BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENUMBRA SYSTEM REPERFUSION CATHETER 5MAX

    MDR report key: 2882829 · Received December 20, 2012

    Report

    Report Number
    3005168196-2012-00440
    Event Type
    Injury
    Date Received
    December 20, 2012
    Date of Event
    November 21, 2012
    Report Date
    November 21, 2012
    Manufacturer
    PENUMBRA, INC.
    Product Code
    NRY
    PMA / PMN Number
    K113163
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    HEMORRHAGE 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, QUALITY, OR DESIGN CONCERNS. DEVICES NOT RETAINED - UNDAMAGED.

    Description of Event or Problem · 1

    THE PATIENT PRESENTED TO (B)(6) WITH ACUTE LEFT M2 MCA OCCLUSION AND AN NIHSS OF 20 ON (B)(6) 2012. THE PATIENT RECEIVED FULL DOSE IV TPA AND WAS ENROLLED IN THE (B)(6), RANDOMIZED TO THE 3D-SEPARATOR ARM. THE TARGET OCCLUSION WAS ACCESSED INITIALLY BY A 5MAX CATHETER OVER A PENUMBRA VELOCITY MICROCATHETER AND SYNCHRO-2. THE 3D DEVICE WAS DEPLOYED INTO THE DISTAL M1 AFTER THE VELOCITY CATHETER WAS REMOVED, AND WAS LEFT FOR 5 MINUTES UNDER ASPIRATION. FOLLOWING ASPIRATION, FINAL REPERFUSION SCORE WAS TICI 2B AND THERE WERE NO IMMEDIATE COMPLICATIONS. THE NEXT DAY, (B)(6) 2012, THE SITE REPORTED FIRST IN A PHONE CALL THAT THE PATIENT HAD SUFFERED FROM A HEMORRHAGIC TRANSFORMATION THAT DAY. THE EVENT WAS FULLY REPORTED ON (B)(4) 2012 AS HAVING POSSIBLE RELATIONSHIP TO THE PENUMBRA SYSTEM, AND PROBABLE RELATIONSHIP TO THE ANGIOGRAPHIC PROCEDURE, THE IV TPA AND INDEX STROKE. THE EVENT WAS REPORTED AS A LARGE PH2 HEMORRHAGE, AND A SERIOUS ADVERSE EVENT, CONFIRMED BY IMAGING. TWO DAYS LATER, ON (B)(6) 2012 THE PATIENT WAS DISCHARGED TO COMFORT CARE AND EXPIRED THAT DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PENUMBRA SYSTEM REPERFUSION CATHETER 5MAX NRY NRY PENUMBRA, INC. F28257

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Death