BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COIL-THERMO MECHANICAL

    MDR report key: 8165401 · Received December 14, 2018

    Report

    Report Number
    2954740-2018-00520
    Event Type
    Injury
    Date Received
    December 14, 2018
    Report Date
    November 25, 2018
    Manufacturer
    SEE H.10
    Product Code
    KRD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    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. (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, ¿INTERDISCIPLINARY TREATMENT SELECTION IN ADMITTED PATIENTS WITH ACUTE SUBARACHNOID HEMORRHAGE.¿ 2 PATIENTS WITH RUPTURED INTRACRANIAL ANEURYSM WHO UNDERWENT ENDOVASCULAR COIL EMBOLIZATION WITH ORBIT COILS, SUFFERED RECANALIZATION WHICH REQUIRED SURGICAL INTERVENTION. OBJECTIVE: TO REVIEW THE ANGIOGRAPHIC AND CLINICAL OUTCOMES FROM ACUTE (FIRST 6 HOURS AFTER BLEEDING) INTERDISCIPLINARY TREATED PATIENTS WITH RUPTURED INTRACRANIAL ANEURYSM. METHOD: AN INTERVENTIONAL NEURORADIOLOGIST AND A NEUROSURGEON SET THE EMERGENT TREATMENT OF 100 CONSECUTIVE PATIENTS WITH SUBARACHNOID HEMORRHAGE (SAH) HARBORING 111 CEREBRAL ANEURYSMS. DECISIONS WERE BASED ON THE PATIENT¿S CLINICAL CONDITION, ANEURYSM¿S MORPHOLOGY AND LOCATION, PRESENCE OF INTRACRANIAL MASS-OCCUPYING PROCESS (IMOP), ANGIOGRAPHIC FLOW DISTRIBUTION PATTERNS AND TREATMENT-RELATED RISK PROFIT. THE BENEFITS OF A JOINED CASE ASSESSMENT WERE RETROSPECTIVELY ANALYZED, COMPARING OUR CLINICAL AND RADIOLOGICAL RESULTS WITH THOSE OF THE AVERAGED LITERATURE SERIES. INITIALLY, 39 ANEURYSMS IN 34 PATIENTS WERE ENDOVASCULARLY (EV) TREATED AND 68 ANEURYSMS IN 66 PATIENTS WERE SURGICALLY (S) TREATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1003714 COIL-THERMO MECHANICAL NEUROVASCULAR EMBOLIZATION DEVICE KRD SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Life Threatening| R