATE WAS MADE AWARE OF ANEURYSM GROWTH. THE ANEURYSM REPORTEDLY MEASURED 6.9CM. REPORTEDLY THERE WAS NO EVIDENCE OF AN ENDOLEAK. ON (B)(6) 2020 THE PATIENT UNDERWENT REINTERVENTION TO TREAT THE ANEURYSM ENLARGEMENT. AN AORTIC EXTENDER COMPONENT AND TWO ADDITIONAL CONTRALATERAL LEG COMPONENTS WERE USED TO RELINE THE ORIGINAL DEVICE SYSTEM. THE PHYSICIAN REPORTEDLY SUSPECTED THAT THE ANEURYSM ENLARGEMENT MAY BE DUE TO ENDOTENSION. THERE WERE NO FURTHER REPORTED ISSUES. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Aneurysm

  MAUDE report 10699787 ↗
• InjuryAug 10, 2020Adverse 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 ABDOMINAL AORTIC ANEURYSMS USING GORE® EXCLUDER® AAA ENDOPROSTHESES. ON AN UNKNOWN DATE, ENLARGEMENT OF THE ANEURYSM DIAMETER (AMOUNT UNKNOWN) AND A DISTAL TYPE I ENDOLEAK FROM THE LEFT LEG WERE NOTED. THE DEVICE IMPLANTED ON LEFT DISTAL SIDE WAS EITHER PXC141400/11180177 OR PXC141400/11180180, NOT DETERMINED BY THE REPORTER. IT WAS ALSO CONFIRMED THAT THERE WAS LACK OF APPOSITION OF PXA280300/10067062 AT THE INNER CURVATURE OF THE PROXIMAL AORTIC NECK. ON (B)(6) 2020, RE-INTERVENTION WAS PERFORMED. THE LEFT INTERNAL ILIAC ARTERY WAS COIL EMBOLIZED AND AN ADDITIONAL STENT GRAFT WAS IMPLANTED IN THE LEFT EXTERNAL ILIAC ARTERY. THE DISTAL TYPE I ENDOLEAK WAS NO LONGER DETECTABLE. DURING THE OPERATION, A PROXIMAL TYPE I ENDOLEAK WAS NOT IDENTIFIED, HOWEVER AN ADDITIONAL STENT GRAFT WAS IMPLANTED IN THE PROXIMAL NECK TO SOLVE THE LACK OF APPOSITION. THE PHYSICIAN COMMENTED THAT THE PROXIMAL NECK OF THE PATIENT WAS ANGLED, SO THE LACK OF APPOSITION IN THE PROXIMAL SIDE WAS CONSIDERED TO BE DUE TO THE PATIENT¿S ANATOMY.

  Patient problems: Aneurysm

  MAUDE report 10385542 ↗
• InjuryJul 22, 2020Adverse 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 COMPUTED TOMOGRAPHY (CT) IMAGES DATED (B)(6) 2020, REVEALED THE PATIENT HAS A POSSIBLE UNKNOWN TYPE ENDOLEAK. THE CAUSE FOR THE ENDOLEAK IS UNKNOWN. ON (B)(6) 2020, THE PHYSICIAN REINTERVENED AND PERFORMED AN ANGIOGRAM. THERE WAS NO VISIBLE ENDOLEAK PRESENT. HOWEVER, THE PHYSICIAN CHOSE TO RE-INTERVENE AND IMPLANTED A CONTRALATERAL LEG ENDOPROSTHESIS TO EXTEND THE CURRENTLY IMPLANTED CONTRALATERAL LEG ENDOPROSTHESIS (PXC141400/7316347) FOR PREVENTIVE MEASURES. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Aneurysm

  MAUDE report 10309043 ↗
• InjuryMar 26, 2020Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  ON (B)(6) 2016, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AN AORTIC ANEURYSM MEASURING 73.0MM. ALL COMPONENTS WERE SUCCESSFULLY IMPLANTED WITH NO REPORTED USE ISSUES. PATIENT TOLERATED THE PROCEDURE AND WAS DISCHARGED TO HOME ON (B)(6) 2016. ON (B)(6) 2016, COMPUTED TOMOGRAPHY (CT) PERFORMED BY THE SITE REPORTED THE MAXIMUM ANEURYSM DIAMETER MEASURED 83MM. A TYPE II ENDOLEAK INVOLVING A LUMBAR ARTERY WAS DETERMINED. NO ADDITIONAL SEQUELAE WAS REPORTED. ON (B)(6) 2016, CT PERFORMED BY THE SITE DETERMINED THE MAXIMUM ANEURYSM DIAMETER MEASURED 81MM AND A TYPE II ENDOLEAK WAS CONFIRMED. THE EVENT WAS ONGOING, NO ACTION WAS TAKEN AND NO TREATMENT IS PLANNED. A SEARCH IN THE DATABASE DOCUMENTED THE RESOLUTION OF THE ENDOLEAK ON (B)(6) 2017 WITHOUT SEQUELAE. NO EVIDENCE OF ANEURYSM ENLARGEMENT AND NO REPORT OF ADDITIONAL PROCEDURE TO TREAT THE ENDOLEAK WAS NOTED (COVERED BY EVENT# (B)(6)). ON (B)(6) 2018, COMPUTED TOMOGRAPHY (CT) PERFORMED BY THE SITE REPORTED THE MAXIMUM ANEURYSM DIAMETER MEASURED 90 MM. NO ADVERSE EVENTS WERE REPORTED AT THIS VISIT. ON (B)(6) 2019, COMPUTED TOMOGRAPHY (CT) PERFORMED BY THE SITE REPORTED THE MAXIMUM ANEURYSM DIAMETER MEASURED 98 MM. NO ADVERSE E

  Patient problems: Aneurysm

  MAUDE report 9886522 ↗
• InjuryJan 13, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REPORTED TO HAVE BEEN IMPLANTED WITH A GORE® EXCLUDER® AAA ENDOPROSTHESIS ON (B)(6) 2012. ON (B)(6) 2019, A POSSIBLE PROXIMAL TYPE I ENDOLEAK WITH ANEURYSM ENLARGEMENT WAS REPORTED. THE PHYSICIAN WAS UNABLE TO DETERMINE THE LOCATION OF THE ENDOLEAK, BUT THE ANEURYSMAL SAC WAS GROWING. THE PHYSICIAN PLANNED A REINTERVENTION TO RELINE WITH AN AORTIC CUFFS AND TWO LIMBS. REINTERVENTION OCCURRED ON (B)(6) 2019.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9580830 ↗
• InjuryDec 18, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2015, THIS PATIENT UNDERWENT AN ENDOVASCULAR REPAIR OF A RIGHT COMMON ILIAC ARTERY ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESIS CONTRALATERAL LEG COMPONENT. THE SITE REPORTS THAT THERE WAS PROGRESSIVE ANEURYSM SAC ENLARGEMENT DUE TO A TYPE II ENDOLEAK, ALTHOUGH ANEURYSM DIAMETER MEASUREMENTS WERE NOT PROVIDED. ON (B)(6) 2019, PERCUTANEOUS ENDOLEAK REPAIR WITH COILING WAS PERFORMED. THE PATIENT TOLERATED THE PROCEDURE AND THE ENDOLEAK WAS RESOLVED.

  Patient problems: Aneurysm

  MAUDE report 9488981 ↗
• InjurySep 11, 2018Patient-Device Incompatibility; Patient-Device Incompatibility

  ON (B)(6) 2017, THE PATIENT WAS IMPLANTED WITH FIVE GORE® EXCLUDER® AAA ENDOPROSTHESES ((B)(4)) TO TREAT AN ABDOMINAL AORTIC ANEURYSM. ON AN UNKNOWN DATE, FOLLOW-UP IMAGING REVEALED A PERSISTENT TYPE II ENDOLEAK WITH ANEURYSMAL ENLARGEMENT (AMOUNT UNKNOWN). ON (B)(6) 2018, THE PATIENT UNDERWENT COIL-EMBOLIZATION OF THE INFERIOR MESENTERIC ARTERY (IMA) TO TREAT THE TYPE II ENDOLEAK. HOWEVER, THE ENDOLEAK REPORTEDLY REMAINED AFTER THE PROCEDURE. ON (B)(6) 2015, A TYPE II ENDOLEAK ORIGINATING FROM THE IMA AND LUMBAR ARTERIES WAS CONFIRMED BY COMPUTED TOMOGRAPHIC ANGIOGRAPHY. ON THIS DATE, THE PATIENT UNDERWENT AN OPEN PROCEDURE WHEREBY THE STENT GRAFT COMPONENTS WERE EXPLANTED AND THE VASCULATURE WAS SURGICALLY REPAIRED. THE ENDOLEAK WAS RESOLVED AND THE PATIENT TOLERATED THE PROCEDURE. THE EXPLANTED DEVICES WERE DISCARDED AT THE FACILITY AND, THEREFORE, WERE NOT AVAILABLE FOR ANALYSIS BY GORE.

  Patient problems: No Code Available

  MAUDE report 7865511 ↗

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)