BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN_NEUROVASCULAR_PRODUCT

    MDR report key: 3202952 · Received July 2, 2013

    Report

    Report Number
    3008853977-2013-00221
    Event Type
    Injury
    Date Received
    July 2, 2013
    Date of Event
    May 23, 2013
    Report Date
    June 14, 2013
    Manufacturer
    STRYKER NEUROVASCULAR CORK
    Product Code
    HCG
    PMA / PMN Number
    K093142
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT AVAILABLE FOR ANALYSIS. REVIEW AND ANALYSIS OF AVAILABLE INFORMATION FAILED TO IDENTIFY AN ASSIGNABLE CAUSE OR PROBABLE ASSIGNABLE CAUSE FOR THE REPORTED EVENT. THE DEVICE WAS NOT AVAILABLE TO THE MANUFACTURE.

    Description of Event or Problem · 1

    AT 17 DAYS POST SUCCESSFUL ANEURYSM EMBOLIZATION, THE COIL PROTRUDED FROM THE ANEURYSM TO THE PARENT VESSEL. THE PROTRUDED COIL WAS REMOVED FROM THE PATIENT. NO FURTHER DETAILS WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    302914 UNKNOWN_NEUROVASCULAR_PRODUCT DEVICE, NEUROVASCULAR EMBOLIZATION HCG STRYKER NEUROVASCULAR CORK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention