BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENUMBRA SMART COIL

    MDR report key: 7088159 · Received December 6, 2017

    Report

    Report Number
    3005168196-2017-02153
    Event Type
    Injury
    Date Received
    December 6, 2017
    Date of Event
    September 12, 2017
    Report Date
    November 8, 2017
    Manufacturer
    PENUMBRA, INC.
    Product Code
    HCG
    UDI-DI
    00814548015231
    PMA / PMN Number
    K160832
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PLEASE NOTE THAT THE FOLLOWING SECTION WAS INCORRECTLY REPORTED ON THE INITIAL MFR REPORT AND IS BEING CORRECTED ON THIS FOLLOW-UP #01 MFR REPORT 3005168196-2017-02153:1.SECTION B. BOX 2. OUTCOMES ATTRIBUTED TO ADVERSE EVENT.

    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, NONCONFORMANCE, OR MISUSE THAT CONTRIBUTED TO THE REPORTED EVENT. THROMBOSIS IS A KNOWN AND ANTICIPATED COMPLICATION WITH THESE TYPES OF PROCEDURES AND IS NOTED IN THE DEVICE LABELING. THEREFORE, IT WAS DETERMINED THAT THE REPORTED ADVERSE EVENT WAS AN ANTICIPATED PROCEDURAL COMPLICATION. THE PRODUCT LOT NUMBER WAS NOT PROVIDED, THEREFORE, THE MANUFACTURING RECORDS COULD NOT BE REVIEWED. THIS REPORT IS ASSOCIATED WITH MFR REPORT NUMBER: 3005168196-2017-02152. THE DEVICE WAS IMPLANTED IN THE PATIENT.

    Description of Event or Problem · 1

    ON (B)(6) 2017, THE PATIENT UNDERWENT A COIL EMBOLIZATION PROCEDURE IN THE ANTERIOR CEREBRAL ARTERY (ACA) PERICALLOSAL USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, THERE WAS THROMBUS FORMATION IN THE PARENT VESSEL WHERE A STENT DEVICE WAS PLACED. THE PATIENT WAS GIVEN INTRA-ARTERIAL EPTIFIBATIDE INFUSION. THE EVENT WAS RESOLVED THE SAME DAY, ON (B)(6) 2017. THE THROMBUS FORMATION WAS ADJUDICATED TO BE AN ADVERSE EVENT WITH A DEFINITE RELATIONSHIP TO THE SMART COIL SYSTEM AND ANGIOGRAPHIC PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    866241 PENUMBRA SMART COIL HCG, KRD HCG PENUMBRA, INC. 00814548015231

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention