BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENUMBRA SYSTEM SEPARATOR 041

    MDR report key: 2923436 · Received January 22, 2013

    Report

    Report Number
    3005168196-2013-00037
    Event Type
    Injury
    Date Received
    January 22, 2013
    Date of Event
    October 26, 2010
    Report Date
    December 21, 2012
    Manufacturer
    PENUMBRA, INC.
    Product Code
    NRY
    PMA / PMN Number
    K072718
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: HEMORRHAGE IS A KNOWN AND ANTICIPATED COMPLICATION ASSOCIATED 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, QUALITY , OR DESIGN CONCERNS. DEVICE DISCARDED AFTER PROCEDURE.

    Description of Event or Problem · 1

    THE PATIENT EXPERIENCED AN INTRACRANIAL HEMORRHAGE ON (B)(6) 2010 AFTER BEING TREATED FOR AN ACUTE ISCHEMIC STROKE WITH THE PENUMBRA SYSTEM. THE EVENT WAS CONFIRMED ON THE PATIENT'S 24 HOUR CT SCAN AND WAS UNRESOLVED AT THE TIME OF STUDY COMPLETION. UPON A ROUTINE MONITORING VISIT CONDUCTED ON (B)(6) 2012, THE EVENT WAS DETERMINED TO BE OF MILD SEVERITY AND OF "UNCERTAIN" RELATIONSHIP TO THE PENUMBRA SYSTEM AND THE ANGIOGRAPHIC PROCEDURE. THE PATIENT SUBSEQUENTLY DIED ON (B)(6) 2010 DUE TO THE PROGRESSION OF THE STROKE. THIS MDR IS ASSOCIATED WITH MDR 3005168196-2013-00036.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    29397 PENUMBRA SYSTEM SEPARATOR 041 NRY NRY PENUMBRA, INC. F16735

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Other