GORE EXCLUDER Conf AAA Endo - Aortic Extender CXA360005Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 00733132650972), received between Mar 1, 2023 and Jul 16, 2026 — classified as 2 deaths, 17 injuries, 4 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 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• DeathJul 16, 2026Adverse Event Without Identified Device or Use Problem

  ON (B)(6), 2026, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM USING THE GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS AND THE GORE® EXCLUDER® AAA ENDOPROSTHESIS, AND THE GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX) DEVICES WERE PLACED IN THE BILATERAL RENAL ARTERIES USING THE CHIMNEY TECHNIQUE. THE GORE® DRYSEAL FLEX INTRODUCER SHEATH WAS USED FOR ACCESS, AND THE GORE® MOLDING & OCCLUSION BALLOON CATHETER WAS USED FOR TOUCH-UP. AFTER ALL DEVICES WERE PLACED, DIGITAL SUBTRACTION ANGIOGRAPHY(DSA) REVEALED SLOW FLOW IN THE BILATERAL RENAL ARTERIES, AND THE RIGHT SIDE VBX DEVICE WAS SLIGHTLY KINKED. A TYPE II ENDOLEAK WAS ALSO OBSERVED IN THE RIGHT RENAL ARTERY; THEREFORE, AN ADDITIONAL STENT GRAFT WAS PLACED PROXIMALLY. THE SLOW FLOW WAS SLIGHTLY IMPROVED, AND THE PHYSICIAN ELECTED TO MONITOR IT. THE PROCEDURE WAS COMPLETED WITHOUT FURTHER ISSUES. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6), 2026, THE PATIENT DEVELOPED MULTIPLE CEREBRAL INFARCTIONS AND EXPIRED. IT WAS REPORTED THAT THE PATIENT HAD A SIGNIFICANT SHAGGY AORTA.

  Patient problems: Ischemia Stroke

  MAUDE report 25834601 ↗
• InjuryDec 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING WAS REPORTED: IT WAS REPORTED THAT ON (B)(6) 2025, THE PATIENT WAS IMPLANTED WITH GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM TO TREAT A THORACIC ANEURYSM. IT WAS REPORTED THAT THERE WAS A PREVIOUSLY IMPLANTED ZENITH ALPHA¿ THORACIC ENDOVASCULAR GRAFT IN THE THORACIC AORTA. THERE WAS A DISTAL ANEURYSM OF THIS DEVICE AND THE PHYSICIAN CHOSE TO IMPLANT A GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM AND A GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE). THERE WAS A SMALL TYPE III ENDOLEAK ON FINAL IMAGING. THE PHYSICIAN CHOSE TO TAKE A WAIT AND WATCH APPROACH. ON (B)(6) 2025, FOLLOW UP IMAGES REVEALED THE TYPE III ANEURYSM BETWEEN THE ZENITH ALPHA DEVICE AND THE GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM HAD REMAINED. THERE IS NO ANEURYSM SAC ENLARGEMENT, AND THE PATIENT IS ASYMPTOMATIC. A REINTERVENTION WILL BE PLANNED AFTER THE NEW YEAR. EVENT IS ONGOING.

  Patient problems: Clinical Endoleak

  MAUDE report 23857685 ↗
• MalfunctionDec 3, 2025Break; Break

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2025, PATIENT UNDERWENT AN EMERGENT ENDOVASCULAR PROCEDURE TO TREAT A RUPTURED AORTIC ANEURYSM UTILIZING A GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS (CONFORMABLE AORTIC EXTENDER). REPORTEDLY, DURING THE PROCEDURE, THE CONFORMABLE AORTIC EXTENDER BROKE OFF FROM THE CATHETER UPON ATTEMPTED WITHDRAWAL INTO THE 18FR SHEATH (NON-GORE) RESULTING IN BOTH THE CONFORMABLE AORTIC EXTENDER AND THE OLIVE TIP BEING SNAPPED OFF FROM THE CATHETER IN THE COMMON ILIAC ARTERY. PHYSICIAN WANTED TO ADVANCE THE SHEATH AND WAS PLANNING TO PULL THE CONFORMABLE AORTIC EXTENDER OUT OF THE BODY, SO THAT HE COULD RE-ENGAGE THE DILATOR INTO THE SHEATH. AFTER MULTIPLE HOURS OF ATTEMPTS, WE HAD TO LEAVE BOTH THE PIECES INSIDE THE PATIENT. THE CONFORMABLE AORTIC EXTENDER WAS EXPANDED IN THE COMMON ILIAC ARTERY USING A NON-COMPLIANT BALLOON (CONQUEST) AND THE OLIVE TIP WAS ENDO TRASHED WITH ANOTHER 12MM LIMB TO TRAP IT BETWEEN TWO LIMBS. ANOTHER COMFORTABLE AORTIC EXTENDER WAS THEN USED FOR THE PROCEDURE FROM THE LEFT CONTRALATERAL SIDE AND THE FIRST 18FR SHEATH (NON-GORE) WAS REMOVED. A NEW 18FR SHEATH WAS USED BOTH ON THE RIGHT AND LEFT SIDE TO COMPLETE THE PRO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23704781 ↗
• InjuryNov 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO GORE THAT ON (B)(6) 2023, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM USING GORE EXCLUDER CONFORMABLE AAA ENDOPROSTHESES AND GORE EXCLUDER AAA ENDOPROSTHESES. A TOTAL OF FOUR STENT GRAFTS WERE IMPLANTED: ONE TRUNK IPSILATERAL LEG, ONE AORTIC EXTENDER AND TWO CONTRALATERAL LEGS. ON (B)(6) 2025, DUE TO ENLARGEMENT OF THE ANEURYSM, A REINTERVENTION WAS PERFORMED USING THE GORE TAG CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM. ONE STENT GRAFT WAS ADDITIONALLY DEPLOYED IN EACH OF THE BILATERAL RENAL ARTERIES, FOLLOWED BY DEPLOYMENT OF THE CTAG JUST DISTAL TO THE SUPERIOR MESENTERIC ARTERY. REPORTEDLY, THERE WAS BLEEDING FROM THE DELIVERY HANDLE AFTER INSERTION OF THE CTAG, AND THE PHYSICIAN HAD TO COMPLETE THE DEPLOYMENT IMMEDIATELY. NO BLOOD TRANSFUSION WAS ADMINISTERED. THE PATIENT TOLERATED THE PROCEDURE. PHYSICIAN¿S COMMENT: ¿THE DIAMETER OF THE PROXIMAL NECK EXCEEDED 32 MM, AND I WAS EXPECTING ADDITIONAL STENT GRAFT PLACEMENT IF THE ANEURYSM CONTINUES TO GROW.¿

  Patient problems: Aneurysm expansion

  MAUDE report 23652649 ↗
• InjuryJul 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2025, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF A ZONE 3 THORACIC AORTIC ANEURYSM AND WAS IMPLANTED WITH AND A GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM (CTAG-AC: TGMR404015/25932687, TGMR404020/29553071) AND A GORE® EXCLUDER® CONFORMABLE AORTIC EXTENDER ENDOPROSTHESIS (CXA360005/29553071) TO EXTEND COVERAGE PROXIMALLY. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2025, IT WAS REPORTED THAT THE PATIENT HAS A PROXIMAL TYPE I ENDOLEAK. ON (B)(6) 2025, THE PATIENT UNDERWENT REINTERVENTION AND THE PROXIMAL END WAS RELINED WITH A COOK ENDOPROSTHESIS. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Clinical Endoleak

  MAUDE report 22470178 ↗
• MalfunctionJul 3, 2025Material Integrity Problem; Material Integrity Problem

  THE FIELD SALES ASSOCIATE (FSA) REPORTED THE FOLLOWING TO GORE: ON (B)(6) 2025, THE PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE TO TREAT AN ANEURYSM UTILIZING THE GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS. IT WAS REPORTED THAT THE AORTIC EXTENDER DID NOT DEPLOY AS INTENDED. THE PROCEDURE WAS PERFORMED EMERGENTLY DUE TO A RUPTURED ABDOMINAL AORTIC ANEURYSM (AAA), AND THE INFRARENAL NECK DID NOT MEET THE OPTIMAL CRITERIA OUTLINED IN THE INSTRUCTIONS FOR USE (IFU), MEASURING APPROXIMATELY 6 TO 7 MM IN LENGTH. UPON FULL DEPLOYMENT, THE EXTENDER DID NOT ALIGN COAXIALLY WITH EITHER THE IPSILATERAL LIMB OR THE AORTA. THE DEPLOYMENT OCCURRED SLIGHTLY FASTER THAN THE FSA WOULD HAVE PREFERRED. THE DEVICE APPEARED DISTORTED ON THE PROXIMAL AND DISTAL END, EXHIBITING SIGNS OF INFOLDING AND/OR SCRUCHING. TO ADDRESS THIS, AN ADDITIONAL PROXIMAL AORTIC EXTENDER WAS PLACED, AND BALLOONING WAS PERFORMED THROUGHOUT THE SYSTEM. THERE WAS NO UNINTENTIONAL COVERAGE OF ADJACENT VESSELS. THERE WAS NO PATIENT HARM OR ADVERSE EVENT. THE PHYSICIAN DOES NOT BELIEVE THE ISSUE WAS DUE TO ANATOMICAL CONSTRAINTS. AT THE DISTAL SITE OF INFOLDING, THERE WERE NO SIGNIFICANT ANGULATIONS. THE ROOT CAUSE OF THE D

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22395245 ↗
• InjuryApr 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING WAS REPORTED: ON (B)(6) 2025, THE PATIENT WAS IMPLANTED WITH GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESES TO TREAT A RUPTURED ABDOMINAL AORTIC ANEURYSM. REPORTEDLY THE PATIENT HAD A ¿SHORT¿ AORTIC NECK. IT WAS REPORTED THAT ALL DEVICES WERE IMPLANTED BUT THERE WAS NOT A GOOD SEAL AT THE PROXIMAL AORTIC NECK, DUE TO AORTIC NECK ANATOMY. THE PHYSICIAN CHOSE TO EXPLANT THE IMPLANTED DEVICES AND CONVERTED TO AN OPEN REPAIR. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Ruptured Aneurysm

  MAUDE report 21768491 ↗
• InjuryApr 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING WAS REPORTED: ON (B)(6) 2025, THE PATIENT WAS IMPLANTED WITH GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESES TO TREAT A RUPTURED ABDOMINAL AORTIC ANEURYSM. REPORTEDLY THE PATIENT HAD A ¿SHORT¿ AORTIC NECK. IT WAS REPORTED THAT ALL DEVICES WERE IMPLANTED BUT THERE WAS NOT A GOOD SEAL AT THE PROXIMAL AORTIC NECK, DUE TO AORTIC NECK ANATOMY. THE PHYSICIAN CHOSE TO EXPLANT THE IMPLANTED DEVICES AND CONVERTED TO AN OPEN REPAIR. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Ruptured Aneurysm

  MAUDE report 21768131 ↗
• InjuryMar 20, 2025No Apparent Adverse Event; No Apparent Adverse Event

  THE FOLLOWING WAS REPORTED TO GORE ON (B)(6) 2025 FROM THE IMEDIDATA STUDY DATABASE: ON (B)(6) 2025, THIS 85-YEAR-OLD MALE PATIENT UNDERWENT ENDOVASCULAR TREATMENT AS A REINTERVENTION PROCEDURE FOR AN ENDOLEAK TYPE II OF A PRIOR ENDOVASCULAR PROCEDURE FOR AN ABDOMINAL AORTIC AND ILIAC ANEURYSM. THE PATIENT WAS TREATED WITH AN UNKNOWN GORE® EXCLUDER® ENDOPROSTHESIS BY CUT-DOWN AND CONDUIT. THE GORE® DEVICES WERE SUCCESSFULLY NAVIGATED TO THE INTENDED LOCATION AND SUCCESSFULLY DEPLOYED. THE SITES WERE ACCESSED PERCUTANEOUSLY. DEVICE CATHETERS WERE SUCCESSFULLY REMOVED AFTER SUCCESSFUL ACCESS, DELIVERY AND DEPLOYMENT OF THE DEVICES. THERE WAS AN ADDITIONAL PROCEDURE OF UNKNOWN TYPE. THERE WAS NO TYPE I OR TYPE II ENDOLEAKS OBSERVED AT THE CONCLUSION OF THE PROCEDURE. ON (B)(6) 2025, IT WAS NOTED THE PATIENT HAD A ¿MILD STROKE¿ RELATED TO THE PROCEDURE. NO INTERVENTION WAS NECESSARY.

  Patient problems: Stroke/CVA

  MAUDE report 21658126 ↗
• InjuryFeb 5, 2025Entrapment of Device; Entrapment of Device

  ON (B)(6) 2021, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR INFRARENAL ABDOMINAL AORTIC ANEURYSM AND WAS IMPLANTED WITH GORE® EXCLUDER® AAA ENDOPROSTHESIS FEATURING C3® DEPLOYMENT SYSTEM (RLT351414/ (B)(6). THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2024, THE PATIENT UNDERWENT REINTERVENTION FOR A PROXIMAL TYPE I ENDOLEAK. A SNORKEL/CHIMNEY PROCEDURE WAS PERFORMED WITH PLACEMENT OF A GORE® EXCLUDER® CONFORMABLE AORTIC EXTENDER ENDOPROSTHESIS CXA360005/ (B)(6) AND A GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICE). THE VBX DEVICE WAS EXTENDED INTO THE LEFT RENAL ARTERY. THE PATIENT TOLERATED THE PROCEDURE AND THE ENDOLEAK WAS RESOLVED. ON (B)(6) 2025, THE PHYSICIAN PROVIDED IMAGING TO GORE FOR EVALUATION OF A PROXIMAL TYPE I ENDOLEAK/GUTTER LEAK. THE LEAK APPEARS TO ORIGINATE AROUND WHERE THE STENT (BXB065902A/ (B)(6) TRAVELS NORTH OF THE A GORE® EXCLUDER® CONFORMABLE AORTIC EXTENDER ENDOPROSTHESIS INTO THE LEFT RENAL ARTERY. ADDITIONALLY, ANEURYSM ENLARGEMENT FROM 5.5 CM TO 6.2 CM IS INDICATED ON THE RADIOLOGY REPORT. AT THIS TIME THERE IS NO REINTERVENTION SCHEDULED OR PLANNED FOR THE PATIENT. THE EVENT IS ONGOING.

  Patient problems: Clinical Endoleak

  MAUDE report 21316096 ↗
• DeathJun 14, 2024Adverse 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) 2024, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF A RUPTURED ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESES AND GORE® EXCLUDER® AAA ENDOPROSTHESIS. IT WAS REPORTED THAT THE PATIENT ADMITTED TO THE EMERGENCY DEPARTMENT AND WAS UNSTABLE. AFTER IMPLANTING THE TRUNK-IPSILATERAL LEG ENDOPROSTHESIS, A TYPE I ENDOLEAK WAS PRESENT. MULTIPLE AORTIC EXTENDER ENDOPROSTHESES WERE IMPLANTED TO TRY TO RESOLVE THE ENDOLEAK. THE PROXIMAL TYPE I ENDOLEAK REMAINED AND THE PHYSICIAN CHOSE TO CONVERT TO AN OPEN REPAIR. DURING THE OPEN REPAIR THE PATIENT CODED AND COULD NOT BE REVIVED. THE PATIENT EXPIRED DURING THE OPEN REPAIR. THE PHYSICIAN REPORTED THAT TOO MUCH BLOOD HAD BEEN LOST AND THERE WAS A RUPTURE AT THE RENAL ARTERIES. IT IS UNKNOWN IF THE IMPLANT OF ONE OF THE GORE ENDOPROSTHESIS CAUSED THE RUPTURE AT THE RENAL ARTERIES. THE FSA WAS NOT PRESENT AT THE PROCEDURE. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Clinical Endoleak

  MAUDE report 19543568 ↗
• InjuryJun 12, 2024Fluid/Blood Leak; Fluid/Blood Leak

  ON (B)(6) 2015, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF A PRIOR ENDOVASCULAR REPAIR WITH A MEDTRONIC AFIX GRAFT AND A VELA CUFF. GORE® EXCLUDER®AAA ENDOPROSTHESIS WERE IMPLANTED TO TREAT A PROXIMAL TYPE I ENDOLEAK DUE TO SUSPECTED MIGRATION OF THE MEDTRONIC DEVICES. PRE-TREATMENT MAXIMUM AORTIC DIAMETER MEASURED 52MM. ON (B)(6) 2024, THE SITE REPORTED THE PATIENT HAD A TYPE III ENDOLEAK. ON (B)(6) 2024, THE PATIENT UNDERWENT OTHER TREATMENT OR PROCEDURE FOR THE TYPE III ENDOLEAK. THE PATIENT TOLERATED THE PROCEDURE. ADDITIONAL DETAILS HAVE BEEN REQUESTED.

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

  MAUDE report 19525174 ↗
• InjuryJun 5, 2024Malposition of Device; Malposition of Device

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2024, A PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS. DURING THE TREATMENT, THE AORTIC EXTENDER WAS DEPLOYED PROXIMALLY MORE THAN INTENDED AND THE LEFT RENAL ARTERY WAS COVERED APPROXIMATELY 3/4 UNINTENTIONALLY. FOR TREATMENT, ADDITIONAL STENTS WERE IMPLANTED INTO THE LEFT RENAL ARTERY. BLOOD FLOW INTO THE LEFT RENAL ARTERY WAS IMPROVED. THE PATIENT TOLERATED THE PROCEDURE. THE PHYSICIAN STATED THAT HE WAS PREPARED FOR THE AORTIC EXTENDER TO COVER ABOUT 1/3 OF THE RENAL ARTERY TO AVOID THE DEVICE REMAINING IN THE SACCULAR REGION, BUT IT IMPLANTED MORE PROXIMALLY THAN EXPECTED.

  Patient problems: Obstruction/Occlusion

  MAUDE report 19465279 ↗
• InjuryMay 22, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  THE FIELD SALES ASSOCIATE (FSA) REPORTED THE FOLLOWING: ON (B)(6) 2024, THE PATIENT WAS IMPLANTED WITH GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESES TO TREAT A RUPTURED ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT THE PATIENT WAS ADMITTED EMERGENTLY WITH A RUPTURED ABDOMINAL AORTIC ANEURYSM. THE PATIENT HAD AN EXTREMELY ANGULATED AORTIC NECK. WHILE DEPLOYING THE TRUNK-IPSILATERAL LEG ENDOPROSTHESIS THE DEVICE MIGRATED APPROXIMATELY 5MM BELOW THE LEFT RENAL ARTERY (LOWEST RENAL ARTERY). THIS RESULTED IN A PROXIMAL TYPE I ENDOLEAK. THE PHYSICIAN IMPLANTED A CONFORMABLE AORTIC EXTENDER ENDOPROSTHESIS TO TREAT THE ENDOLEAK. THE DEVICE ALSO MIGRATED DISTALLY INTO THE PROXIMAL PORTION INSIDE THE NECK OF THE TRUNK-IPSILATERAL LEG ENDOPROSTHESIS. THE PROXIMAL TYPE I ENDOLEAK REMAINED. THE PHYSICIAN IMPLANTED A SECOND AORTIC EXTENDER ENDOPROSTHESIS AND BALLOONED. THERE WAS A SLIGHT BLUSHING DURING THE FINAL ANGIOGRAM, THE PROXIMAL TYPE I ENDOLEAK REMAINED. REPORTEDLY, THE FINAL ANGIOGRAPHY IMAGES WERE POOR QUALITY DUE TO THE PATIENT¿S OBESITY. BOTH A PROXIMAL TYPE I AND A DISTAL TYPE I ENDOLEAK REMAINED. ONE UNIT OF BLOOD WAS GIVEN DURING THE PROCEDURE DUE TO THE RUPTURED ANEURYSM UPON

  Patient problems: Clinical Endoleak

  MAUDE report 19371385 ↗
• MalfunctionApr 22, 2024Activation Failure; Activation Failure

  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. THE TRUNK - IPSILATERAL LEG ENDOPROSTHESIS WAS DEPLOYED APPROXIMATELY 2 CM DISTAL TO THE LOWER RENAL ARTERY. WHEN THE AORTIC EXTENDER ENDOPROSTHESIS WAS DEPLOYED ON THE PROXIMAL SIDE, INSUFFICIENT DEPLOYMENT WAS OBSERVED. ATTEMPTS WERE MADE TO GET FULL DEPLOYMENT USING A BALLOON CATHETER OR INSERT A WIRE INTO THE GAP, BUT THESE WERE UNSUCCESSFUL. NO ENDOLEAK WAS OBSERVED. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Insufficient Information

  MAUDE report 19161071 ↗
• InjuryApr 8, 2024Malposition of Device; Malposition of Device

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2024, A PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS AND GORE® EXCLUDER® AAA ENDOPROSTHESES. AFTER ALL STENT GRAFTS WERE IMPLANTED, AN ANGIOGRAPHY REVEALED THAT THE AORTIC EXTENDER OF GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS WAS UNINTENTIONALLY COVERED 4/5 OF THE LEFT RENAL ARTERY AND SLOW FLOW WAS OBSERVED. ADDITIONALLY, A STENT WAS IMPLANTED INTO THE LEFT RENAL ARTERY. AN ANGIOGRAPHY REVEALED THAT THE BLOOD FLOW TO THE LEFT RENAL ARTERY WAS RESOLVED. THE PATIENT TOLERATED THE PROCEDURE. THE PHYSICIAN STATED THAT IT WAS VERY DIFFICULT TO DETERMINE THE LEFT RENAL ARTERY USING C-ARM BECAUSE THE PROXIMAL NECK WAS HIGHLY TORTUOUS.

  Patient problems: Obstruction/Occlusion

  MAUDE report 19068762 ↗
• MalfunctionDec 22, 2023Human-Device Interface Problem; Human-Device Interface Problem

  THE FIELD SALES ASSOCIATE (FSA) REPORTED THE FOLLOWING: ON (B)(6) 2023, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF A PSEUDOANEURYSM IN THE ASCENDING AORTA USING GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESES. IT WAS REPORTED AS THE FELLOW PHYSICIAN WAS DEPLOYING THE GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESES (AORTIC EXTENDER), SHE PAUSED (LOOKED UP AT THE SCREEN IN ORDER TO IDENTIFY PLACEMENT LOCATION) MIDWAY THROUGH THE DEPLOYMENT PULL. THE DEVICE DID DEPLOY AND ¿HAD THE APPEARANCE OF BEING AT A ANGLE AND FOLDING BACK ON ITSELF¿. ¿THE AORTIC EXTENDER APPEARED TO TUMBLE AT THE DISTAL END OF THE DEVICE AND SAT AT AN ANGLE IN THE AORTA.¿ A ADDITIONAL GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESES (AORTIC EXTENDER) WAS THEN DEPLOYED/IMPLANTED SUCCESSFULLY. THE PATIENT TOLERATED THE PROCEDURE. THE FSA REPORTED THAT THERE WAS AN OBVIOUS PAUSE DURING THE DEPLOYMENT. THE FELLOW MADE A CLAIM THAT THE DEPLOYMENT MECHANISM WAS "STUCK" AND THAT CAUSED THE PAUSE IN DEPLOYMENT. HOWEVER, THE FSA WITNESSED THE FELLOW PAUSE TO LOOK UP AT THE SCREEN TO IDENTIFY PLACEMENT LOCATION OF THE AORTIC EXTENDER AND THAT WAS WHAT INSTITUTED THE "PAUSE" IN DEPLOYMENT.

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

  MAUDE report 18387768 ↗
• InjuryDec 18, 2023Unintended Movement; Migration; Unintended Movement; Migration

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2015, THIS PATIENT UNDERWENT EMARGENCY ENDOVASCULAR TREATMENT FOR AN IMMINENT RUPTURE OF AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESIS. A TRUNK - IPSILATERAL LEG ENDOPROSTHESIS (RLT261412J) WAS IMPLANTED FROM UNDER THE RENAL ARTERIES. THE PATIENT TOLERATED THE PROCEDURE. ON AN UNKNOWN DATE, MIGRATION OF THE RLT261412J TO THE DISTAL SIDE (DISTANCE: APPROXIMATELY 25 MM) WAS OBSERVED. ON (B)(6) 2023, A REINTERVENTION WAS PERFORMED USING GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS. AORTIC EXTENDER ENDOPROSTHESIS (CXA360005) WAS TO BE IMPLANTED PROXIMALLY TO THE MIGRATED RLT261412J OVERLAPPING 2CM. HOWEVER, DURING DEPLOYMENT OF THE CXA360005 FROM UNDER THE RENAL ARTERY, IT MOVED TO PROXIMALLY, RESULTING PARTIAL COVERAGE OF THE RIGHT RENAL ARTERY. REPORTEDLY, THE PHYSICIAN DEPLOYED THE CXA360005 SLOWLY (SLOW DEPLOY). ALSO IT WAS REPORTED THAT THE CXA360005, WHICH BEGAN SLOWLY DEPLOYING FROM ONE SIDE OF THE DISTAL (CXA360005 IS DEPLOYED FROM DISTAL ONE SIDE, SO USUALLY IT LOOKED AS IF IT WAS TEMPORARILY LIFTED ONE SIDE), HIT THE RLT261412J DURING FULL DEPLOYMENT, CAUSING IT TO JAMP PROXIMALLY. BECAUSE THE

  Patient problems: Obstruction/Occlusion; Renal Impairment

  MAUDE report 18344730 ↗
• InjuryAug 2, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  ON (B)(6) 2023, A PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESES. DURING THE TREATMENT AN INTERNAL ILIAC GATE OF AN ILIAC BRANCH COMPONENT WAS UNINTENTIONALLY DEPLOYED IN A LEFT EXTERNAL ILIAC ARTERY. ATTEMPT WAS MADE TO PUSH IT UP, HOWEVER IT WAS UNSUCCESSFUL. AN AORTO-UNI-ILIAC WAS CREATED USING A CONTRALATERAL LEG THAT WAS IMPLANTED UPSIDE DOWN. THE PATIENT TOLERATED THE PROCEDURE. THE PHYSICIAN STATED THAT AFTER MARKING, IT SHOULD HAVE BEEN CHECKED AGAIN WITH AN ANGIOGRAPHY. REPORTEDLY, THE MARKING FOR THE LEFT INTERNAL ILIAC ARTERY WAS MISPLACED. ADDITIONAL INFORMATION FROM THE FSA WAS PROVIDED: AFTER THE PROCEDURE ON (B)(6) 2023, THE PATIENT COMPLAINED OF PAIN, AND A COMPUTED TOMOGRAPHY ANGIOGRAPHY REVEALED A RETROGRADE DISSECTION FROM THE PROXIMAL NECK TO THE DISTAL ARCH. THE PATIENT WAS STABLE WITH MEDICATION. THE PHYSICIAN STATED THAT HE TOUCHED UP TOO MUCH ON THE PROXIMAL NECK AT THE PROCEDURE. DURING THE PROCEDURE, THE DISSECTION WAS NOT OBSERVED. FSA STATED THAT THE PROXIMAL NECK WAS IN POOR CONDITION DUE TO DISSECTION. AS THE FIRST REPORT, THE IBE DEVICE WAS PUSHED UP TO FIX THE LOCATION. AT TH

  Patient problems: Vascular Dissection

  MAUDE report 17446236 ↗
• InjuryJul 24, 2023Patient-Device Incompatibility; Patient-Device Incompatibility

  ON (B)(6) 2022, THE PATIENT UNDERWENT REINTERVENTION FOR A TYPE I ENDOLEAK ON AN UNKNOWN DEVICE PLACED ON AN UNKNOWN DATE. TWO GORE® EXCLUDER® CONFORMABLE AAA AORTIC EXTENDER COMPONENTS (CXA) WERE IMPLANTED PROXIMALLY TO TREAT THE TYPE I ENDOLEAK. ON (B)(6) 2023, THE PATIENT PRESENTED EMERGENTLY WITH A RUPTURED ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT AN UNKNOWN ENDOLEAK WAS OBSERVED, AND APPEARED TO BE EITHER A TYPE I OR TYPE III ENDOLEAK. THE PATIENT'S AORTIC ANGLE WAS REPORTED AS 90 DEGREES. IT WAS REPORTED THAT THE PATIENT WAS NOT A CANDIDATE FOR OPEN PROCEDURE. THEREFORE, TWO ADDITIONAL CXA DEVICES AND TWO GORE® EXCLUDER® AAA AORTIC EXTENDER COMPONENTS WERE IMPLANTED TO TREAT THE RUPTURE. THE RUPTURE WAS SUCCESSFULLY TREATED. THERE WERE NO FURTHER REPORTED ISSUES. THE PATIENT TOLERATED THE REINTERVENTION.

  Patient problems: Ruptured Aneurysm

  MAUDE report 17378900 ↗
• InjuryJul 10, 2023Positioning Problem; Positioning Problem

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2023, THE PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE IN ZONE 9-INFRARENAL TO TREAT AN AORTIC ANEURYSM UTILIZING GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS (AORTIC EXTENDER, TRUNK IPSILATERAL LEG), AND GORE® EXCLUDER® AAA ENDOPROSTHESIS (CONTRALATERAL LEG). REPORTEDLY, THE AORTIC EXTENDER HAD TO BE OPENED UP IN THE CASE AS THE MAIN BODY'S (TRUNK IPSILATERAL LEG) CONSTRAINING LOOP MALFUNCTIONED AND THE MAIN BODY TRUNK DEVICE HAD TO BE PULLED DOWN A LITTLE. THE REASON BEING THAT ONE OF THE STENTS ON THE PROXIMAL TOP SIDE OF THE TRUNK WAS FLIPPED OR INVERTED, AND NOT UPRIGHT. PHYSICIAN TRIED PULLING IT DOWN A BIT TO GET THE STENT TO UNFLIP AND STRAIGHTEN BUT IT WOULD NOT OPEN UP AS THE CONSTRAINING MECHANISM BROKE AT WHICH POINT THEY PUT A MOB BALLOON IN AND INFLATED IT THAT LED TO THE TRUNK IPSI BEING OPENED BACK UP, HOWEVER, THE DEVICE WAS BIT BELOW THE RENALS FROM THE INTENDED LANDING ZONE AS THEY HAD PULLED IT DOWN AND AN AORTIC EXTENDER WAS PUT IN TO EXTEND PROXIMALLY TO RENALS. HOWEVER, THE AORTIC EXTENDER WHILE IT LANDED PERFECTLY AT THE INTENDED LANDING ZONE BELOW THE RENALS, IT SLID DOWN 15MM INTO THE MAIN BODY OF TRUNK IPSI L

  Patient problems: Aneurysm

  MAUDE report 17286911 ↗
• InjuryApr 17, 2023Migration; Migration

  THE PATIENT PRESENTED WITH AN INFRARENAL AORTIC ANEURYSM AND WAS TREATED ON (B)(6) 2015 USING THE GORE EXCLUDER WITH C3 DELIVERY SYSTEM AND TWO GORE® EXCLUDER® AAA ENDOPROSTHESES. THE PATIENT TOLERATED THE PROCEDURE. THE PHYSICIAN COMPLETED AN ANGIOGRAM ON (B)(6) 2021 TO ATTEMPT TO IDENTIFY A POSSIBLE ENDOLEAK (TYPE 1A OR TYPE 2) ON PATIENT. THE PHYSICIAN BELIEVED A TYPE 1A ENDOLEAK WAS PRESENT AND DECIDED TO TREAT. THE PHYSICIAN HAD DONE A SECOND PROCEDURE USING TWO GORE® EXCLUDER® AAA ENDOPROSTHESES. THE AORTIC EXTENSION CUFFS WERE PLACED SUCCESSFULLY, AND THE PATIENT TOLERATED THE PROCEDURE WELL. SEE CASE (B)(4). THE PATIENT PRESENTED ON (B)(6) 2023 WITH AN EXPANDING ANEURYSM (>1CM IN GROWTH SINCE 2021) AND A PROXIMAL TYPE 1A ENDOLEAK. DUE TO ADDITIONAL DISEASE IN THE PROXIMAL NECK, AND SOME NECK ANGULATION, THE SEAL IN THE PROXIMAL NECK WAS LOST AND ORIGINAL SYSTEM HAD APPEARED TO DROP APPROXIMATELY 3CM. THREE GORE® EXCLUDER® AAA ENDOPROSTHESS WERE PLACED AS PROXIMAL EXTENSIONS FROM THE TOP OF THE CURRENT SYSTEM AND EXTENDED TO THE RENALS. SEAL WAS ATTAINED IN THE PROXIMAL NECK FOLLOWING PLACEMENT OF THESE CUFFS. PATIENT TOLERATED THE PROCEDURE WELL AND IS REPORTED TO BE DOING

  Patient problems: Clinical Endoleak

  MAUDE report 16752286 ↗
• InjuryMar 1, 2023Malposition of Device; Malposition of Device

  ON AN UNKNOWN DATE (2-3 YEARS AGO), THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR A RIGHT INTERNAL ILIAC ARTERY ANEURYSM USING ENDURANT¿ STENT GRAFTS. ON (B)(6) 2023, THE PATIENT PRESENTED WITH ABDOMINAL PAIN, AND A PROXIMAL TYPE I ENDOLEAK AND A IMPENDING RUPTURE OF AN ABDOMINAL AORTIC ANEURYSM WERE IDENTIFIED. ON (B)(6) 2023: THE PATIENT UNDERWENT RE-INTERVENTION USING GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESES AND GORE® EXCLUDER® AAA ENDOPROSTHESES. A CXA360005 WAS DEPLOYED FROM JUST BELOW THE LEFT RENAL ARTERY, BUT AFTER DEPLOYMENT IT MOVED DISTALLY TO THE ENDURANT¿ IMPLANTED POSITION. A SECOND CXA360005 WAS DEPLOYED OVER (PARTIALLY) THE LEFT RENAL ARTERY. (IT IS UNKNOWN IF THERE WAS A LEFT RENAL ARTERY PARTIAL OBSTRUCTION BY THE CXA360005 OR NOT AFTER DEPLOYMENT.) HOWEVER, THE PROXIMAL TYPE I ENDOLEAK REMAINED. REPORTEDLY, AN OPEN SURGERY WAS CONSIDERED AS THE BEST FOR REPAIR OF THE PROXIMAL TYPE I ENDOLEAK ORIGINALLY, HOWEVER, THE PATIENT WAS DEEMED UNFIT FOR AN OPEN SURGERY DUE TO AN UNKNOWN DISEASE CONDITION. IT WAS ALSO REPORTED THAT THE PATIENT'S PROXIMAL NECK WAS ANGULATED. ON (B)(6) 2023, FOR REPAIR THE ENDOLEAK, THE PATIENT UNDERWENT SECOND RE-INTERVENTION. EXP

  Patient problems: Clinical Endoleak; Obstruction/Occlusion

  MAUDE report 16463253 ↗