BEUDAMED
    FDA Adverse Event Death Summary report: N

    GORE® EXCLUDER® AAA ENDOPROSTHESIS

    MDR report key: 21883810 · Received April 22, 2025

    Report

    Report Number
    3007284313-2025-03919
    Event Type
    Death
    Date Received
    April 22, 2025
    Date of Event
    November 18, 2024
    Report Date
    May 8, 2025
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    MIH
    UDI-DI
    00733132622375
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AS IT IS UNKNOWN WHICH DEVICE(S) IS DIRECTLY IMPLICATED IN THIS DEATH EVENT, THE FOLLOWING DEVICE(S) WILL ALSO BE INCLUDED IN THIS REPORT: CATALOG #PLC141200/ SERIAL # (B)(6)/ UDI #(B)(4). CATALOG #PLC141000/ SERIAL # (B)(6)/ UDI #(B)(4). ACCORDING TO THE GORE® EXCLUDER® AAA ENDOPROSTHESIS INSTRUCTIONS FOR USE, ADVERSE EVENTS THAT MAY OCCUR AND / OR REQUIRE INTERVENTION INCLUDE DEATH, ARTERIAL OR VENOUS THROMBOSIS, OCCLUSION OF DEVICE OR NATIVE VESSEL, SINGLE OR MULTIPLE VESSELS. W. L. GORE & ASSOCIATES, INC. (GORE) IS SUBMITTING THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY GORE, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. BLANK FIELDS PRESENT ON THIS REPORT INCLUDE REQUIRED FIELDS AND FIELDS DETERMINED TO BE NOT APPLICABLE. BLANK REQUIRED FIELDS INDICATE THAT THE INFORMATION WAS NOT PROVIDED, WAS DEEMED UNAVAILABLE OR WAS NOT APPLICABLE. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, GORE, OR ITS ASSOCIATES THAT THE DEVICE, GORE OR ITS ASSOCIATES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE A LEGAL ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY DEFECTS OR HAS MALFUNCTIONED, AS DEFINED FROM A LEGAL STANDPOINT. THESE WORDS ARE INCLUDED IN THE REPORT AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA, TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REPORTING PURSUANT TO PART 803. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT.

    Additional Manufacturer Narrative · 0

    ADDED G3/G4, H1/H2, H6.

    Description of Event or Problem · 0

    THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2024, THE PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE UTILIZING THE GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE) AND GORE® EXCLUDER® AAA ENDOPROSTHESIS (RLT AND 2 PLCS) IN ZONE 5. PRIOR TO THE PROCEDURE, THE PHYSICIAN ADDRESSED THE PATIENT'S LEFT RENAL ARTERY THAT WAS ALREADY OCCLUDED. A GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICE/STENT) WAS DEPLOYED INTO THE RENAL PORTAL THAT WAS FOLLOWED BY AN AMPLATZER PLUG. DURING THE PROCEDURE, THERE WAS NOT AN ADEQUATE LANDING ZONE IN THE PATIENT¿S CELIAC ARTERY. THERE WAS A SHORT BRANCH FROM THE LEFT GASTRIC ARTERY THAT BRANCHED OFF THE SPLENIC ARTERY. TO ACHIEVE A SEAL INTO THE CELIAC ARTERY, THE PHYSICIAN PLUGGED THE SPLENIC ARTERY AND COILED THE LEFT GASTRIC ARTERY. A VBX DEVICE WAS THEN IMPLANTED INTO THE PATIENT¿S HEPATIC ARTERY. ADDITIONAL VBX DEVICES WERE IMPLANTED IN THE CELIAC ARTERY AND SUPERIOR MESENTERIC ARTERY WITH NO ISSUES. ON (B)(6) I-CAST STENT WAS IMPLANTED IN THE RIGHT RENAL ARTERY (RRA) DUE TO EXISTING HIGH-GRADE STENOSIS. DURING THE PROCEDURE, TWO VBX DEVICES WERE DEPLOYED WITHIN THE RRA. AS REPORTED, PROCEDURE WENT SMOOTHLY AND THE PATIENT TOLERATED THE PROCEDURE. AFTER PROCEDURE COMPLETION, A NON-CONTRAST CT IMAGING SHOWED ALL DEVICES WERE WIDELY PATENT WITH NO COMPRESSION OR STENOSIS NOTED. ON (B)(6) 2024, THE NURSING STAFF CHANGED THE PATIENT'S BEDDING AND THE PATIENT MOVED ON HER OWN WITH NO ISSUES. HOWEVER, WHEN THE PATIENT WAS MOVED BACK INTO BED, HER BLOOD PRESSURE DROPPED INTO THE 50¿S WHEN LYING FLAT IN BED. THE PATIENT CODED AND ADVANCED CARDIAC LIFE SUPPORT (ACLS) WAS PERFORMED. AFTER RESUSCITATION, THE PATIENT WAS INTUBATED, AND IT WAS ALSO NOTED THAT SHE HAD ASPIRATED. THE PATIENT WAS TRANSFERRED FOR CTA SCAN OF THE CHEST. ABDOMEN AND PELVIS SHOWED IRREGULAR RESPONSE OF AORTA SECONDARY TO CARDIAC DYSFUNCTION. THE PATIENT HAD RIB FRACTURES NOTED ON THE CT AFTER ACLS. THE VBX STENTS IN THE RIGHT RENAL ARTERY WERE ALSO CRUSHED. AS REPORTED, THE PHYSICIAN BELIEVES THAT DUE TO CARDIAC EVENT AND EXTENDED LOW / MINIMAL BLOOD PRESSURE, THE PATIENT'S VISCERAL ARTERIES (CELIAC, HEPATIC, SMA, AND RIGHT RENAL ARTERY) ALL PRESENTED AS THROMBOSED/OCCLUDED, ALONG WITH THE TAMBE DEVICE, VBX DEVICE, AND EXCLUDER DEVICES. THE PATIENT REMAINED INTUBATED POST CT SCAN AND EXPIRED SOMETIME IN THE MORNING. THE RIGHT RENAL ARTERY VBX STENTS WERE LIKELY CRUSHED WHILE TRYING TO RESUSCITATE THE PATIENT. THE PRIMARY CAUSE OF THE PATIENT'S DEATH IS UNKNOWN. IT IS ALSO UNKNOWN IF THE PATIENT HAD SENSITIVITY TO HEPARIN AS TESTING WAS NOT DONE PRIOR TO PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    627502 GORE® EXCLUDER® AAA ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W. L. GORE & ASSOCIATES, INC. 00733132622375

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Female Other| D