BEUDAMED
    FDA Adverse Event Death Summary report: N

    NEURON MAX 6F 088 LONG SHEATH

    MDR report key: 3064811 · Received April 17, 2013

    Report

    Report Number
    3005168196-2013-00143
    Event Type
    Death
    Date Received
    April 17, 2013
    Date of Event
    February 28, 2013
    Report Date
    March 18, 2013
    Manufacturer
    PENUMBRA, INC.
    Product Code
    DQY
    PMA / PMN Number
    K111380
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: DISSECTION AND EMBOLI ARE POTENTIAL ADVERSE EVENTS ASSOCIATED WITH TYPES OF PROCEDURES AND ARE NOTED IN THE DEVICE LABELING. THEREFORE, IT WAS DETERMINED THAT THE REPORTED EVENT WAS AN ANTICIPATED COMPLICATION. THE MANUFACTURING RECORDS FOR THIS LOT WERE REVIEWED AND DID NOT REVEAL ANY OUTSTANDING DISCREPANCIES, DESIGN, OR QUALITY CONCERNS. HOSPITAL DISCARDED OF DEVICE.

    Description of Event or Problem · 1

    DURING TREATMENT OF AN ANEURYSM USING A PIPLINE AND A NEURON MAX WITH A COIL BEHIND IT, THERE WAS DISSECTION TO THE ICA AND THE PATIENT DIED. THE OPERATORS DO NOT BELIEVE IT WAS THE FAULT OF THE NEURON MAX AS IT COULD HAVE HAPPENED WITH ANY CATHETER AND IT WAS A VERY DIFFICULT, COMPLEX CASE. IT WAS ALSO NOTED THAT DELIVERY OF THE PIPELINE DEVICE WAS DIFFICULT AND RESULTED IN EXTRA STRAIN ON THE NEURON MAX SHEATH THAN UNDER NORMAL CIRCUMSTANCES. THE PATIENT ALSO EXPERIENCED SPASM IN THE MCA A WEEK LATER THEN THOMBOSED OFF. THE PATIENT WAS TREATED WITH THE PENUMBRA SYSTEM TO REMOVE THE CLOT, BUT A FEW DAYS LATER, THE VESSEL CLOTTED OFF AGAIN AND THE PATIENT DIED. THE PATIENT APPEARED TO BE RESISTANT TO PLAVIX.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    164283 NEURON MAX 6F 088 LONG SHEATH DQY DQY PENUMBRA, INC. F29102

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Death| R