BEUDAMED
    FDA Adverse Event Death Summary report: N

    PENUMBRA SYSTEM SEPARATOR 032

    MDR report key: 2411745 · Received January 11, 2012

    Report

    Report Number
    3005168196-2012-00020
    Event Type
    Death
    Date Received
    January 11, 2012
    Date of Event
    August 4, 2011
    Report Date
    December 13, 2011
    Manufacturer
    PENUMBRA, INC.
    Product Code
    NRY
    PMA / PMN Number
    K072718
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: HEMORRHAGE AND ISCHEMIA ARE KNOWN AND ANTICIPATED COMPLICATIONS WITH THESE TYPES OF PROCEDURES AND ARE 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 DISPOSED OF BY HOSPITAL.

    Description of Event or Problem · 1

    THE PATIENT EXHIBITED SYMPTOMS OF AN ACUTE CEREBRAL INFARCTION ON (B)(6) 2011. THE PATIENT WAS DIAGNOSED WITH A RIGHT INTERNAL CAROTID ARTERY OCCLUSION. THE PENUMBRA SYSTEM AND MERCI RETRIEVAL SYSTEM WERE USED TO TREAT THE PATIENT; HOWEVER, THE DEVICES WERE NOT SUCCESSFUL IN REMOVING THE CLOT. THEN PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) WAS PERFORMED. THE BALLOON CATHETER REMOVED THE CLOT. THE PROCEDURE WAS FINISHED AND THE NEUROLOGICAL SYMPTOMS OF THE PATIENT REMAINED THE SAME AS BEFORE THE PROCEDURE. THE PATIENT'S BLOOD PRESSURE WAS NORMAL. DURING THE PROCEDURE, T-PA WAS ALSO ADMINISTERED. ON (B)(6) 2011, THE PATIENT EXPERIENCED HEMORRHAGIC INFARCTION AND PATIENT DEATH WAS CONFIRMED. THIS MDR IS ASSOCIATED WITH MDRS 3005168196-2012-00019, -00022.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PENUMBRA SYSTEM SEPARATOR 032 NRY NRY PENUMBRA, INC. F20268

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Death