BEUDAMED
    FDA Adverse Event Death Summary report: N

    COOK Z-FEN ENDOGRAFT STENT

    MDR report key: 19013612 · Received March 29, 2024

    Report

    Report Number
    MW5153430
    Event Type
    Death
    Date Received
    March 29, 2024
    Date of Event
    March 26, 2024
    Report Date
    March 27, 2024
    Manufacturer
    COOK MEDICAL LLC.
    Product Code
    MIH
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    GA, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PER THE VASCULAR SURGEON'S OP NOTE: INFRARENAL ABDOMINAL AORTIC ANEURYSM RUPTURE, IN THE SETTING OF PRIOR COOK Z-FEN ENDOGRAFT REPAIR IN 2019 AT OUTSIDE HOSPITAL. INTRAOPERATIVE FINDINGS WERE CONSISTENT WITH A TYPE III ENDOLEAK-ENDOGRAFT COMPONENT SEPARATION - LIKELY CAUSING THE SAC EXPANSION AND EVENTUAL RUPTURE. THE PT EXPIRED ON (B)(6) 2024.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1567536 COOK Z-FEN ENDOGRAFT STENT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH COOK MEDICAL LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Male Death| L