GORE EXCLUDER Conf AAA Endo - Aortic Extender CXA260005Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00733132650941), received between Nov 11, 2021 and May 19, 2026 — classified as 1 death, 12 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Malposition of Device” (3 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• InjuryMay 19, 2026Migration

  ON (B)(6) 2026, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS. ON (B)(6) 2026, FOLLOW-UP COMPUTED TOMOGRAPHY IMAGING REVEALED THAT THE RIGHT RENAL ARTERY WAS COVERED BY THE AORTIC EXTENDER COMPONENT. A REINTERVENTION WAS PERFORMED. A BARE STENT WAS PLACED AT THE ORIGIN OF THE RIGHT RENAL ARTERY, AND THROMBECTOMY WAS PERFORMED. A STENT GRAFT WAS PLACED TO COVER RESIDUAL THROMBUS IN THE RIGHT RENAL ARTERY. AFTER CONFIRMING BLOOD FLOW IN THE RIGHT RENAL ARTERY, THE PROCEDURE WAS COMPLETED. THE PATIENT TOLERATED THE PROCEDURE WELL. THE PHYSICIAN REPORTED THAT, DURING THE INITIAL PROCEDURE, THE AORTIC EXTENDER COMPONENT MAY HAVE MIGRATED PROXIMALLY WHEN BALLOONING WAS UNINTENTIONALLY PERFORMED BETWEEN THE TRUNK-IPSILATERAL LEG COMPONENT AND THE AORTIC EXTENDER COMPONENT. ALTERNATIVELY, ALTHOUGH BLOOD FLOW IN THE RIGHT RENAL ARTERY WAS CONFIRMED DURING THE FINAL ANGIOGRAPHY WITH THE GUIDEWIRE STILL IN PLACE, IT IS POSSIBLE THAT, AFTER REMOVAL OF THE GUIDEWIRE, THE AORTIC EXTENDER COMPONENT MIGRATED DUE TO SOME FACTOR AND CONSEQUENTLY COVERED THE RIGHT RENAL ARTERY.

  Patient problems: Obstruction/Occlusion; Thrombosis/Thrombus

  MAUDE report 25211973 ↗
• InjuryNov 13, 2025Off-Label Use; Migration; Device Endoleak; Off-Label Use; Migration; Device Endoleak

  ON (B)(6) 2025, THE PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE TO TREAT A 10 CM SYMPTOMATIC ABDOMINAL ANEURYSM UTILIZING GORE® EXCLUDER® AAA ENDOPROSTHESES (PLC231200 AND PLC231000) AND A GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS (CXA260005). THE PLC231200 WAS IMPLANTED IN THE LEFT COMMON ILIAC ARTERY, THEN EXTENDED WITH THE PLC231000 FOR ADDITIONAL COVERAGE, AND THEN THE CXA260005 WAS IMPLANTED DISTAL TO THE PLC231000 AS ADDITIONAL COVERAGE. IN ADDITION TO THESE THREE DEVICES IN THE LEFT COMMON ILIAC ARTERY, THE PATIENT WAS IMPLANTED WITH A GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS (CXT) AND TWO OTHER GORE® EXCLUDER® AAA ENDOPROSTHESES (CONTRALATERAL LEGS) IN THE RIGHT COMMON ILIAC ARTERY. ON THE FINAL ANGIOGRAM FOR THE INITIAL PROCEDURE, THERE WAS A TYPE 2 ENDOLEAK REPORTED WHICH THE PHYSICIAN PLANNED TO MONITOR. THIS TYPE 2 ENDOLEAK WAS CAUSED BY COLLATERALIZATION FEEDING THE ANEURYSM SAC. IT IS UNKNOWN IF THERE WAS ANEURYSM ENLARGEMENT ASSOCIATED WITH THIS TYPE 2 ENDOLEAK. ON (B)(6) 2025, THE PATIENT UNDERWENT A REINTERVENTION AS THE PLC231200, PLC231000, AND CXA260005 HAD MIGRATED PROXIMALLY AS ONE UNIT INTO THE LEFT COMMON ILIAC ARTERY, CAUSING A TYPE 1B ENDOLEAK.

  Patient problems: Clinical Endoleak; Hemorrhage/Blood Loss/Bleeding; Ruptured Aneurysm

  MAUDE report 23547213 ↗
• InjuryJul 23, 2025Device-Device Incompatibility; Device-Device Incompatibility

  ON (B)(6) 2025 THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF A ZONE 9 ABDOMINAL AORTIC ANEURYSM AND WAS IMPLANTED WITH TWO GORE® EXCLUDER® CONFORMABLE AORTIC EXTENDERS COMPONENTS AND ONE GORE® EXCLUDER® AORTIC EXTENDERS COMPONENT. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2025, THE PATIENT UNDERWENT REINTERVENTION FOR A SUSPECTED TYPE II OR TYPE III ENDOLEAK BETWEEN THE FIRST (MOST DISTAL CXA260005) AND SECOND (MIDDLE PLA260300) AORTIC EXTENDER COMPONENTS. AN ADDITIONAL GORE® EXCLUDER® CONFORMABLE AORTIC EXTENDERS COMPONENT WAS IMPLANTED TO RELINE THE SEAL OF THE TWO DEVICES. THERE WAS NO ANEURYSM ENLARGEMENT REPORTED AND THE TYPE ENDOLEAK WAS UNABLE TO BE DETERMINED. THE PATIENT TOLERATED THE PROCEDURE AND THE ENDOLEAK WAS RESOLVED.

  Patient problems: Clinical Endoleak

  MAUDE report 22579973 ↗
• InjuryMar 3, 2025Malposition of Device; Malposition of Device

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2025, A PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF A PROXIMAL TYPE I ENDOLEAK AFTER NON-GORE DEVICE IMPLANTATION, AORFIX, USING GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS. DURING THE TREATMENT, SECOND AORTIC EXTENDER UNINTENTIONALLY COVERED THE LEFT RENAL ARTERY. FOR TREAT, ADDITIONAL STENT, EXPRESS 6 MM, WAS IMPLANTED INTO THE LEFT RENAL ARTERY. THE PATIENT TOLERATED THE PROCEDURE. THE PHYSICIAN STATED THAT THE AORTIC EXTENDER WAS MOVED PROXIMALLY MORE THAN EXPECTED.

  Patient problems: Obstruction/Occlusion

  MAUDE report 21510693 ↗
• MalfunctionAug 5, 2024Activation Failure; Activation Failure

  ON (B)(6) 2024, THIS PATIENT UNDERWENT AN ENDOVASCULAR TREATMENT FOR AN INFRARENAL SACCULAR ANEURYSM USING GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS WITH ACTIVE CONTROL SYSTEM. WHEN THE PHYSICIAN INITIATED THE DEPLOYMENT OF AN AORTIC EXTENDER ENDOPROSTHESIS (CXA260005) JUST BELOW THE LOWER RENAL ARTERY, THE DISTAL STENT ROW EXPANDED AND POSITIONED HORIZONTALLY AGAINST THE RIGHT SIDE OF THE AORTA, WHICH DID NOT RESOLVE EVEN AFTER OPENING THE REST OF THE STENT ROWS. UPON COMPLETION OF THE DEPLOYMENT, THE DISTAL END OF THE STENT GRAFT LOOKED INFOLDED. ANOTHER AORTIC EXTENDER ENDOPROSTHESIS OF THE SAME SIZE WAS ADDED DISTALLY, HOWEVER, THE SAME EXACT EVENT WAS OBSERVED DURING THE DEPLOYMENT. THE PHYSICIAN PERFORMED A BALLOONING WITHIN TWO AORTIC EXTENDER ENDOPROSTHESIS WHICH RESTORED THE SHAPE OF DEVICES TO AN ACCEPTABLE EXTENT, HOWEVER, THE DISTAL END OF BOTH DEVICES LOOKED TO HAVE SHORTENED DUE TO THE DISTAL STENT ROW BEING NESTED. NO ENDOLEAKS WERE PERFORMED AT THE END OF THE PROCEDURE, THEREFORE, NO ADDITIONAL TREATMENT WAS REQUIRED. THE PATIENT TOLERATED THE PROCEDURE. IT IS UNKNOWN WHICH AORTIC EXTENDER ENDOPROSTHESIS WAS IMPLANTED PROXIMALLY/DISTALLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19905752 ↗
• MalfunctionAug 4, 2024Activation Failure; Activation Failure

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2024, THIS PATIENT UNDERWENT AN ENDOVASCULAR TREATMENT FOR AN INFRARENAL SACCULAR ANEURYSM USING GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS WITH ACTIVE CONTROL SYSTEM. WHEN THE PHYSICIAN INITIATED THE DEPLOYMENT OF AN AORTIC EXTENDER ENDOPROSTHESIS (CXA260005) JUST BELOW THE LOWER RENAL ARTERY, THE DISTAL STENT ROW EXPANDED AND POSITIONED HORIZONTALLY AGAINST THE RIGHT SIDE OF THE AORTA, WHICH DID NOT RESOLVE EVEN AFTER OPENING THE REST OF THE STENT ROWS. UPON COMPLETION OF THE DEPLOYMENT, THE DISTAL END OF THE STENT GRAFT LOOKED INFOLDED. ANOTHER AORTIC EXTENDER ENDOPROSTHESIS OF THE SAME SIZE WAS ADDED DISTALLY, HOWEVER, THE SAME EXACT EVENT WAS OBSERVED DURING THE DEPLOYMENT. THE PHYSICIAN PERFORMED A BALLOONING WITHIN TWO AORTIC EXTENDER ENDOPROSTHESIS WHICH RESTORED THE SHAPE OF DEVICES TO AN ACCEPTABLE EXTENT, HOWEVER, THE DISTAL END OF BOTH DEVICES LOOKED TO HAVE SHORTENED DUE TO THE DISTAL STENT ROW BEING NESTED. NO ENDOLEAKS WERE PERFORMED AT THE END OF THE PROCEDURE, THEREFORE, NO ADDITIONAL TREATMENT WAS REQUIRED. THE PATIENT TOLERATED THE PROCEDURE. IT IS UNKNOWN WHICH AORTIC EXTENDER ENDOPROSTHESIS WAS IMPLA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19903451 ↗
• InjuryMay 22, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  THE GORE FIELD SALES ASSOCIATE (FSA) REPORTED THE FOLLOWING: ON (B)(6) 2024, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESES. REPORTEDLY AFTER STAGE ONE DEPLOYMENT OF THE CONFORMABLE TRUNK-IPSILATERAL LEG ENDOPROSTHESIS, THE GRAFT DID NOT OPEN ALL THE WAY. IT APPEARED SOMETHING WAS STILL ATTACHED TO THE GRAFT AND EVERY TIME THE DELIVERY CATHETER WAS MOVED, THE TOP OF WHAT APPEARED TO BE ATTACHED, MOVED DISTALLY ALSO. UPON FINAL DEPLOYMENT OF THE CONFORMABLE TRUNK-IPSILATERAL LEG ENDOPROSTHESIS THE GRAFT MIGRATED DISTALLY (AMOUNT IS UNKNOWN) DURING THE DEPLOYMENT. A PROXIMAL TYPE I ENDOLEAK WAS OBSERVED. A CONFORMABLE AORTIC EXTENDER WAS ENDOPROSTHESIS WAS IMPLANTED AT PROXIMAL END OF CONFORMABLE TRUNK-IPSILATERAL LEG ENDOPROSTHESIS, AND THIS PARTIALLY COVERED THE LEFT RENAL ARTERY. THE RENAL ARTERY WAS STENTED. THE ENDOLEAK WAS RESOLVED. THE PATIENT TOLERATED THE PROCEDURE. REPORTEDLY THE PATIENT HAD TORTUOUS ANATOMY AND THE AORTIC NECK WAS ANGLED AT 60-70 DEGREES. THERE WAS NO CALCIUM OR THROMBUS PRESENT IN THE AORTIC NECK. A AMPLATZ SUPER STIFF¿ GUIDEWIRE WAS BEING USED FOR THE PROCEDURE. THE ROOT C

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

  MAUDE report 19378356 ↗
• InjuryDec 6, 2023Malposition of Device; Migration; Malposition of Device; Migration

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2023, THIS PATIENT UNDERWENT AN ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESES, GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESES AND GORE® DRYSEAL FLEX INTRODUCER SHEATHS AS ACCESSORIES. THE CONTRALATERAL LEG ENDOPROSTHESIS WAS DEPLOYED IN THE PATIENTS RIGHT SIDE/CONTRALATERAL SIDE. THE LEG COULD NOT BE PUSHED UP ENOUGH TO THE TARGET SITE AND UNINTENTIONALLY COVERED THE BIFURCATION OF THE RIGHT INTERNAL ILIAC ARTERY, RESULTING IN REDUCED BLOOD FLOW TO THE RIGHT INTERNAL ILIAC ARTERY. ALTHOUGH PUSHING UP THE LEG BY USING THE EDGE OF THE 12 FR SHEATH IMPROVED BLOOD FLOW, A DISSECTION OCCURRED BY THE SHEATH EDGE AND BLOOD FLOW INTO THE FALSE LUMEN OF THE RIGHT COMMON ILIAC ARTERY WAS OBSERVED. AS A TREATMENT, AN ADDITIONAL BARE STENT WAS IMPLANTED IN THE RIGHT EXTERNAL ILIAC ARTERY AND BLOOD FLOW TO THE FALSE LUMEN DISAPPEARED. AN ANGIOGRAPHY CONFIRMED DELAYED BLOOD FLOW INTO THE RIGHT INTERNAL ILIAC ARTERY. WHEN AN AORTIC EXTENDER WAS DEPLOYED IN THE PROXIMAL SIDE, IT MOVED PROXIMALLY AND COVERED HALFWAY OF THE RENAL ARTERY. THE PATIENT TOLERATED THE PROCEDURE AND WAS DECIDED TO

  Patient problems: Obstruction/Occlusion; Reduced Blood Flow

  MAUDE report 18273859 ↗
• DeathOct 11, 2023Malposition of Device; Malposition of Device

  ON AN UNKNOWN DATE APPROXIMATELY 20 YEARS AGO THIS PATIENT UNDERWENT AN OPEN AORTIC BIFURCATED REPAIR OF THE ABDOMINAL AORTA. ON (B)(6) 2023, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR A LEAK (UNKNOWN TYPE) AT THE ANASTOMOSIS SITE. THE TREATMENT PLAN WAS TO PLACE 2 GORE® EXCLUDER® AORTIC EXTENDER ENDOPROSTHESIS (CXA23005 X2) (AE'S) ACROSS THE ANASTOMOSIS AND ACHIEVE SEAL. THE FIRST AE WAS DEPLOYED AT THE LEVEL OF THE BIFURCATION WITH THE SECOND AE DEPLOYED AT THE LEVEL OF THE RENAL ARTERY WITH SIGNIFICANT OVERLAP OF THE AE'S. BOTH GORE® EXCLUDER® AORTIC EXTENDER ENDOPROSTHESES DEPLOYED PROPERLY AND SUCCESSFULLY. WHEN BALLOONING WITH A GORE® MOLDING & OCCLUSION BALLOON CATHETER (MOB); WE BALLOONED THE OVERLAP ZONE AND AT THE LEVEL OF THE RENAL ARTERIES, AND A LITTLE OUTSIDE THE GRAFT PROXIMALLY. THE PATIENT THEN EXPERIENCED A SUDDEN DROP IN BLOOD PRESSURE. SUBSEQUENTLY AN AORTIC RUPTURE WAS IDENTIFIED (WHICH APPEARED TO BE A TEAR LONGITUDINALLY) JUST OUTSIDE THE PROXIMAL AE. THE MOB WAS RELOCATED ABOVE THE LEVEL OF THE RENAL ARTERIES IN AN ATTEMPT TO GET SOME STABILITY OF THE BLOOD FLOW AND THE PATIENT. TWO ADDITIONAL GORE® EXCLUDER® AORTIC EXTENDER COMPONENTS (CXA23005 AND C

  Patient problems: Clinical Endoleak

  MAUDE report 17917116 ↗
• InjuryJun 27, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  ON (B)(6) 2023, THIS PATIENT UNDERWENT AN ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS WITH ACTIVE CONTROL SYSTEM AND GORE® EXCLUDER® AAA ENDOPROSTHESIS. REPORTEDLY, THE PATIENTS¿ AORTIC NECK WAS SEVERELY ANGULATED AS 100-DEGREE. THE NECK LENGTH WAS 32 MM, MOST OF WHICH WAS RUNNING HORIZONTALLY. AFTER COIL EMBOLIZING BOTH INTERNAL ILIAC ARTERIES, A TRUNK - IPSILATERAL LEG ENDOPROSTHESIS WAS DELIVERED FROM THE RIGHT SIDE. THE PHYSICIAN SET THE PROXIMAL END OF THE DEVICE ABOUT 1 CM BELOW THE RIGHT RENAL ARTERY AND INITIATED THE DEPLOYMENT. AS THE PROXIMAL STENT ROW WAS BEING DEPLOYED, THE DEVICE MOVED DISTALLY TOWARDS THE GREATER CURVATURE OF AORTA. THE PHYSICIAN ATTEMPTED TO REPOSITION THE DEVICE BY TURNING THE CONSTRAINING DIAL AND ADVANCING THE ANGULATION WIRE, HOWEVER, THE PROXIMAL ANCHORS WERE NOT FULLY CONSTRAINED. IT SEEMED ONLY THE DISTAL END OF THE ANCHOR SEAL ROW WAS CONSTRAINED. THE PHYSICIAN RETRACTED THE ANGULATION WIRE AND TRIED TO ADVANCE THE DELIVERY CATHETER PROXIMALLY TO REPOSITION THE PROXIMAL TRUNK, HOWEVER, THE PROXIMAL ANCHORS SEEMED TO HAVE BEEN CAUGHT ON VESSEL WALL AND THEREFORE THE DEVICE REFUSE

  Patient problems: Clinical Endoleak

  MAUDE report 17213817 ↗
• InjuryJun 27, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  ON (B)(6) 2023, THIS PATIENT UNDERWENT AN ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS WITH ACTIVE CONTROL SYSTEM AND GORE® EXCLUDER® AAA ENDOPROSTHESIS. REPORTEDLY, THE PATIENTS¿ AORTIC NECK WAS SEVERELY ANGULATED AS 100-DEGREE. THE NECK LENGTH WAS 32 MM, MOST OF WHICH WAS RUNNING HORIZONTALLY. AFTER COIL EMBOLIZING BOTH INTERNAL ILIAC ARTERIES, A TRUNK - IPSILATERAL LEG ENDOPROSTHESIS WAS DELIVERED FROM THE RIGHT SIDE. THE PHYSICIAN SET THE PROXIMAL END OF THE DEVICE ABOUT 1 CM BELOW THE RIGHT RENAL ARTERY AND INITIATED THE DEPLOYMENT. AS THE PROXIMAL STENT ROW WAS BEING DEPLOYED, THE DEVICE MOVED DISTALLY TOWARDS THE GREATER CURVATURE OF AORTA. THE PHYSICIAN ATTEMPTED TO REPOSITION THE DEVICE BY TURNING THE CONSTRAINING DIAL AND ADVANCING THE ANGULATION WIRE, HOWEVER, THE PROXIMAL ANCHORS WERE NOT FULLY CONSTRAINED. IT SEEMED ONLY THE DISTAL END OF THE ANCHOR SEAL ROW WAS CONSTRAINED. THE PHYSICIAN RETRACTED THE ANGULATION WIRE AND TRIED TO ADVANCE THE DELIVERY CATHETER PROXIMALLY TO REPOSITION THE PROXIMAL TRUNK, HOWEVER, THE PROXIMAL ANCHORS SEEMED TO HAVE BEEN CAUGHT ON VESSEL WALL AND THEREFORE THE DEVICE REFUSE

  Patient problems: Clinical Endoleak

  MAUDE report 17213684 ↗
• InjuryJun 12, 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 WAS TREATED FOR A PENETRATING ULCER OF THE INFRARENAL AORTA USING TWO GORE® EXCLUDER® CONFORMABLE AAA AORTIC EXTENDER ENDOPROSTHESIS. ¿IT IS NOTABLE THAT THE PATIENT WAS KNOWN TO BE SEPTIC AT THE TIME OF THE ORIGINAL IMPLANT¿. IT WAS REPORTED THAT ON (B)(6) 2023, THE PATIENT PRESENTED TO THE HOSPITAL WITH A DIAGNOSIS OF AORTITIS AND A CONCERNING AREA THAT HAD DEVELOPED NEAR THE AORTIC BIFURCATION AND DISTAL TO THE TWO GORE® EXCLUDER® CONFORMABLE AAA AORTIC EXTENDER ENDOPROSTHESES IN THE INFRARENAL AORTA. THE PHYSICIAN DECIDED TO TREAT THE AREA TO PREVENT ANY CHANCE OF AORTIC RUPTURE, EVEN IN THE PRESENCE OF AORTITIS. THE FOLLOWING DEVICES WERE USED TO TREAT THIS DISEASED AREA: (CEB231210A L/S#: (B)(6); PLL161207 L/S#: (B)(6); PLC121000 L/S#: (B)(6)). THE PATIENT WAS TREATED SUCCESSFULLY AND TOLERATED THE PROCEDURE WELL.

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

  MAUDE report 17114033 ↗
• InjuryJun 12, 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 WAS TREATED FOR A PENETRATING ULCER OF THE INFRARENAL AORTA USING TWO GORE® EXCLUDER® CONFORMABLE AAA AORTIC EXTENDER ENDOPROSTHESIS. ¿IT IS NOTABLE THAT THE PATIENT WAS KNOWN TO BE SEPTIC AT THE TIME OF THE ORIGINAL IMPLANT¿. IT WAS REPORTED THAT ON (B)(6) 2023, THE PATIENT PRESENTED TO THE HOSPITAL WITH A DIAGNOSIS OF AORTITIS AND A CONCERNING AREA THAT HAD DEVELOPED NEAR THE AORTIC BIFURCATION AND DISTAL TO THE TWO GORE® EXCLUDER® CONFORMABLE AAA AORTIC EXTENDER ENDOPROSTHESES IN THE INFRARENAL AORTA. THE PHYSICIAN DECIDED TO TREAT THE AREA TO PREVENT ANY CHANCE OF AORTIC RUPTURE, EVEN IN THE PRESENCE OF AORTITIS. THE FOLLOWING DEVICES WERE USED TO TREAT THIS DISEASED AREA: (CEB231210A L/S#: 26365662; PLL161207 L/S#: 26464956; PLC121000 L/S#: 26537814). THE PATIENT WAS TREATED SUCCESSFULLY AND TOLERATED THE PROCEDURE WELL.

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

  MAUDE report 17113681 ↗
• InjuryJun 21, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  ON AN UNKNOWN DATE, THIS PATIENT WAS TREATED FOR AN ABDOMINAL AORTIC ANEURYSM WITH A MEDTRONIC ENDURANT DEVICE. IT WAS REPORTED THE PATIENT PRESENTED AT ATRIUM WAKE FOREST BAPTIST HEALTH AND THAT IMAGES (DATE AND MODALITY IS UNKNOWN) REVEALED A PROXIMAL TYPE I ENDOLEAK. THE PHYSICIAN CHOSE TO TREAT THE ENDOLEAK ON (B)(6) 2022, WITH TWO GORE® AORTIC EXTENDER ENDOPROSTHESES. THE FIELD SALES ASSOCIATE REPORTED THE FOLLOWING ¿THE PHYSICIAN DECIDED TO PLACE A 26MM CONFORMABLE CUFF (GORE® AORTIC EXTENDER ENDOPROSTHESIS) AT THE RENAL ARTERIES AND 28MM CONFORMABLE CUFF (GORE® AORTIC EXTENDER ENDOPROSTHESIS) OUT OF THE 26 AND INTO THE 28MM MEDTRONIC GRAFT. A 16FR SHEATH (16FR GORE® DRYSEAL FLEX INTRODUCER SHEATH LOT/SERIAL NUMBER IS UNK) WAS INSERTED. THE 26MM CUFF WAS ADVANCED THROUGH THE 16FR SHEATH WITHOUT INCIDENT, THE PHYSICIAN REMOVED THE CUFF (GORE® AORTIC EXTENDER ENDOPROSTHESIS) THROUGH THE SHEATH AND PLACED A PIGTAIL CATHETER IN TO TAKE ANOTHER ANGIO TO MARK THE RENAL ARTERY. THE 26MM CUFF (GORE® AORTIC EXTENDER ENDOPROSTHESIS) WAS RE-ADVANCED INTO POSITION, THE ANGULATION WIRE WAS DEPLOYED COMPLETELY, THE CUFF (GORE® AORTIC EXTENDER ENDOPROSTHESIS) WAS DEPLOYED IN POSITION, THE A

  Patient problems: Aneurysm

  MAUDE report 14753984 ↗
• InjuryNov 11, 2021Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  ON (B)(6) 2021, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR ABDOMINAL AORTIC ANEURYSM AND WAS IMPLANTED WITH GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS. INTRAPROCEDURE IMAGING SHOWED A SLIGHT TYPE I ENDOLEAK AND A GORE® EXCLUDER® CONFORMABLE AORTIC EXTENDER COMPONENT WAS PLACED TO EXTEND COVERAGE. CONCLUSION ANGIOGRAPHY SHOWED AN UNKNOWN ARTIFACT ABOVE THE RENAL ARTERIES. THE ENDOLEAK WAS RESOLVED AND THE PROCEDURE WAS CONCLUDED. THE PATIENT WAS TRANSFERRED TO ANOTHER HOSPITAL WHEREIN THEY REINTEVENED AND PLACED STENTS IN THE SUPERIOR MESENTERIC ARTERY AND THE LEFT RENAL ARTERY. THEY WERE NOT ABLE TO STENT THE RIGHT RENAL ARTERY. THE PATIENT TOLERATED THE PROCEDURE AND IS DUE TO BE DISCHARGED TOMORROW.

  Patient problems: Aneurysm

  MAUDE report 12797586 ↗