BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENUMBRA SYSTEM SEPARATOR 054

    MDR report key: 2092504 · Received May 3, 2011

    Report

    Report Number
    3005168196-2011-00196
    Event Type
    Injury
    Date Received
    May 3, 2011
    Date of Event
    September 21, 2010
    Report Date
    April 6, 2011
    Manufacturer
    PENUMBRA, INC.
    Product Code
    NRY
    PMA / PMN Number
    K090752
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: INTRACRANIAL 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 (B)(4). THE INFO AVAILABLE REGARDING THIS EVENT IS LIMITED TO THE PROCEDURAL REPORTS PROVIDED BY THE HOSPITAL. THIS MDR IS ASSOCIATED WITH MDR 3005168196-2011-00194 AND 3005168196-2011-00195.

    Description of Event or Problem · 1

    THE PT PRESENTED TO AN OUTSIDE HOSPITAL WITH ACUTE ONSET RIGHT HEMIPARESIS AND APHASIA. THE PT RECEIVED INFUSION OF IV TPA AT AN OUTSIDE HOSPITAL AND WAS TRANSFERRED TO (B)(6) WHERE HE WAS TREATED FOR AN OCCLUSION IN HIS LEFT M1 ON (B)(6) 2010. DURING THE PROCEDURE, THE PENUMBRA SYSTEM REPERFUSION CATHETER 054 WAS TRACKED COAXIALLY WITH THE REPERFUSION CATHETER 032 AND WAS THEN USED TO ASPIRATE THE OCCLUSION ALONG WITH THE PENUMBRA SYSTEM SEPARATOR 054. THROUGHOUT THE PROCEDURE, A TOTAL OF 7 MG IA TPA WERE ADMINISTERED BY SLOW IA INJECTION. AFTER CONCLUSION OF THE PROCEDURE, THERE WAS NOTED TO BE RECANALIZATION OF THE ANTERIOR PORTION OF THE MCA DISTRIBUTION BUT THE POSTERIOR DIVISION REMAINS LARGELY UNOPACIFIED EXCEPT FOR COLLATERAL FLOW. TICI 2A NOTED. ON (B)(6) 2010, IT WAS DETERMINED THAT THE PT EXPERIENCED PETECHIAL HEMORRHAGE WHICH RESOLVED THE SAME DAY. THIS EVENT WAS DETERMINED TO BE OF MILD SEVERITY WITH "POSSIBLE" RELATIONSHIP TO THE PENUMBRA SYSTEM AND ANGIOGRAPHIC PROCEDURE. FIVE DAYS AFTER THE PROCEDURE, THE PT WAS NOTED TO EXPERIENCE "MINOR HEMORRHAGIC CONVERSION" WHICH RESOLVED THE SAME DAY AND WAS DETERMINED TO BE OF "POSSIBLE" RELATIONSHIP TO THE PENUMBRA SYSTEM AND ANGIOGRAPHIC PROCEDURE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR