BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENUMBRA COIL 400

    MDR report key: 5458680 · Received February 24, 2016

    Report

    Report Number
    3005168196-2016-00257
    Event Type
    Injury
    Date Received
    February 24, 2016
    Date of Event
    December 25, 2014
    Report Date
    January 25, 2016
    Manufacturer
    PENUMBRA, INC.
    Product Code
    HCG
    UDI-DI
    00814548011349
    PMA / PMN Number
    K120330
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR EVALUATION. WITHOUT THE RETURN OF THE DEVICE, THE ROOT CAUSE OF THE PROBLEM CANNOT BE DETERMINED. THE MANUFACTURING RECORDS FOR THIS LOT WERE REVIEWED AND DID NOT REVEAL ANY OUTSTANDING DISCREPANCIES, DESIGN, OR QUALITY CONCERNS. THIS REPORT IS ASSOCIATED WITH MFR REPORT NUMBERS: 1. 3005168196-2016-00255 2. 3005168196-2016-00256 3. 3005168196-2016-00258. DEVICE WAS DISPOSED OF.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER? NO. THE INITIAL REPORT INDICATED THAT THE DEVICE WAS DISPOSED OF; HOWEVER, THIS SECTION SHOULD HAVE STATED THAT THE DEVICE IS NOT AVAILABLE FOR EVALUATION BECAUSE IT WAS IMPLANTED IN THE PATIENT.

    Description of Event or Problem · 1

    THE PATIENT SUCCESSFULLY UNDERWENT A COIL EMBOLIZATION PROCEDURE IN THE RIGHT MIDDLE CEREBRAL ARTERY (MCA) USING PENUMBRA COILS 400 (PC400 COILS). SIX MONTHS POST-PROCEDURE THE PATIENT EXPERIENCED TRANSIENT NEUROLOGIC DEFICIT AND WAS TREATED WITH PLAVIX. A MAGNETIC RESONANCE IMAGING/ANGIOGRAPHY (MRI/MRA) CONFIRMED THAT THIS SERIOUS ADVERSE EFFECT (TRANSIENT NEUROLOGIC DEFICIT) WAS RESOLVED. THIS SERIOUS ADVERSE EFFECT WAS ADJUDICATED TO HAVE AN UNCERTAIN RELATIONSHIP TO THE PC400 COILS, AND AN UNRELATED RELATIONSHIP TO BOTH THE ANGIOGRAPHIC PROCEDURE AND THE ANEURYSM/MALFORMATION DISEASE STATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    112674 PENUMBRA COIL 400 HCG, KRD HCG PENUMBRA, INC. F41357 00814548011349

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention