BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENUMBRA SMART COIL

    MDR report key: 7068216 · Received November 29, 2017

    Report

    Report Number
    3005168196-2017-02101
    Event Type
    Injury
    Date Received
    November 29, 2017
    Date of Event
    November 2, 2017
    Report Date
    November 3, 2017
    Manufacturer
    PENUMBRA, INC.
    Product Code
    HCG
    UDI-DI
    00814548015392
    PMA / PMN Number
    K160832
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR EVALUATION. FROM THE INFORMATION PROVIDED, THERE IS NO INDICATION THAT THERE WAS ANY DEVICE MALFUNCTION, NON-CONFORMANCE, OR MISUSE THAT CONTRIBUTED TO THE REPORTED EVENT. POTENTIAL ADVERSE EVENTS WITH THE PENUMBRA SMART COIL (SMART COIL) SYSTEM INCLUDE CEREBRAL ISCHEMIC EVENTS AND NEUROLOGICAL DEFICITS INCLUDING CEREBROVASCULAR ACCIDENT (CVA) AND ARE INCLUDED IN THE LABELING. THEREFORE, IT WAS DETERMINED THAT THE REPORTED CEREBROVASCULAR ACCIDENT WAS A POTENTIAL COMPLICATION RELATED TO THE USE OF THE SMART COIL SYSTEM. THE PRODUCT LOT NUMBER WAS NOT PROVIDED, THEREFORE, THE MANUFACTURING RECORDS COULD NOT BE REVIEWED. THIS REPORT IS ASSOCIATED WITH MFR REPORT NUMBERS: 1. 3005168196-2017-02099, 2. 3005168196-2017-02100, 3. 3005168196-2017-02102, 4. 3005168196-2017-02103. THE DEVICE WAS IMPLANTED IN THE PATIENT.

    Description of Event or Problem · 1

    THE PATIENT UNDERWENT A COIL EMBOLIZATION PROCEDURE ON (B)(6) 2017 USING FIVE PENUMBRA SMART COILS. WITHIN TWO HOURS AFTER THE PROCEDURE, THE PATIENT EXPERIENCED ACUTE NEUROLOGIC DECLINE AND BECAME HEMIPARETIC. THE PATIENT UNDERWENT AN ENDOVASCULAR REVASCULARIZATION THERAPY (ERT) WITH A SUCCESSFUL THROMBOLYSIS FOR ACUTE STROKE THERAPY AND RECANALIZATION OF THE RIGHT MIDDLE CEREBRAL ARTERY (MCA), ACHIEVING TICI GRADE 3 FLOW. THIS EVENT WAS RESOLVED ON (B)(6) 2017. THE CEREBROVASCULAR ACCIDENT (CVA) WAS ADJUDICATED TO BE A SERIOUS ADVERSE EVENT WITH A DEFINITE RELATIONSHIP TO THE DISEASE STATE, A DEFINITE RELATIONSHIP TO THE PROCEDURE, AND A PROBABLE RELATIONSHIP TO THE SMART COIL SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    846261 PENUMBRA SMART COIL HCG, KRD HCG PENUMBRA, INC. 00814548015392

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Life Threatening| R