GORE EXCLUDER Conf AAA Endo - Aortic ExtenderRecalls & reported problems across all models

We found 6 models of GORE EXCLUDER Conf AAA Endo - Aortic Extender by W. L. Gore & Associates, Inc. in the FDA's device registry (GUDID). Together they are named in 98 adverse event reports in the FDA's MAUDE database, received between Aug 4, 2021 and Aug 4, 2026 — classified as 7 deaths, 78 injuries, 13 malfunctions.

The most frequently reported specific device problem is “Malposition of Device” (17 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported GORE EXCLUDER Conf AAA Endo - Aortic Extender problems

GORE EXCLUDER Conf AAA Endo - Aortic Extender models

6 models, most reported first. Each model has its own page with its reports, recalls and device details.

• GORE EXCLUDER Conf AAA Endo - Aortic Extender CXA360005

  System, Endovascular Graft, Aortic Aneurysm Treatment
  2 deaths23 reports
• GORE EXCLUDER Conf AAA Endo - Aortic Extender CXA280005

  System, Endovascular Graft, Aortic Aneurysm Treatment
  1 death22 reports
• GORE EXCLUDER Conf AAA Endo - Aortic Extender CXA230005

  System, Endovascular Graft, Aortic Aneurysm Treatment
  2 deaths20 reports
• GORE EXCLUDER Conf AAA Endo - Aortic Extender CXA260005

  System, Endovascular Graft, Aortic Aneurysm Treatment
  1 death15 reports
• GORE EXCLUDER Conf AAA Endo - Aortic Extender CXA200005

  System, Endovascular Graft, Aortic Aneurysm Treatment
  1 death9 reports
• GORE EXCLUDER Conf AAA Endo - Aortic Extender CXA320005

  System, Endovascular Graft, Aortic Aneurysm Treatment
  9 reports

Recent GORE EXCLUDER Conf AAA Endo - Aortic Extender adverse event reports

The 15 most recent reports across all models, 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• InjuryApr 13, 2026Malposition of Device

  IT WAS REPORTED TO GORE THAT ON (B)(6) 2026, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM USING THE GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESES. DURING DEPLOYMENT OF THE AORTIC EXTENDER, THE LEFT RENAL ARTERY WAS UNINTENTIONALLY COVERED BY APPROXIMATELY THREE-QUARTERS, RESULTING IN NEAR LOSS OF BLOOD FLOW. A BARE METAL STENT WAS ADDITIONALLY IMPLANTED IN THE LEFT RENAL AS TREATMENT, LEADING TO IMPROVED BLOOD FLOW. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Obstruction/Occlusion

  MAUDE report 24867454 ↗
• 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 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗

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