GORE EXCLUDER Conf AAA Endo - Aortic Extender CXA320005Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00733132650965), received between Aug 4, 2021 and Mar 12, 2026 — classified as 8 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Endoleak” (2 reports).

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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryMar 12, 2026Device Endoleak

  ON (B)(6) 2023, THE PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE TO TREAT AN ABDOMINAL AORTIC ANEURYSM UTILIZING GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS (CXT281412 AND CXT321414) AND GORE® EXCLUDER® AAA ENDOPROSTHESIS (PLL161207, PLC181200, AND PLC201000). A PARTIAL DEPLOYMENT OCCURRED WITH THE PLC181200 DURING THE INITIAL PROCEDURE, WHICH LED TO THE LEADING END OF THE CATHETER BREAKING AND REMAINING IN THE PATIENT (REFERENCE (B)(4)). ON (B)(6) 2026, THE PATIENT UNDERWENT A REINTERVENTION PROCEDURE TO TREAT A TYPE 1A ENDOLEAK ON THE CXT321414. A GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS (CXA320005) WAS IMPLANTED TO TREAT THE ENDOLEAK. REPORTEDLY, THE ENDOLEAK WAS NOT RESOLVED FOLLOWING THIS REINTERVENTION AND IT IS UNKNOWN IF THERE WAS ANEURYSM GROWTH ASSOCIATED WITH THE ENDOLEAK. THE FIELD SALES ASSOCIATE (FSA) WAS MADE AWARE ON (B)(6) 2026 THAT ON (B)(6) 2026, THE PATIENT UNDERWENT AN EXPLANT OF ALL FIVE DEVICES IMPLANTED IN THE INITIAL PROCEDURE DUE TO A PERSISTENT TYPE 1A ENDOLEAK. THE PATIENT WAS REPAIRED DURING THE EXPLANT PROCEDURE AND TOLERATED THE PROCEDURE.

  Patient problems: Clinical Endoleak

  MAUDE report 24581635 ↗
• InjuryAug 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING WAS REPORTED: ON (B)(6) 2019, THE PATIENT WAS IMPLANTED WITH GORE® EXCLUDER® AAA ENDOPROSTHESIS TO TREAT AN ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT ON (B)(6) 2025, A REINTERVENTION OCCURRED FOR PROXIMAL OF IMPLANTED DEVICE ANEURYSMAL DEGENERATION DISEASE. THE PHYSICIAN IMPLANTED A GORE® EXCLUDER® AAA ENDOPROSTHESIS AORTIC EXTENDER AND USED APTUS ANCHORS. AFTER UTILIZING THE APTUS ANCHORS, THE DEVICE MIGRATED PROXIMALLY AND PARTIALLY COVERED THE LEFT RENAL ARTERY. THE PHYSICIAN IMPLANTED A HERCULINK ELITE RENAL STENT IN THE LEFT RENAL ARTERY. THE RENAL ARTERY REMAINED PATENT, AND THE PATIENT TOLERATED THE PROCEDURE.

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

  MAUDE report 22927025 ↗
• InjuryAug 7, 2025Device Endoleak; Device Endoleak

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2024, THE PATIENT WAS TREATED EMERGENTLY FOR A RUPTURED ABDOMINAL AORTIC ANEURYSM USING GORE®EXCLUDER®AAA ENDOPROSTHESIS DEVICES. ALTHOUGH THE PATIENT HAD AN 80 DEGREE TURN IN THE PROXIMAL AORTIC NECK, DUE TO THE EMERGENT NATURE OF THE CASE A GORE®EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS TRUNK DEVICE COULD NOT BE OBTAINED. ADDITIONALLY, THE PATIENT'S ILIAC ARTERIES WERE TOO WIDE TO GET DISTAL SEAL, SO DUE TO THE EMERGENT NATURE OF THE CASE 32MM AND 36MM GORE®EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS CUFFS WERE IMPLANTED IN THE LEFT AND RIGHT ILIAC ARTERIES. AT THE TIME, THE PHYSICIAN EXPECTED THESE MEASURES TO BE SHORT-TERM FIXES. ON (B)(6) 2025, THE PATIENT UNDERWENT AN OPEN REPAIR OF THE ANEURYSM, WITH EXPLANTATION OF ALL OF THE GORE DEVICES EXCEPT FOR THE CUFF IN THE RIGHT ILIAC ARTERY (PREVIOUSLY REPORTED ON). REPORTEDLY, THERE WERE NO ACTIVE ENDOLEAKS, BUT THE PHYSICIAN WAS STILL VERY CONCERNED ABOUT THE MARGINAL NATURE OF THE PROXIMAL SEAL ZONE ON (B)(6) 2025 THE PATIENT WAS RETURNED TO THE ER AFTER PASSING OUT, WITH BLOOD PRESSURE AT 84/48. A CT SCAN REVEALED LARGE RETROPEROTINEAL HEMATOMA, AND THE PHYSICIAN PRESUMED AN ENDOLEAK,

  Patient problems: Clinical Endoleak

  MAUDE report 22738106 ↗
• InjuryJul 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING WAS REPORTED: ON (B)(6) 2023, THE PATIENT WAS IMPLANTED WITH GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS TO TREAT AN ABDOMINAL AORTIC ANEURYSM. ON (B)(6) 2024, THERE WAS A REINTERVENTION TO TREAT ANEURYSM ENLARGEMENT FOR AN UNDETERMINED ENDOLEAK. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2025, THE PHYSICIAN EXPLANTED ALL DEVICES DUE TO AN INFLAMMATORY ANEURYSM (POSSIBLY INFECTED BUT CULTURES CAME BACK NEGATIVE) AND FOR A PROXIMAL TYPE I ENDOLEAK. ANEURYSM SAC ENLARGEMENT (AMOUNT IS UNKNOWN). THE PHYSICIAN PERFORMED AN OPEN CONVERSION. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Clinical Endoleak

  MAUDE report 22639631 ↗
• InjuryFeb 25, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  ON (B)(6) 2025, THIS PATIENT UNDERWENT EMERGENT ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM RUPTURE USING GORE® EXCLUDER® AAA ENDOPROSTHESIS AND GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS. AFTER A TRUNK-IPSILATERAL LEG COMPONENT WAS DEPLOYED, THE PROXIMAL SIDE OF THE DEVICE MIGRATED AND FELL INTO THE ANEURYSM. THREE AORTIC EXTENDER COMPONENTS WERE DEPLOYED FROM DISTAL TO THE RENAL ARTERY AND THE THIRD ONE BRIDGED TO THE TRUNK-IPSILATERAL LEG COMPONENT. THE FORTH AORTIC EXTENDER COMPONENT WAS DEPLOYED FROM MORE PROXIMALLY. WHILE BALLOONING THE FORTH DEVICE, THE THIRD AORTIC EXTENDER COMPONENT MIGRATED PROXIMALLY AND SEPARATED FROM THE TRUNK-IPSILATERAL LEG COMPONENT. THE FIFTH AORTIC EXTENDER COMPONENT WAS DEPLOYED AS IT BRIDGE THE THIRD AORTIC EXTENDER COMPONENT AND THE TRUNK-IPSILATERAL LEG COMPONENT, HOWEVER, THE FIFTH ONE WAS MIGRATED PROXIMALLY. THEN THE SIXTH AORTIC EXTENDER COMPONENT WAS DEPLOYED AND SUCCESSFULLY BRIDGED TO THE TRUNK-IPSILATERAL LEG COMPONENT. REPORTEDLY, A PROXIMAL TYPE I ENDOLEAK WAS OBSERVED ON THE ANGIOGRAPHY, THE PROCEDURE WAS CONVERTED TO A SURGICAL PROCEDURE AND A Y-GRAFT REPLACEMENT WAS PERFORMED. THE PATIENT TOLERATED THE PROCEDURE. IT

  Patient problems: Clinical Endoleak

  MAUDE report 21465501 ↗
• InjuryMay 18, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON (B)(6) 2021, PATIENT UNDERWENT AN ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESES AT AN OUTSIDE FACILITY (MT. NITTANY MEDICAL CENTER). ON (B)(6) 2022, A REINTERVENTION WAS PERFORMED AT THE SAME FACILITY FOR AN ASSUMED TYPE 1A ENDOLEAK AND THREE PROXIMAL AORTIC EXTENDER COMPONENTS WERE IMPLANTED (PLA320400, CXA320005, CXA360005). THE PATIENT WAS TRANSFERRED TO UPMC ALTOONA MEDICAL CENTER AND ALL THE DEVICES WERE EXPLANTED ON (B)(6) 2023 BY DR. AL-KHOURY DUE TO A CONTINUED TYPE 1A ENDOLEAK. THE PATIENT HAD BEEN HAVING ABDOMINAL AND BACK PAIN THAT GOT PROGRESSIVELY WORSE OVER THE PAST FEW DAYS UNTIL IT BECAME UNBEARABLE. THE EXPLANT PROCEDURE WAS WELL TOLERATED AND WITHOUT COMPLICATION.

  Patient problems: Clinical Endoleak

  MAUDE report 16956994 ↗
• InjuryMar 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FIELD SALES ASSOCIATE (FSA) REPORTED THE FOLLOWING: ON (B)(6) 2023, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESES. THE PATIENT TOLERATED THE PROCEDURE. THE FSA REPORTED THAT FOLLOW UP IMAGES REVEALED A PROXIMAL TYPE I ENDOLEAK. REPORTEDLY THE PATIENT HAS A CALCIFIED ANGLED AORTIC NECK WITH 2CM OF AORTIC NECK. A REINTERVENTION ON (B)(6) 2023, THE PHYSICIAN BALLOONED THE PROXIMAL SEGMENT OF GRAFT. "THERE WAS NO OBVIOUS ENDOLEAK, BUT WE BALLOONED THE NECK". THE PHYSICIAN FEELS THERE IS NOT A TYPE 1A ENDOLEAK AND THERE IS NO ANEURYSM SAC ENLARGEMENT, THE SAC IS STABLE. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Aneurysm

  MAUDE report 16611171 ↗
• InjuryNov 16, 2022Malposition of Device; Activation, Positioning or Separation Problem; Malposition of Device; Activation, Positioning or Separation Problem

  ON (B)(6) 2022, THIS PATIENT UNDERWENT AN ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESES. REPORTEDLY, THE PHYSICIAN ATTEMPTED TO DEPLOY THE DEVICE JUST BELOW THE LEFT RENAL ARTERY, HOWEVER, THE LEFT RENAL ARTERY WAS UNINTENTIONALLY COVERED BY THE AORTIC EXTENDER COMPONENT. AN ADDITIONAL BARE STENT WAS PLACED. THERE WAS NO INFORMATION PROVIDED IF THE PATIENT¿S ANATOMY CAUSED OR CONTRIBUTED TO THE EVENT. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Aneurysm; Reduced Blood Flow

  MAUDE report 15811657 ↗
• MalfunctionAug 4, 2021Material Fragmentation; Material Fragmentation

  ON (B)(6) 2021, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESIS. DURING IMPLANTATION OF A GORE® EXCLUDER® AAA CONFORMABLE AORTIC EXTENDER ENDOPROSTHESIS, THE LEADING OLIVE BECAME DISLODGED FROM THE DELIVERY CATHETER INSIDE THE PATIENT. THE OLIVE WAS SUCCESSFULLY RETRIEVED. THERE WAS NO KNOWN RESISTANCE DURING ADVANCEMENT OR WITHDRAW OF THE DELIVERY CATHETER. THERE WAS NO HARM TO THE PATIENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12274924 ↗