BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COIL-THERMO MECHANICAL

    MDR report key: 8162130 · Received December 13, 2018

    Report

    Report Number
    2954740-2018-00523
    Event Type
    Injury
    Date Received
    December 13, 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, ¿THE INFLUENCE OF CONFIGURATION AND LOCATION OF RUPTURED DISTAL CEREBRAL ANTERIOR ARTERY ANEURYSMS ON THEIR TREATMENT MODALITY AND RESULTS: ANALYSIS OF OUR CASUISTRY AND LITERATURE REVIEW ¿ A PATIENT (FROM ENDOVASCULAR GROUP) WITH TWO SIMULTANEOUS ENDOVASCULARLY TREATED ANEURYSMS WITH COILS: ORBIT (ANTERIOR COMMUNICATING ARTERY AND A SUPRACALLOSAL ANEURYSM WITH BASIC CONFIGURATION)) SUFFERED A MULTIPLE BRAIN INFARCTS SYNDROME FOLLOWING DIFFUSE VASOSPASM. OBJECTIVE: TO ASSESS THE INFLUENCE OF CONFIGURATION AND LOCATION OF RUPTURED DISTAL CEREBRAL ANTERIOR ARTERY ANEURYSMS ON THEIR TREATMENT MODALITY AND RESULTS. METHOD: THE INFLUENCE OF THE ANEURYSM CONFIGURATION (BASIC OR COMPLEX CONFIGURATION) AND LOCATION (INFRACALLOSAL OR SUPRACALLOSAL) ON THE TREATMENT-RELATED RADIOLOGICAL RESULTS (PARTIAL OR COMPLETE ANEURYSM OCCLUSION) AND CLINICAL OUTCOME (FAVORABLE OR UNFAVORABLE) WAS RETROSPECTIVELY ANALYSED IN ALL ADMITTED PATIENTS WITH RUPTURED PERICALLOSAL ANEURYSMS WITHIN THE LAST 10 YEARS. THE EXPECTED BENEFIT FROM EACH FORM OF TREATMENT WAS INDIVIDUALLY DISCUSSED. DURING THIS PERIOD, 21 PATIENTS WITH RUPTURED PERICALLOSAL ANEURYSMS HAD BEEN ADMITTED (10 PATIENTS - ENDOVASCULAR GROUP AND 11 PATIENTS- SURGICAL GROUP).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1002790 COIL-THERMO MECHANICAL NEUROVASCULAR EMBOLIZATION DEVICE KRD SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Life Threatening