BEUDAMED
    FDA Adverse Event Death Summary report: N

    PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER

    MDR report key: 3828234 · Received May 22, 2014

    Report

    Report Number
    3005168196-2014-00328
    Event Type
    Death
    Date Received
    May 22, 2014
    Date of Event
    January 13, 2014
    Report Date
    April 24, 2014
    Manufacturer
    PENUMBRA, INC.
    Product Code
    NRY
    PMA / PMN Number
    K113163
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: RE-OCCLUSION 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 EVENT WAS AN ANTICIPATED PROCEDURAL COMPLICATION. THE MANUFACTURING RECORDS FOR THIS LOT WERE REVIEWED AND DID NOT REVEAL ANY OUTSTANDING DISCREPANCIES, DESIGN, OR QUALITY CONCERNS. THIS MDR IS ASSOCIATED WITH MDR 3005168196-2014-00329, 00330, AND 00331. DEVICE WAS DISPOSED OF BY THE HOSPITAL.

    Description of Event or Problem · 1

    THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE RIGHT MIDDLE CEREBRAL ARTERY (MCA, M2) USING A PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER/SEPARATOR AND PENUMBRA SYSTEM 4MAX REPERFUSION CATHETER/SEPARATOR. BEFORE THE PROCEDURE, THE PATIENT WAS GIVEN 20,880,000 UNITS OF INTRAVENOUS TISSUE PLASMINOGEN (IV T-PA). DURING THE PROCEDURE, A 3MAX REPERFUSION CATHETER WAS ADVANCED TO THE M2 ALONG WITH A CHIKAI 0.014 INCH THROUGH AN OPTIMO GUIDE CATHETER 8F. ASPIRATION WAS CONDUCTED WITH A 3MAX SEPARATOR. FOLLOWING ASPIRATION, THE PATIENT WAS NOT GIVEN HEPARIN. THE PATIENT DEVELOPED AN OCCLUSION IN THE MCA (M1). RECANALIZATION IN THE M1 WAS SUCCEEDED BY ASPIRATION WITH A 4MAX REPERFUSION CATHETER AND A 4MAX SEPARATOR; HOWEVER, THE M2 COULD NOT BE RECANALIZED. UNFORTUNATELY, THE PATIENT EXPIRED APPROXIMATELY 2 WEEKS AFTER THE PROCEDURE. PHYSICIAN'S COMMENT: THE PROXIMAL MCA WAS OCCLUDED DURING THE OPERATION. THE CLOT FORMED PROBABLY DUE TO INSERTION OF THE CATHETER. THE EVENT WAS RELATED TO THE PENUMBRA SYSTEM AND THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    306224 PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER NRY NRY PENUMBRA, INC. F35616

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Death