GORE EXCLUDER Conf AAA Endo - Trunk-Ipsilateral CXT201212Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00733132650989), received between Jul 6, 2021 and Apr 2, 2026 — classified as 1 death, 5 injuries.

The most frequently reported specific device problem is “Deformation Due to Compressive Stress” (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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryApr 2, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT THE DEVICES WERE EXPLANTED DUE TO LIMB OCCLUSION, THE PATIENT PRESENTED WITH ISCHEMIA OF LOWER LIMB.

  Patient problems: Insufficient Information

  MAUDE report 24771888 ↗
• InjurySep 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2022, THE PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA) UTILIZING GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS (TRUNK IPSILATERAL LEG CONFORMABLE) AND GORE® EXCLUDER® AAA ENDOPROSTHESIS (CONTRALATERAL LEG AND ILIAC EXTENDER). ON (B)(6) 2024, PATIENT PRESENTED FOR A YEARLY FOLLOW UP AFTER THE INITIAL PROCEDURE WHERE PATIENT UNDERWENT AN ABDOMINAL ULTRASOUND THAT SHOWED THE AAA HAD INCREASED IN SIZE TO 4.6 X 4.1CM FROM 4.3 X 3.8CM IN 2023 (DATE UNKNOWN). THE PATIENT IS REPORTEDLY DOING WELL WITH NO REPORTED COMPLAINTS OF ABDOMINAL OR BACK PAIN AND NO CLAUDICATION. ON (B)(6) 2025, THE PATIENT UNDERWENT AN ENDOVASCULAR REINTERVENTION PROCEDURE TO TREAT AN EXPANDING ANEURYSM (55MM) UTILIZING A GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS (AORTIC CONFORMABLE EXTENDER). REPORTEDLY, DUE TO THE PATIENT'S EXPANDING ANEURYSM (CAUSE IS UNKNOWN) WITH NO CLEAR EVIDENCE OF ENDOLEAK, PHYSICIAN DECIDED TO DO AN ELECTIVE PROCEDURE AS A PRECAUTION BY EXTENDING PROXIMALLY WITH AN AORTIC CONFORMABLE EXTENDER FROM THE TRUNK IPSILATERAL LEG CONFORMABLE. PATIENT TOLERATED THE PROCEDURE. 1001-E: -UNKNOWN IS USED TO

  Patient problems: Aneurysm expansion

  MAUDE report 22992644 ↗
• InjuryOct 9, 2024Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  ON (B)(6) 2024, PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE TO TREAT A ABDOMINAL AORTIC ANEURYSM, UTILIZING GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS. ON (B)(6) 2024, DURING A FOLLOW-UP VISIT, AN ULTRASOUND WAS PERFORMED WHICH SHOWED INCREASED VELOCITIES IN LEFT LEG. A CT WAS ALSO PERFORMED, AND IT SHOWED PATIENT'S LEFT ILIAC LIMB WAS COMPRESSED, NEAR THE AORTIC BIFURCATION. PHYSICIAN RECOMMENDED A REINTERVENTION SURGERY TO TREAT THIS COMPRESSION. ON (B)(6) 2024, PATIENT UNDERWENT A REINTERVENTION SURGERY TO TREAT THIS COMPRESSION. PHYSICIAN BALLOONED THE AREA WITH 8MMX40MM BALLOON AND THEN A 10MMX40MM BALLOON. PHYSICIAN WAS SATISFIED WITH RESULTS, AND STATED HE MUST'VE NOT BALLOONED THIS AREA ENOUGH IN THE INITIAL CASE. PATIENT TOLERATED THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20408293 ↗
• InjuryMay 24, 2022Obstruction of Flow; Obstruction of Flow

  ON (B)(6) 2022, THE PATIENT WAS ADMITTED FOR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM AND WAS IMPLANTED WITH A GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS TRUNK IPSILATERAL COMPONENT AND A GORE® EXCLUDER® AAA ENDOPROSTHESIS CONTRALATERAL LEG COMPONENT. OVER THE FOLLOWING WEEKEND THE PATIENT WENT TO THE EMERGENCY ROOM, AND IT WAS IDENTIFIED THAT THERE WAS AN OCCLUDED LIMB. A REINTERVENTION WAS PERFORMED ON (B)(6) 2022. THE REINTERVENTION INVOLVED A THROMBECTOMY FOLLOWED BY THE IMPLANTATION OF TWO GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESES AT THE AORTIC BIFURCATION VIA KISSING BALLOON TECHNIQUE IN ORDER TO PRESERVE BLOOD FLOW. AS REPORTED, THE OCCLUSION OCCURRED ON THE IPSILATERAL SIDE. THE CAUSE FOR THE NEEDED REINTERVENTION WAS DIRECTLY IDENTIFIED AS THE PATIENT ANATOMY THAT NARROWED GREATLY AROUND THE BIFURCATION. AS REPORTED THE FLOW DIVIDER WAS LATER OBSERVED TO HAVE LANDED DIRECTLY IN THE RESTRICTED AREA OF THE PATIENT¿S ANATOMY. AS REPORTED, THERE WAS NO MORE THAN APPROXIMATELY 1CM TO A 1/2CM OF SPACE IN ONE SPOT. IT WAS INDICATED THAT FOLLOWING THE INITIAL TREATMENT PROCEDURE ON (B)(6) 2022, THAT THE POST-IMPLANTATION IMAGING CONDUCTED SHOWED THAT ALL VESSELS WE

  Patient problems: Obstruction/Occlusion

  MAUDE report 14488357 ↗
• DeathAug 17, 2021Use of Device Problem; Use of Device Problem

  ON (B)(6) 2021, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AORTIC OCCLUSIVE DISEASE AND WAS IMPLANTED WITH GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESES. THE TRUNK IPSILATERAL LEG COMPONENT DEPLOYED CORRECTLY BUT WAS POSITIONED SLIGHTLY HIGHER THAN INTENDED WITH PARTIAL COVERAGE OF THE OSTIUM OF A RENAL ARTERY. THE DEVICE WAS RECONSTRAINED AND THE PHYSICIAN ATTEMPTED TO REPOSITION BUT STRUGGLED WITH TRYING TO REPOSITION THE CXT AND CHOSE TO LEAVE IT AS IS AND IMPLANT A GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX) COVERED STENT IN ONE OF THE RENAL ARTERIES TO ENSURE GOOD FLOW. DURING POST-DILITATION OF THE VBX WITH A CODA BALLOON CATHETER THE RENAL ARTERY WAS RUPTURED DUE TO BELIEVED OVER-INFLATION OF THE BALLOON. THE PATENT EXPIRED INTRA-PROCEDURE, A CAUSE OF DEATH WAS NOT PROVIDED.

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

  MAUDE report 12334625 ↗
• InjuryJul 6, 2021Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  ON (B)(6) 2021 THE PATIENT UNDERWENT EMERGENT ENDOVASCULAR TREATMENT OF A RUPTURED ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESES. THERE WERE NO REPORTED ISSUES. ON (B)(6) 2021 IT WAS REPORTED BY THE PHYSICIAN THAT, DURING THE ONE MONTH FOLLOW-UP ON AN UNKNOWN DATE, CT IMAGING WAS PERFORMED AND POTENTIAL DEVICE OCCLUSION WAS OBSERVED. THE CAUSE OF THE SUSPECTED DEVICE OCCLUSION WAS UNKNOWN. ON (B)(6) 2021 A REINTERVENTION WAS PERFORMED. IT WAS REPORTED THAT A SLIGHT KINK ON THE IPSILATERAL LEG OF THE TRUNK-IPSILATERAL LEG COMPONENT WAS CONFIRMED. THE IPSILATERAL LIMB WAS LOCATED ON THE PATIENT'S RIGHT SIDE. REPORTEDLY THERE WAS NO DEVICE OCCLUSION, AND DISTAL BLOOD FLOW WAS PRESENT. IT WAS REPORTED THAT THE IPSILATERAL LIMB WAS SLIGHTLY PINCHED/KINKED DUE TO PATIENT ANATOMY. REPORTEDLY THE PATIENT'S AORTA MEASURED 15MM IN DIAMETER AND HAD A LARGE ANGLE. DUE TO THE PATIENT'S ANATOMY, THE IPSILATERAL LEG OF THE TRUNK-IPSILATERAL LEG COMPONENT WAS LANDED ON THE INNER CURVE OF THE PATIENT'S AORTA, THUS CAUSING A SLIGHT KINK. THERE WERE NO PATIENT ADVERSE EVENTS NOTED IN RELATION TO THE KINKED IPSILATERAL LIMB. A GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12125098 ↗