GORE EXCLUDER Conf AAA Endo - Aortic Extender CXA280005Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 00733132650958), received between Dec 13, 2022 and Aug 4, 2026 — classified as 1 death, 17 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Migration” (5 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 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• DeathAug 4, 2026Adverse Event Without Identified Device or Use Problem

  The following information was reported to Gore:On (b)(6) 2026, a patient underwent an emergency endovascular procedure to treat a ruptured abdominal aortic aneurysm using GORE® EXCLUDER® AAA Endoprosthesis system devices and GORE® EXCLUDER® Conformable AAA Endoprosthesis devices.The endovascular procedure itself was completed, and the patient tolerated the procedure. After the endovascular procedure, open surgery was performed for decompression and removal of the hematoma.During the open surgery, the right leg was reported to possibly be disconnected from the right common iliac artery. The physician tried to extend the stent graft to the external iliac artery; however, the patient's condition suddenly took a turn for the worse, and the patient died. The most distal device of the right leg was the aortic extender.Gore FSA was not present at the procedure. No comment was obtained from the physician regarding a causal relationship between the device and the patient¿s death.

  Patient problems: Insufficient Information

  MAUDE report 50125657 ↗
• InjuryMay 14, 2026Migration

  ON (B)(6) 2026, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM AND WAS IMPLANTED WITH GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS WITH ACTIVE CONTROL SYSTEM DEVICES. A GORE® EXCLUDER® CONFORMABLE AORTIC EXTENDER WAS PLACED TO EXTEND THE TRUNK COMPONENT; HOWEVER, DURING BALLOONING, THE EXTENDER MIGRATED DISTALLY (DISTANCE UNKNOWN), RESULTING IN A PROXIMAL TYPE I ENDOLEAK. AN ADDITIONAL GORE® EXCLUDER® AORTIC EXTENDER ENDOPROSTHESIS WAS THEN IMPLANTED PROXIMALLY, WHICH RESOLVED THE ENDOLEAK. IT WAS NOTED THAT THE SECOND AORTIC EXTENDER PARTIALLY COVERED THE RENAL ARTERY, BUT BLOOD FLOW REMAINED UNOBSTRUCTED. THE PHYSICIAN ELECTED TO LEAVE THE DEVICE IN PLACE AND CONCLUDED THE PROCEDURE. THE PATIENT INITIALLY TOLERATED THE PROCEDURE; HOWEVER, HER BLOOD PRESSURE SUBSEQUENTLY DECREASED DUE TO INADEQUATE GROIN CLOSURE. SHE WAS RETURNED TO THE OPERATING ROOM FOR ADDITIONAL CLOSURE. AT THE TIME OF THE REPORT, THE PATIENT REMAINED IN THE OPERATING ROOM WHILE THE TEAM WORKED TO ACHIEVE ADEQUATE GROIN CLOSURE. THIS GROIN COMPLICATION WAS NOT RELATED TO THE GORE DEVICES BUT WAS PROCEDURAL IN NATURE. ON (B)(6) 2026, THE PHYSICIAN REPORTED THAT THE PATIENT WAS

  Patient problems: Aneurysm

  MAUDE report 25176211 ↗
• InjuryMay 1, 2026Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING WAS REPORTED: ON (B)(6) 2026, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF A DISSECTION AT THE ABDOMINAL AORTA USING A GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE) DEVICE SYSTEM. REPORTEDLY, DURING THE PROCEDURE, BETWEEN STENTING THE RIGHT AND LEFT RENAL ARTERIES, THE PATIENT DEVELOPED A DISSECTION THROUGHOUT THE THORACIC AORTA. THE CELIAC, SMA, AND RIGHT RENAL ARTERIES WERE ALL SUCCESSFULLY STENTED PRIOR TO THIS. THE PHYSICIANS ELECTED TO PLUG THE LEFT RENAL PORTAL AS THE LEFT RENAL ARTERY WAS NO LONGER FILLING. AN AORTIC EXTENDER WAS USED TO EXTEND THE TAMBE DEVICE DISTALLY AND SEAL IN THE PRIOR SURGICAL GRAFT. THE PROCEDURE WAS ABORTED, AND THE PATIENT WAS TAKEN FOR A STAT CT SCAN. THIS SHOWED A DISSECTION FROM THE LEVEL OF THE LEFT SUBCLAVIAN ARTERY EXTENDING THROUGH THE TAMBE TREATMENT ZONE. THE TAMBE DEVICE WAS ALSO COMPRESSED FROM THE FALSE LUMEN. IT WAS REPORTED THAT THE PHYSICIANS FELT THIS WAS LIKELY DUE TO TRAUMA FROM THE AXILLARY SHEATH, WHICH WAS A DSF1233. THE PATIENT WAS TAKEN BACK TO THE OR FOR OPEN SURGICAL REPAIR. THE PATIENT RESPONDED WELL TO THE FROZEN ELEPHANT TRUNK (FET) OPEN CONVERSION. THE TRUE LUMEN OPENED UP AND DISTAL PU

  Patient problems: Vascular Dissection

  MAUDE report 25061622 ↗
• InjuryMar 23, 2026Improper or Incorrect Procedure or Method; Migration; Device Endoleak

  ON (B)(6) 2024, THE PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA) UTILIZING GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS (CXT281412 AND CXA280005). ON (B)(6) 2026, THE PATIENT HAD AN EVALUATION FOR THE AAA WHERE IT WAS DETERMINED THAT THE PROXIMAL GRAFT (CXA280005) HAD MIGRATED ABOUT 3MM DISTALLY AND THERE WAS A TYPE IA ENDOLEAK. AT THE EVALUATION, THE ANEURYSM WAS MEASURING AT 5.7 CM; HOWEVER, THERE WAS REPORTEDLY NO ANEURYSM ENLARGEMENT ASSOCIATED WITH THE ENDOLEAK. THE REPORTED CAUSE FOR THE MIGRATION AND ENDOLEAK WAS THE PATIENT'S ANATOMY (HIGHLY ANGLED, REVERSE TAPER, DISEASED AORTIC NECK). THE PATIENT'S AORTIC NECK MEASURED APPROXIMATELY 17.2-25.3 MM OVER 10 MM OF LENGTH, AND THE AORTIC NECK ANGULATION WAS APPROXIMATELY 30 DEGREES. REPORTEDLY, THE PATIENT HAD NO ABDOMINAL PAIN BUT HAD CHRONIC BACK PAIN. THE PHYSICIAN PLANNED TO TREAT THE ENDOLEAK BY COVERING THE RENAL ARTERIES AND RELINING THE ENTIRE EXISTING GRAFT UP TO THE PATIENT'S SUPERIOR MESENTERIC ARTERY (SMA). IT WAS REPORTED THE PATIENT HAS END-STAGE RENAL DISEASE AND IS ALREADY ON HEMODIALYSIS. ON (B)(6) 2026, THE PATIENT UNDERWENT A REINTERVENTION PROCEDURE TO TREAT THE E

  Patient problems: Clinical Endoleak; Pain

  MAUDE report 24664223 ↗
• InjuryMar 12, 2026No Apparent Adverse Event

  THE FOLLOWING EVENT IS FROM THE AAA 24-01 TAMBE POST APPROVAL STUDY AND INFORMATION WAS OBTAINED FROM THE IMEDIDATA CLINICAL DATABASE: ON JULY 8, 2025, A PATIENT WAS TREATED FOR A THORACOABDOMINAL AORTIC ANEURYSM USING A GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE) SYSTEM OF COMPONENTS. ON JULY 9, 2025, A STROKE WAS REPORTED. REPORTEDLY, THE STROKE WAS PROCEDURE RELATED, AND REQUIRED EXTENDED HOSPITALIZATION, BUT NO TREATMENT. THE PATIENT WAS DISCHARGED ON JULY 18, 2025. AT DISCHARGE, ALL ITEMS ON THE NIH STROKE SCALE WERE RECORDED AS 0.

  Patient problems: Stroke/CVA

  MAUDE report 24581101 ↗
• InjuryFeb 27, 2026Device-Device Incompatibility

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2023, THIS PATIENT UNDERWENT AN ENDOVASCULAR TREATMENT FOR ANASTOMOTIC PSEUDOANEURYSM OF THE PREVIOUSLY IMPLANTED GRAFT USING GORE® EXCLUDER® AAA ENDOPROSTHESIS (AORTIC EXTENDER ALONE). TWO AORTIC EXTENDERS WERE IMPLANTED. ON (B)(6) 2026, A NEW PSEUDOANEURYSM DEVELOPED AT THE DISTAL ANASTOMOSIS OF THE RIGHT COMMON ILIAC ARTERY AND IT WAS RUPTURED, RESULTING IN AN EMERGENCY PROCEDURE REQUEST. UPON EVALUATION, ANOTHER PSEUDOANEURYSM WAS ALSO IDENTIFIED AT THE DISTAL ENDO OF THE PREVIOUSLY IMPLANTED AORTIC EXTENDER, WITH ENLARGEMENT OF THE ANEURYSM. TWO STENT GRAFTS WERE IMPLANTED IN THE RIGHT ILIAC ARTERY TO COVER THE RUPTURED ANEURYSM AND AN ADDITIONAL AORTIC EXTENDER OF GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS WAS IMPLANTED DISTAL TO THE PREVIOUS DEVICES. THE FINAL ANGIOGRAPHY SHOWED A TYPE III ENDOLEAK ON THE AORTIC EXTENDERS, BUT NO FURTHER TREATMENT WAS GIVEN. IT WAS LEFT FOR MONITORING. THE PATIENT TOLERATED THE PROCEDURE. THE REPORTING PHYSICIAN COMMENTED AS FOLLOWS: THE PSEUDOANEURYSM MIGHT HAVE BEEN CAUSED BY CONTACT BETWEEN THE EDGE OF THE DISTAL END OF THE AORTIC EXTENDER AND THE VASCULAR GRAFT. ON (B)(6) 2026

  Patient problems: Clinical Endoleak

  MAUDE report 24467895 ↗
• InjuryJan 6, 2026Patient-Device Incompatibility

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2025, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS AND GORE® EXCLUDER®AAA ENDOPROSTHESIS DEVICES. ANGIOGRAPHY AFTER STENT GRAFT PLACEMENT, A PROXIMAL TYPE I ENDOLEAK OR TYPE II ENDOLEAK WAS OBSERVED. THE PATIENT WAS DECIDED TO BE MONITORED, AND THE PROCEDURE WAS COMPLETED. REPORTEDLY THAT THE PATIENT HAD UNDERGONE PCI AND WAS ON ANTICOAGULANT THERAPY. IT WAS ALSO REPORTED THAT COLLATERAL FLOW MIGHT HAVE CONTRIBUTED TO THE ENDOLEAK. <ADDITIONAL INFORMATION RECEIVED ON DECEMBER 12, 2025> ON (B)(6) 2025, AORTIC RUPTURE OCCURRED AT THE PROXIMAL NECK. AS A TREATMENT, A NON-GORE STENT GRAFT CUFF WAS DEPLOYED JUST BELOW THE SUPERIOR MESENTERIC ARTERY. AN AORTIC EXTENDER COMPONENT WAS ADDITIONALLY IMPLANTED DISTAL TO THE NON-GORE CUFF TO COMPLETE THE PROCEDURE. NO COMMENTS REGARDING THE CAUSE OF THE EVENT HAVE BEEN OBTAINED FROM THE PHYSICIAN.

  Patient problems: Clinical Endoleak; Perforation of Vessels

  MAUDE report 23971176 ↗
• InjuryJul 2, 2025Adverse 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 IMPLANTED WITH A GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS TO TREAT AN ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT IMAGES (DATE AND MODALITY IS UNKNOWN) REVEALED A PROXIMAL TYPE I ENDOLEAK. NO ANEURYSM SAC ENLARGEMENT. ON (B)(6) 2025, THERE WAS A REINTERVENTION. THE PHYSICIAN IMPLANTED TWO ADDITIONAL GORE® EXCLUDER® CONFORMABLE AAA AORTIC EXTENDER ENDOPROSTHESES. THE ENDOLEAK WAS RESOLVED AND THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Clinical Endoleak

  MAUDE report 22385687 ↗
• InjuryJan 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2022, THIS PATIENT UNDERWENT EMERGENCY ENDOVASCULAR TREATMENT FOR A RUPTURED ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESES. DURING THE PROCEDURE, A TOTAL OF 13 DEVICES, INCLUDING TWO CONTRALATERAL LEG ENDOPROSTHESIS (PLC141000J, PLC141400J) AND AN ILIAC EXTENDER ENDOPROSTHESIS (PLL161407J) WERE IMPLANTED. ON THE SAME DAY, AFTER THE PROCEDURE, CT SHOWED A SMALL BUT APPARENT TYPE IIIA ENDOLEAK. ON (B)(6) 2022, THE PATIENT UNDERWENT A REINTERVENTION. ANGIOGRAPHY DURING THE REINTERVENTION DID NOT SHOW A TYPE IIIA ENDOLEAK, BUT TWO GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS / AORTIC EXTENDER ENDOPROSTHESIS (TWO CXA280005) AND ONE NON-GORE STENT GRAFT WERE IMPLANTED RE-LINING FROM THE TRUNK - IPSILATERAL LEG ENDOPROSTHESIS (CAPTURED IN ANOTHER REPORT, #3007284313-2022-02230) TO THE PROXIMAL NINE AORTIC EXTENDER ENDOPROSTHESIS (CAPTURED IN ANOTHER REPORT, #3007284313-2022-02230). THE PROCEDURE WAS COMPLETED AFTER CONFIRMING NO PROBLEMS BY ANGIOGRAPHY. ON AN UNKNOWN DATE IN 2024, DURING FOLLOW-UP EXAMINATION MORE THAN TWO YEARS AFTER THE PREVIOUS REINTERVENTION, SUSPECTED TYPE IIIA ENDOLEAK(S) WAS FOUND AND A SECOND REINTERVENTION WAS PERFORMED. DURING TH

  Patient problems: Clinical Endoleak

  MAUDE report 21165024 ↗
• MalfunctionDec 11, 2024Break; Break

  ON (B)(6) 2024, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS. AFTER THE AORTIC EXTENDER COMPONENT WAS DEPLOYED, IT WAS OBSERVED THAT THE DISTAL SIDE OF THE DEVICE GOT TURNED UP. THE WRINKLES WERE IMPROVED WITH TOUCH-UP BALLOONING, BUT THE TURNED UP WAS NOT IMPROVED. A CONE BEAM COMPUTED TOMOGRAPHY(CBCT) WAS PERFORMED TO BE SURE, AND ALTHOUGH WRINKLES WERE OBSERVED IN THE TURNED-UP AREA, THE PHYSICIAN DETERMINED THAT IT WILL BE NO PROBLEM, AND THE PROCEDURE WAS COMPLETED. THE PATIENT TOLERATED THE PROCEDURE. THE PHYSICIAN REPORTED THAT THE DEVICE WAS DEPLOYED TOO SLOWLY, WHICH MIGHT HAVE CAUSED THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20900147 ↗
• InjurySep 13, 2024Malposition of Device; Malposition of Device

  ON (B)(6) 2024, THIS PATIENT UNDERWENT AN ENDOVASCULAR TREATMENT FOR INFRARENAL AORTIC PSEUDOANEURYSM (JUST DISTAL THE RIGHT RENAL ARTERY) USING AN AORTIC EXTENDER COMPONENT OF GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS WITH ACTIVE CONTROL SYSTEM. AFTER IMPLANTING A BARE-METAL STENT IN THE LEFT RENAL ARTERY (CHIMNEY TECHNIQUE), (B)(6) WAS SLOWLY DEPLOYED JUST DISTAL THE RIGHT RENAL ARTERY; HOWEVER, IT MOVED PROXIMALLY AND THE RIGHT RENAL ARTERY WAS UNINTENTIONALLY COVERED FOR APPROXIMATELY 90%. AN ADDITIONAL BARE-METAL STENT WAS PLACED IN THE RIGHT RENAL ARTERY. ALSO, AN ADDITIONAL GORE® VIABAHN® ENDOPROSTHESIS WAS DEPLOYED TO EXTEND THE LEFT CHIMNEY. TRIPLE KISSING BALLOONING WAS PERFORMED, AND NO ENDOLEAK WAS FOUND BY THE FINAL ANGIOGRAPHY. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Obstruction/Occlusion

  MAUDE report 20209242 ↗
• InjuryAug 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2024, THE PATIENT UNDERWENT AN ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS AND GORE® EXCLUDER®AAA ENDOPROSTHESES. A GORE® MOLDING & OCCLUSION BALLOON CATHETER (MOB) WAS USED AS ACCESSORY IN THE PROCEDURE. AFTER DEPLOYMENT OF TRUNK-IPSILATERAL LEG ENDOPROSTHESIS, THE DEVICE MIGRATED DISTALLY AT THE OUTER CURVATURE OF THE AORTA DURING BALLOON TOUCH-UP. AN AORTIC EXTENDER ENDOPROSTHESES WAS ADDITIONALLY IMPLANTED TO THE MOST PROXIMAL SIDE, AND AFTER BALLOON TOUCH-UP, THE PROCEDURE WAS COMPLETED. ON AN UNKNOWN DATE IN (B)(6) 2024, AT ONE-MONTH FOLLOW UP EXAMINATION, THE PATIENT COMPLAINED OF BACK PAIN. A CT SCAN CONFIRMED A TYPE B AORTIC DISSECTION. THE ENTRY OF DISSECTION WAS AT THE SUPERIOR MESENTERIC ARTERY LEVEL AND IT EXTENDED TO THE LEFT RENAL ARTERY. THE PATIENT WAS DECIDED TO BE MONITORED WITH BLOOD PRESSURE CONTROL (MEDICATION). REPORTEDLY IT WAS POSSIBLE THAT THE DISSECTION OCCURRED DURING BALLOON TOUCH-UP OF THE AORTIC EXTENDER, BUT THE PHYSICIAN MENTIONED THE BALLOON WAS NOT OVER INFLATED NOR STRONGLY TOUCH-UP. HE ALSO MENTIONED THE PATIENT AORTA MAY BE FRAGILE. AFTER REVIEWING THE FINAL ANGIOGRAPHY

  Patient problems: Vascular Dissection

  MAUDE report 19946958 ↗
• MalfunctionMay 23, 2024Material Deformation; Material Deformation

  ON (B)(6) 2024, THIS PATIENT UNDERWENT AN ENDOVASCULAR TREATMENT FOR ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESIS AND GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS WITH ACTIVE CONTROL SYSTEM. IN THE PROXIMAL SIDE, CXT281412, CXA280005, AND PLA280300J WERE DEPLOYED. AFTER DEPLOYING THE PLA280300J, A FOREIGN OBJECT THAT SEEMED TO BE A DETACHED STENT WIRE WAS NOTED JUST DISTAL THE PLA280300J BY FLUOROSCOPIC IMAGING. NO FURTHER TREATMENT WAS GIVEN AND THE PROCEDURE WAS CONCLUDED. THE PATIENT TOLERATED THE PROCEDURE. NO INJURY TO THE PATIENT WAS REPORTED. THE REPORTING PHYSICIAN COMMENTED AS FOLLOWS: THE FOREIGN OBJECT APPEARED SUDDENLY AFTER DEPLOYING THE PLA280300J. IT APPEARED TO BE CLEARLY INTERFERING WITH THE BALLOON CATHETER AND THUS, IT WAS CONSIDERED TO BE INSIDE THE DEVICE. ON (B)(6) 2024, A FOLLOW-UP CT SCAN SHOWED THAT THE DISTAL STENT WIRE OF THE CXA280005 WAS DEFORMED (FOLDED INWARD). THEREFORE, THE PHYSICIAN CONCLUDED THAT SOME CATHETER CAUGHT THE STENT WIRE OF CXA280005 AND DEFORMED IT DUE TO CATHETER HANDLING AFTER DEPLOYMENT. NO TREATMENT WAS PLANNED AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19379051 ↗
• MalfunctionApr 19, 2024Activation Failure; Activation Failure

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2024, THIS PATIENT UNDERWENT AN ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS WITH ACTIVE CONTROL SYSTEM. DURING THE DEPLOYMENT OF AN AORTIC EXTENDER ENDOPROSTHESIS(CXA280005), THE DISTAL END OF DEVICE INFOLDED AND ONE OF DISTAL ANCHORS WAS POSITIONED VERTICALLY AGAINST THE LEFT SIDE OF THE VESSEL WALL. THE PHYSICIAN PERFORMED A BALLOONING WITHIN THE EXPANDED CXA280005 WHICH SUCCESSFULLY RESTORED THE SHAPE OF THE DEVICE. NO ADVERSE EFFECTS TO PATIENT WERE REPORTED. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19141608 ↗
• InjuryDec 7, 2023Adverse 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) 2023, THIS PATIENT UNDERWENT AN ENDOVASCULAR TREATMENT USING GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS AND GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS FOR ABDOMINAL AORTIC ANEURYSM AND A RIGHT COMMON ILIAC ARTERY ANEURYSM. AN AORTIC EXTENDER ENDOPROSTHESIS WAS DEPLOYED TO REINFORCE PROXIMAL SEALING. REPORTEDLY, GORE® MOLDING & OCCLUSION BALLOON WAS USED FOR THE PROXIMAL TOUCH-UP. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2023, CONTRAST-ENHANCED COMPUTED TOMOGRAPHY SCAN WAS PERFORMED. RETROGRADE AORTIC DISSECTION WAS CONFIRMED NEAR THE PROXIMAL END OF THE AORTIC EXTENDER ENDOPROSTHESIS. ALTHOUGH THE EXTENT OF THE DISSECTION COULD NOT BE CONFIRMED, IT WAS SUGGESTED THAT IT MAY HAVE EXTENDED TO THE DESCENDING AORTA. THE PHYSICIAN STATED AS FOLLOWS: THIS MIGHT BE BECAUSE PROXIMAL TOUCH-UP WAS PERFORMED MORE THAN USUAL FOR SEALING.

  Patient problems: Vascular Dissection

  MAUDE report 18280694 ↗
• MalfunctionOct 17, 2023Positioning Failure; Positioning Failure

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2023, THE PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA) UTILIZING A GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS. REPORTEDLY, THE CONFORMABLE AORTIC EXTENDER DEPLOYED SIDEWAYS, THERE WERE NO ISSUES WITH DEPLOYMENT ITSELF AS IT WAS DEPLOYED VERY FAST, POSITIONED WELL AND ANGULATION WAS USED ON IT BUT THE DEVICE INFOLDED ON ITSELF. PHYSICIAN WAS ABLE TO BALLOON IT ENOUGH TO GET ANOTHER AORTIC EXTENDER (PLA) AND RECUFF IT. THERE WAS NO OBSTRUCTION BUT POSITIONING WAS BAD (POSITIONING UP TO DEPLOYMENT LOOKED FINE) AS THERE WAS LITTLE ANGULATION IN THE AORTIC NECK (THE MARKERS LOOKED FINE AND APPEARED TO BE WHERE THEY SHOULD HAVE BEEN, UNTIL DEPLOYMENT) WITH STABILIZATION BY A SECOND PAIR OF HANDS AND CALCIFICATION IN THE ILIAC BUT NOT WHERE DEVICE WAS DEPLOYED. PATIENT IS DOING OKAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17949785 ↗
• InjurySep 30, 2023Partial Blockage; Migration; Partial Blockage; Migration

  ON (B)(6) 2023, THE PATIENT UNDERWENT AN ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESES AND A GORE® EXCLUDER® AAA ENDOPROSTHESIS. WHILE ADDING THE AORTIC EXTENDER ENDOPROSTHESIS TO THE PROXIMAL END OF THE TRUNK - IPSILATERAL LEG ENDOPROSTHESIS, IT MOVED PROXIMALLY, AND THE RIGHT RENAL ARTERY WAS PARTIALLY COVERED. A BARE METAL STENT WAS PLACED TO THE RIGHT RENAL ARTERY USING A CHIMNEY TECHNIQUE, AND THE PROCEDURE WAS COMPLETED. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Aneurysm

  MAUDE report 17849308 ↗
• InjurySep 5, 2023Migration; Migration

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6)2023, THIS PATIENT UNDERWENT AN ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS. ANGIOGRAPHY PERFORMED DURING THE PROCEDURE REVEALED A PROXIMAL TYPE I ENDOLEAK WITH THE TRUNK-IPSILATERAL LEG ENDOPROSTHESIS. FOR REPAIR, AN AORTIC EXTENDER ENDOPROSTHESIS WAS DEPLOYED FROM JUST BELOW THE RENAL ARTERY, HOWEVER, THE AORTIC EXTENDER ENDOPROSTHESIS MOVED (JUMPED) 5 MM PROXIMALLY AND COVERED THE RIGHT RENAL ARTERY BY ABOUT 2/3. A STENT (EXPRESS¿ VASCULAR SD, BOSTON SCIENTIFIC) WAS IMPLANTED IN THE RIGHT RENAL ARTERY, AND RETENTION OF BLOOD FLOW WAS CONFIRMED BY ANGIOGRAPHY. FINAL ANGIOGRAPHY REVEALED A PROXIMAL TYPE I ENDOLEAK THAT STOPPED IN THE NECK AND A TYPE II ENDOLEAK, BUT THE ENDOLEAKS WERE NOT TREATED AND THE PROCEDURE WAS COMPLETED. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Obstruction/Occlusion

  MAUDE report 17686790 ↗
• InjuryAug 23, 2023Inadequacy of Device Shape and/or Size; Migration; Inadequacy of Device Shape and/or Size; Migration

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6), 2023, THE PATIENT UNDERWENT A SEMI-EMERGENCY ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESES AND GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS. AFTER TRUNK IPSILATERAL LEG ENDOPROSTHESIS (RLT281418J) WAS PLACED, TWO AORTIC EXTENDER COMPONENTS (CXA280005, PLA280300J) WERE ADDED TO THE PROXIMAL SIDE. WHEN BALLOONING WAS PERFORMED, THESE THREE IMPLANTED DEVICES MOVED DISTALLY AND FELL INTO THE ANEURYSM. ANOTHER AORTIC EXTENDER COMPONENT (PLA320400J) WAS IMPLANTED INTO THE PROXIMAL SIDE. AFTER THE PLACEMENT, A PROXIMAL TYPE I ENDOLEAK WAS CONFIRMED. IN ADDITION, TYPE III ENDOLEAKS WERE SUSPECTED FROM THE OVERLAP SITES OF PLA320400J AND CXA280005, CXA280005 AND RLT281418J. THE PROCEDURE WAS COMPLETED THIS TIME, BUT REINTERVENTION WILL BE PERFORMED AT A LATER DATE. REPORTEDLY SNORKEL EVAR OR AUI IS CONSIDERED. THE PHYSICIAN'S COMMENT: THE PATIENT HAD SEVERE PROXIMAL NECK ANGULATION WITH CONICAL NECK SHAPE OF NECK DIAMETER OF 18-24 MM. THIS CASE MAY NOT ANATOMICALLY APPLICABLE FOR EVAR.

  Patient problems: Clinical Endoleak

  MAUDE report 17605325 ↗
• InjuryJul 6, 2023Malposition of Device; Malposition of Device

  ON (B)(6) 2019, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF A ZONE 9 INFRARENAL ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESES. ON (B)(6) 2023, THE PATIENT UNDERWENT REINTERVENTION FOR AORTIC NECK DEGENERATION AND ANEURYSM SAC ENLARGEMENT (AMOUNT UNKNOWN) WITH NO EVIDENCE OF A TYPE I ENDOLEAK. A GORE® EXCLUDER® CONFORMABLE AORTIC EXTENDER COMPONENT (CXA) WAS USED TO EXTEND THE PREVIOUSLY IMPLANTED TRUNK-IPSILATERAL LEG COMPONENT PROXIMALLY. UPON INITIATION OF CXA DEVICE DEPLOYMENT, THE DEVICE WAS REPORTEDLY DEPLOYED SLOWLY IN AN ATTEMPT TO ENSURE ACCURATE DEVICE PLACEMENT. HOWEVER, DUE TO THE SLOW RATE OF DEPLOYMENT, ONCE THE DISTAL (TRAILING) STENT ROWS WERE RELEASED, STENT FLIP OCCURRED WHERE THE DISTAL STENT ROWS OF THE DEVICE FLOWERED OUT AND BECAME LODGED AGAINST THE AORTIC WALL. REPORTEDLY, AFTER THE PROXIMAL (LEADING) END OF THE DEVICE WAS DEPLOYED AT A SLIGHTLY INCREASED RATE OF SPEED, THE CXA HAD BEEN INADVERTENTLY PLACED TOO HIGH RESULTING IN AN ACCESSORY RENAL ARTERY BEING FULLY COVERED AND THE PATIENT'S RIGHT RENAL ARTERY BEING PARTIALLY COVERED. ICAST STENTS WERE USED FOR RENAL STENTING. THERE WERE NO ISSUES OBSERVED AT THE CLOSE OF THE PROCEDUR

  Patient problems: Obstruction/Occlusion

  MAUDE report 17270167 ↗
• InjuryFeb 1, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2022, THE PATIENT UNDERWENT AN EMERGENCY ENDOVASCULAR TREATMENT OF A THORACOABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESES. ON (B)(6) 2023, IT WAS CONFIRMED A TYPE IIIA ENDOLEAK. REPORTEDLY THREE DEVICES WERE IMPLANTED ON (B)(6), BUT IT WAS NOT DETERMINED WHICH DEVICES ARE RELATED TO THE EVENT, TYPE IIIA ENDOLEAK. A REINTERVENTION FOR ADDING STENT GRAFTS WAS PLANNED ON (B)(6) 2023. THERE IS NO DETAILED INFORMATION REGARDING THE REINTERVENTION.

  Patient problems: Clinical Endoleak

  MAUDE report 16280057 ↗
• InjuryDec 13, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  ON (B)(6) 2022, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS AND GORE® EXCLUDER® AAA ENDOPROSTHESIS. AFTER ALL STENT GRAFTS WERE IMPLANTED, INTRA-OPERATIVE IMAGING REPORTEDLY REVEALED A PROXIMAL TYPE I ENDOLEAK. TOUCH-UP BALLOONING WAS REPEATED, HOWEVER, THE ENDOLEAK WAS NOT RESOLVED. AN AORTIC EXTENDER ENDOPROSTHESIS (GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS) WAS IMPLANTED PROXIMALLY TO TREAT THE TYPE IA ENDOLEAK. ACCORDING TO THE REPORT, THE AORTIC EXTENDER ENDOPROSTHESIS PARTIALLY AND UNINTENTIONALLY COVERED THE LEFT RENAL ARTERY. AS THE BLOOD FLOW OF THE LEFT RENAL ARTERY WAS NOT DELAYED, IT WAS DECIDED NO ADDITIONAL TREATMENT WAS REQUIRED. THE ENDOLEAK WAS RESOLVED, AND THE PROCEDURE WAS CONCLUDED WITHOUT ANY FURTHER REPORTED COMPLICATIONS.

  Patient problems: Obstruction/Occlusion

  MAUDE report 15973774 ↗