BEUDAMED
    FDA Adverse Event Death Summary report: N

    PENUMBRA SYSTEM SEPARATOR 054

    MDR report key: 3794327 · Received May 6, 2014

    Report

    Report Number
    3005168196-2014-00272
    Event Type
    Death
    Date Received
    May 6, 2014
    Date of Event
    November 27, 2012
    Report Date
    April 6, 2014
    Manufacturer
    PENUMBRA, INC.
    Product Code
    NRY
    PMA / PMN Number
    K090752
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: DISSECTION 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 3005168196-2014-00270, 00271 AND 00273. DEVICE WAS DISPOSED OF BY HOSPITAL.

    Description of Event or Problem · 1

    THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE LEFT INTERNAL CAROTID ARTERY (ICA) USING A PENUMBRA SYSTEM REPERFUSION CATHETER 054/041 AND SEPARATOR 054/041. BEFORE THE PROCEDURE, 12,480,000 UNITS OF INTRAVENOUS TISSUE PLASMINOGEN (IV T-PA) WERE ADMINISTERED. DURING THE PROCEDURE, A REPERFUSION CATHETER 054 WAS ADVANCED TO THE C2 ALONG WITH A CHIKAI 0.014 INCH THROUGH AN OPTIMO GUIDE CATHETER 9FR. ASPIRATION WAS CONDUCTED WITH THE REPERFUSION CATHETER 054 IN THE C2, A REPERFUSION CATHETER 041 AND A SEPARATOR 041 IN THE M2, A REPERFUSION CATHETER 054 AND A SEPARATOR 054 IN THE C4, AND WITH A REPERFUSION CATHETER 041 AND A SEPARATOR 041 IN THE M1. THE PATIENT WAS THEN GIVEN 11,000 UNITS OF HEPARIN THROUGH INJECTION. THE PATIENT WAS THEN GIVEN 60,000 UNITS OF UK THROUGH INJECTION INTO THE LEFT SELECTIVE ICA, AND 120,000 UNITS OF UK INTO THE SELECTIVE RIGHT ICA. THE PATIENT HAD A DISSECTION IN THE ORIGIN OF THE LEFT ICA. A STENT WAS PLACED DUE TO THE DISSECTION. APPROXIMATELY TWO DAYS LATER, THE PATIENT EXPIRED. PHYSICIAN'S COMMENT: DUE TO THE PATIENT'S TORTUOUS ANATOMY, I COULD NOT TORQUE THE DEVICE AS PLANNED. THE TORQUED DEVICE PRESSED THE ICA AND CAUSED DISSECTION. THE RELATION BETWEEN THE EVENT AND THE PENUMBRA SYSTEM WAS NOT DENIAL. THE PATIENT ALREADY DEVELOPED MASSIVE BRAIN INJURY OWING TO ICA OCCLUSION ON BOTH SIDES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272190 PENUMBRA SYSTEM SEPARATOR 054 NRY NRY PENUMBRA, INC. F24437

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Death