BEUDAMED
    FDA Adverse Event Death Summary report: N

    MIZUHO AMERICA, INC. ANEURYSM CLIP

    MDR report key: 1571709 · Received January 4, 2010

    Report

    Report Number
    1571709
    Event Type
    Death
    Date Received
    January 4, 2010
    Date of Event
    October 24, 2009
    Report Date
    October 31, 2009
    Manufacturer
    MIZUHO AMERICA, INC.
    Product Code
    HCH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT S/P ANEURYSM CLIPPING. LETHARGIC POSTOPERATIVELY, HOWEVER, APPEARED TO BE RECOVERING APPROPRIATELY. SUBSEQUENT MENTAL STATUS DECLINE. STAT CT WAS DONE WHICH WAS NOTED TO HAVE A SUBDURAL COLLECTION. TAKEN TO THE OR EMERGENTLY FOR AN EVACUATION; CLOT WAS EVACUATED. POSTOPERATIVELY, A FOLLOW-UP CT SCAN WAS DONE WHICH WAS NOTED FOR A HYPODENSITY WHICH WAS CONSISTENT WITH STROKE BEING CAUSE OF PT'S MENTAL STATUS DECLINE AND LESS THE SUBDURAL COLLECTION. NEUROSURGEON NOTED ON CT SCAN THAT ANEURYSM CLIP HAD SLIPPED/CHANGED POSITION AS CAUSE OF STROKE. MFR NOTIFIED BY OR PERSONNEL. PRODUCT NO LONGER BEING USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MIZUHO AMERICA, INC. ANEURYSM CLIP ANEURYSM CLIP HCH MIZUHO AMERICA, INC. 940-90
    2 MIZUHO AMERICA, INC. ANEURYSM CLIP ANEURYSM CLIP HCH MIZUHO AMERICA, INC. 940-91
    3 MIZUHO AMERICA, INC. ANEURYSM CLIP ANEURYSM CLIP HCH MIZUHO AMERICA, INC. 940-92
    4 MIZUHO AMERICA, INC. ANEURYSM CLIP ANEURYSM CLIP HCH MIZUHO AMERICA, INC. 19A-C

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Death| L| O