BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNKMICRUSFRAME

    MDR report key: 8170720 · Received December 17, 2018

    Report

    Report Number
    3008114965-2018-00828
    Event Type
    Death
    Date Received
    December 17, 2018
    Date of Event
    March 31, 2015
    Report Date
    November 28, 2018
    Manufacturer
    SEE H.10
    Product Code
    KRD
    PMA / PMN Number
    K150319
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO DEVICE WAS RECEIVED FOR ANALYSIS AT THE TIME OF SUBMISSION OF THE INITIAL 3500A. SINCE THE PRODUCT WAS NOT RETURNED FOR ANALYSIS, NO PRODUCT FAILURE ANALYSIS CAN BE CONDUCTED AND NO DETERMINATION OF POSSIBLE CONTRIBUTING FACTORS COULD BE MADE. DEVICE HISTORY RECORD (DHR) REVIEW CANNOT BE CONDUCTED BECAUSE THE NO LOT NUMBER WAS PROVIDED BY THE CUSTOMER. PRODUCT COMPLAINT #: (B)(4). PHYSICAL MANUFACTURER NAME: CODMAN AND SHURTLEFF INC., DBA DEPUY SYNTHES PRODUCTS, INC. ((B)(4)).

    Description of Event or Problem · 1

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. AS REPORTED IN THE LITERATURE PUBLICATION ENTITLED, ¿EXPANDING ENDOVASCULAR THERAPY OF VERY SMALL RUPTURED ANEURYSMS WITH THE 1.5-MM COIL.¿ A (B)(6) FEMALE PATIENT WITH AN ANTERIOR COMMUNICATING ARTERY ANEURYSM WHO UNDERWENT BALLOON ASSISTED COIL EMBOLIZATION DIED DUE TO VENTRICULITIS. IN THIS STUDY, THE CLINICAL AND ANGIOGRAPHIC OUTCOME OF PATIENTS WITH VERY SMALL RUPTURED ANEURYSMS TREATED WITH THE 1.5-MM COIL WERE REVIEWED. METHODS: THIS IS A RETROSPECTIVE COHORT STUDY IN WHICH WE EXAMINED CONSECUTIVE RUPTURED VERY SMALL ANEURYSMS TREATED WITH COIL EMBOLIZATION AT A SINGLE INSTITUTION. THE LONGEST LINEAR ANEURYSM WAS RECORDED, EVEN IF THE FIRST COIL WAS SIZED TO A SMALLER TRANSVERSE DIAMETER. VERY SMALL ANEURYSMS WERE DEFINED AS = 3 MM. FROM JULY 2007 TO MARCH 2015, 5 PATIENTS WITH 3-MM ANEURYSMS WERE TREATED ACUTELY WITH COILS. IN ALL 5 PATIENTS, A BALLOON WAS PLACED FOR HEMOSTATIC PROPHYLAXIS IN CASE OF RUPTURE, AND A SINGLE 1.5-MM COIL WAS INSERTED FOR ANEURYSM TREATMENT

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1011648 UNKMICRUSFRAME MICRUSFRAME KRD SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Death