GORE EXCLUDER Conf AAA Endo - Aortic Extender CXA200005Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00733132650927), received between Oct 2, 2023 and Mar 18, 2026 — classified as 1 death, 7 injuries, 1 malfunction.

The most frequently reported specific device problem is “Malposition of Device” (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 18, 2026Device Endoleak

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2025, A PATIENT WAS TREATED USING A GORE® EXCLUDER® CONFORMABLE AAA. ENDOPROSTHESIS. ON (B)(6) 2025, THE PATIENT HAD A REINTERVENTION FOR A TYPE II ENDOLEAK. THE PHYSICIAN USED A LASER TO CROSS THROUGH THE GRAFT, COILED THE ANEURYSM SAC, AND COVERED HOLE WITH A 20 MM CUFF.

  Patient problems: Clinical Endoleak

  MAUDE report 24626865 ↗
• InjuryFeb 24, 2026Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2025, THIS PATIENT UNDERWENT AN ENDOVASCULAR TREATMENT FOR RIGHT SUBCLAVIAN ARTERY ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESIS AND GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS. FOLLOWING CONSTRUCTION OF RIGHT SUBCLAVIAN-COMMON CAROTID ARTERY BYPASS WITH GORE® PROPATEN® VASCULAR GRAFT, AN ILIAC EXTENDER AND AN AORTIC EXTENDER WERE IMPLANTED FROM THE RIGHT COMMON CAROTID ARTERY TO THE BRACHIOCEPHALIC ARTERY. THE ORIGIN OF THE RIGHT SUBCLAVIAN ARTERY WAS EMBOLIZED. THE PATIENT TOLERATED THE PROCEDURE. THEREAFTER, THE PATIENT WAS ADMITTED TO ANOTHER HOSPITAL FOR ANOTHER DISEASE AND A CT SCAN SHOWED NEW ANEURYSM DEVELOPMENT ON THE BRACHIOCEPHALIC ARTERY, AND ON (B)(6) 2026, THE PATIENT WAS TRANSFERRED TO THE REPORTING HOSPITAL. AN ADDITIONAL PROCEDURE WAS SCHEDULED. ON (B)(6) 2026, A REINTERVENTION WAS PERFORMED FOR SUSPECTED MYCOTIC BRACHIOCEPHALIC ARTERY ANEURYSM. ZONE 0 TEVAR WITH TOTAL DEBRANCHING WAS PERFORMED USING GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM. THE PREVIOUSLY IMPLANTED ILIAC EXTENDER AND AORTIC EXTENDER WERE EXPLANTED. THE PATIENT TOLERATED THE PROCEDURE. THE REPORTING PHYSI

  Patient problems: Aneurysm; Unspecified Infection

  MAUDE report 24425144 ↗
• InjuryJan 29, 2026Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2026, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESIS. ON THE FINAL ANGIOGRAPHY, A DISSECTION WAS OBSERVED NEAR THE SUPERIOR MESENTERIC ARTERY, PROXIMAL TO THE AORTIC EXTENDER COMPONENT. SINCE IT WAS A LOCALIZED DISSECTION, NO FURTHER TREATMENT WAS PERFORMED. THE PATIENT TOLERATED THE PROCEDURE. IT WAS REPORTED THAT THE DISSECTION WAS NOT OBSERVED ON THE ANGIOGRAPHY THAT WAS PERFORMED PRIOR TO PLACE AORTIC EXTENDER COMPONENT.

  Patient problems: Vascular Dissection

  MAUDE report 24206769 ↗
• InjuryDec 8, 2025Malposition of Device; Malposition of Device

  ON (B)(6) 2025, THE PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE TO TREAT A PENETRATING AORTIC ULCER (PAU) UTILIZING A GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS (CXA200005). REPORTEDLY, THE PAU WAS 6 MM DISTAL TO THE LEFT RENAL ARTERY AND THE DEVICE WAS INTENTIONALLY PLACED ABOUT 2 MM INTO THE LEFT RENAL ARTERY ORIGIN AND DEPLOYED. A POST-DEPLOYMENT AORTOGRAM SHOWED THE DEVICE WAS UNINTENTIONALLY COVERING MOST OF THE LEFT RENAL ARTERY, ABOUT 6-7 MM INTO THE LEFT RENAL ARTERY ORIGIN. REPORTEDLY, THE PHYSICIAN ATTEMPTED TO PULL THE DEVICE DOWN WITH A BALLOON AND ATTEMPTED TO WIRE THE LEFT RENAL ARTERY ORIGIN, HOWEVER, ALL ATTEMPTS WERE UNSUCCESSFUL. THE INITIAL POST-DEPLOYMENT PHOTOS SHOWED BLOOD FLOW INTO THE LEFT RENAL ARTERY, BUT AS THE PHYSICIAN ATTEMPTED TO PLACE A GUIDEWIRE INTO THE VESSEL, IT OCCLUDED AT SOME POINT WHICH CAUSED AN IMPAIRMENT TO BLOOD FLOW. AT THIS POINT, THE PHYSICIAN ELECTED TO CONVERT THE PROCEDURE TO AN OPEN REPAIR AND MADE A SURGICAL BYPASS FROM THE AORTA TO THE LEFT RENAL ARTERY, RE-ESTABLISHING FLOW TO THE LEFT RENAL ARTERY. THE CXA200005 REMAINS IMPLANTED. THE PHYSICIAN BELIEVES THE CAUSE OF THE EVENT WAS STARTING THE DEPLOYMENT OF THE CXA200005 TOO

  Patient problems: Obstruction/Occlusion

  MAUDE report 23750710 ↗
• MalfunctionMar 21, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  ON (B)(6) 2025, WHEN PREPPING AN GORE® EXCLUDER® CONFORMABLE AAA AORTIC EXTENDER ENDOPROSTHESIS, IT WAS REPORTED THAT THE PHYSICIAN ENCOUNTERED EXTREME DIFFICULTY REMOVING THE PACKAGING MANDREL/STYLET FROM THE LEADING OLIVE OF THE DEVICE. AFTER SUCCESSFULLY REMOVING THE MANDREL WITH HEMOSTATS THE DELIVERY SYSTEM WAS FLUSHED AND SUCCESSFULLY DEPLOYED AND IMPLANTED. WHEN REMOVING THE DELIVERY SYSTEM FROM A 15FR GORE® DRYSEAL FLEX INTRODUCER SHEATH TIP BROKE OFF.

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

  MAUDE report 21666030 ↗
• DeathDec 30, 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) 2024, FOUR GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICE), TWO GORE® EXCLUDER® AAA ENDOPROSTHESIS AND THREE GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS WERE IMPLANTED DURING A COVERED ENDOVASCULAR RECONSTRUCTION OF THE AORTIC BIFURCATION (CERAB) PROCEDURE DURING TREATMENT OF OCCLUSIVE DISEASE. IT WAS REPORTED THAT A 20MM X 4.5CM AORTIC CUFF WAS IMPLANTED IN THE DISTAL AORTA, THEN A 23MM X 4.5CM CUFF WAS PLACED AS A BUILDUP DEVICE. AN 11MM X 79MM VBX DEVICE WAS PLACED IN THE RIGHT ILIAC ARTERY AND AN 11MM X 59MM PLACED IN THE LEFT ILIAC ARTERY AND AN 11MM X 59MM VBX DEVICE WAS PLACED INTO THE LEFT HYPOGASTRIC ARTERY. DURING THE REMOVAL OF THE LEFT VBX DELIVERY CATHETER, THE BALLOON HAD GOT CAUGHT ON THE INTRODUCER SHEATH (MANUFACTURER UNKNOWN) AND THE DELIVERY CATHETER BROKE APPROXIMATELY 10CM FROM THE HUB. THE RIGHT AND LEFT ILIAC ARTERY VBX DEVICES WERE BALLOONED WITH A 12MM AND THEN A 14MM ATLAS¿ GOLD PTA DILATATION CATHETER. IT WAS THEN REALIZED THAT THE DISTAL AORTA RUPTURED ON THE DISTAL SIDE OF THE 20MM AORTIC CUFF. THE PHYSICIAN THEN ATTEMPTED TO BALLOON THE DISTAL AORTIC CUFFS WITH A 16MM ATLAS¿

  Patient problems: Rupture

  MAUDE report 21037215 ↗
• InjuryAug 22, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  ON (B)(6) 2022, THE PATIENT UNDERWENT AN ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESES AND GORE® EXCLUDER®AAA ENDOPROSTHESES. ANGIOGRAPHY AFTER STENTGRAFTS PLACEMENT CONFIRMED A PROXIMAL TYPE I ENDOLEAK AT THE OUTER CURVATURE OF THE AORTA. THE PROCEDURE WAS COMPLETED, AND THE PATIENT WAS DECIDED TO BE MONITORED. ON AN UNKNOWN DATE, IT WAS OBSERVED THAT THE PROXIMAL TYPE I ENDOLEAK STILL REMAINED AT THE POSTOPERATIVE FOLLOW-UP EXAMINATION. THE DECISION WAS MADE TO PERFORM ADDITIONAL INTERVENTION. IT IS UNKNOWN IF THE ANEURYSM HAD ENLARGED OR NOT. ON (B)(6) 2024, A REINTERVENTION WAS PERFORMED. A CHIMNEY STENTGRAFT WAS PLACED IN EACH OF THE LEFT AND RIGHT RENAL ARTERIES, AND AN ADDITIONAL STENT GRAFT (ENDURANT CUFF 32MM X 49MM) WAS IMPLANTED TO THE MOST PROXIMAL SIDE. THE ENDOLEAK WAS RESOLVED, AND THE PROCEDURE WAS COMPLETED.

  Patient problems: Clinical Endoleak

  MAUDE report 20044358 ↗
• InjuryMar 4, 2024Malposition of Device; Malposition of Device

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2024, THIS PATIENT UNDERWENT AN ENDOVASCULAR TREATMENT FOR ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS AND GORE® EXCLUDER® AAA ENDOPROSTHESIS. DURING THE PROCEDURE, AORTIC EXTENDER ENDOPROSTHESIS WAS DEPLOYED AT THE POSITION TO COVER THE LEFT RENAL ARTERY PARTIALLY TO REINFORCE THE PROXIMAL SEALING. AT THAT TIME, THE ENDOPROSTHESIS WAS DEPLOYED MORE PROXIMALLY THAN EXPECTED, AND DELAY OF BLOOD FLOW TO THE LEFT RENAL ARTERY WAS OBSERVED. ADDITIONAL STENT WAS DEPLOYED IN THE LEFT RENAL ARTERY, AND BLOOD FLOW IMPROVED. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Obstruction/Occlusion

  MAUDE report 18823742 ↗
• InjuryOct 2, 2023Migration; Migration

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6), 2023, THIS PATIENT UNDERWENT AN ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® CONFORMABLE AORTIC EXTENDER ENDOPROSTHESIS. THREE AORTIC EXTENDERS WERE REPORTEDLY DEPLOYED. AFTER DEPLOYMENT, THE MOST PROXIMAL DEVICE MIGRATED APPROXIMATELY 2~3MM PROXIMALLY RESULTING IN UNINTENTIONAL COVERAGE OF THE RIGHT RENAL ARTERY. A BARE STENT WAS PLACED IN THE RIGHT RENAL ARTERY. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Obstruction/Occlusion

  MAUDE report 17852868 ↗