BEUDAMED
    FDA Adverse Event Death Summary report: N

    PENUMBRA SYSTEM 054

    MDR report key: 2023180 · Received February 15, 2011

    Report

    Report Number
    3005168196-2011-00113
    Event Type
    Death
    Date Received
    February 15, 2011
    Date of Event
    November 13, 2010
    Report Date
    February 17, 2011
    Manufacturer
    PENUMBRA INC.
    Product Code
    NRY
    PMA / PMN Number
    K090752
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: HEMORRHAGE IS A KNOWN AND ANTICIPATED COMPLICATION WITH THIS TYPE OF PROCEDURE AND IS NOTED IN THE DEVICE LABELING. THEREFORE, IT WAS DETERMINED THAT THE REPORTED EVENT WAS AN ANTICIPATED PROCEDURAL COMPLICATION. THE INFO IN THIS REPORT WAS COLLECTED DURING THE REVIEW OF STROKE CASES FOR A PENUMBRA PORT-MARKET RETROSPECTIVE STUDY (PICS). THE INFO AVAILABLE REGARDING THIS EVENT IS LIMITED TO THE PROCEDURAL REPORTS PROVIDED BY THE HOSPITAL.

    Description of Event or Problem · 1

    THE PT PRESENTED TO HOSPITAL ON (B)(6) 2010 WITH OCCLUSION OF THE RIGHT ICA AT THE ORIGIN AND A BASELINE (B)(4) OF 19. AFTER RECEIVING IV TPA AND A SLOW INFUSION OF 6 MG IA TPA, THE PT WAS TREATED WITH THE PENUMBRA SYSTEM 054. THE PT DEVELOPED A BRAIN HEMATOMA. THE HEMATOMA WAS DETERMINED BY THE PI, DR (B)(6), TO BE OF "POSSIBLE BUT NOT CERTAIN" RELATIONSHIP TO THE STUDY DEVICE AND ANGIOGRAPHIC PROCEDURE. THE EVENT WAS DETERMINED TO BE SEVERE AND WAS UNRESOLVED. BELOW IS TAKEN FROM AN EMAIL SENT BY DR (B)(6) REGARDING THE EVENT: "BRAIN HEMATOMA ALSO NOT LIKELY DUE TO THE DEVICE BUT RATHER DUE TO TPA. CANNOT EXCLUDE FACT THAT REPERFUSION WITH PENUMBRA AND TPA COMBO WERE SYNERGISTIC IN ETIOLOGY OF HEMATOMA, SO POSSIBLE BUT NOT CERTAIN." A NONCONTRAST CT ON (B)(6) 2010 SHOWED DEVELOPMENT OF MASS EFFECT AND MIDLINE SHIFT AND THE PT SUBSEQUENTLY EXPIRED ON (B)(6) 2010.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PENUMBRA SYSTEM 054 NRY PENUMBRA INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 92 YR Death