BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNKNOWN_NEUROVASCULAR_PRODUCT

    MDR report key: 3070830 · Received April 22, 2013

    Report

    Report Number
    3008853977-2013-00107
    Event Type
    Death
    Date Received
    April 22, 2013
    Date of Event
    April 3, 2013
    Report Date
    April 8, 2013
    Manufacturer
    STRYKER NEUROVASCULAR CORK
    Product Code
    HCG
    PMA / PMN Number
    K093142
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SUBJECT DEVICE WAS IMPLANTED.

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE REMAINED IMPLANTED; THEREFORE, ANALYSIS CANNOT BE PERFORMED. BASED ON THE INFORMATION AVAILABLE, IT IS PROBABLE THAT PROCEDURAL FACTORS LIMITED THE DEVICE PERFORMANCE DURING PROCEDURE RESULTING IN THE COIL PROTRUSION. STROKE AND PATIENT OUTCOME OF DEATH ARE KNOWN RISKS ASSOCIATED WITH ENDOVASCULAR PROCEDURES AND IS NOTED AS SUCH IN THE DIRECTIONS FOR USE (DFU). THEREFORE, A ROOT CAUSE OF ANTICIPATED PROCEDURAL COMPLICATION HAS BEEN ASSIGNED TO THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A COIL EMBOLIZATION PROCEDURE, TWO LOOPS OF THE COIL PROTRUDED FROM THE ANEURYSM AND APPROXIMATELY 10 HOURS POST PROCEDURE, THE PATIENT SUFFERED A STROKE AND DIED. THE PHYSICIAN DID NOT RELATE THE STROKE AND PATIENT'S OUTCOME OF DEATH TO THE COIL PROTRUSION. NO OTHER INFORMATION IS AVAILABLE

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A COIL EMBOLIZATION PROCEDURE, TWO LOOPS OF THE COIL PROTRUDED FROM THE ANEURYSM AND APPROXIMATELY 10 HOURS POST PROCEDURE THE PATIENT SUFFERED A STROKE AND DIED. THE PHYSICIAN DID NOT RELATE THE STROKE AND PATIENT¿S OUTCOME OF DEATH TO THE COIL PROTRUSION. NO OTHER INFORMATION IS AVAILABLE

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    173128 UNKNOWN_NEUROVASCULAR_PRODUCT DEVICE, NEUROVASCULAR EMBOLIZATION HCG STRYKER NEUROVASCULAR CORK

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| O