BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENUMBRA SYSTEM 5MAX SEPARATOR

    MDR report key: 4031508 · Received August 22, 2014

    Report

    Report Number
    3005168196-2014-00553
    Event Type
    Injury
    Date Received
    August 22, 2014
    Date of Event
    December 25, 2013
    Report Date
    July 23, 2014
    Manufacturer
    PENUMBRA, INC.
    Product Code
    NRY
    PMA / PMN Number
    K100769
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: RE-OCCLUSION (DISTAL EMBOLIZATION) 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, DESIGN, OR QUALITY CONCERNS. THIS MDR IS ASSOCIATED WITH MDR 3005168196-2014-00551, 00552 AND 00576. THE HOSPITAL DISPOSED OF THE DEVICE.

    Description of Event or Problem · 1

    THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE RIGHT MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM 5MAX REPERFUSION CATHETER, 3MAX REPERFUSION CATHETER, 5MAX SEPARATOR, AND 3MAX SEPARATOR. PRIOR TO THE PROCEDURE, INTRAVENOUS TISSUE PLASMINOGEN ACTIVATOR (IV T-PA) WAS NOT ADMINISTERED. ASPIRATION WAS SUCCESSFULLY PERFORMED USING A 5MAX REPERFUSION CATHETER, 3MAX REPERFUSION CATHETER, 3MAX SEPARATOR AND 5MAX SEPARATOR. THE PATIENT WAS THEN GIVEN 4,000 UNITS OF HEPARIN BY INJECTION. DURING THE PROCEDURE IN THE M1, DISTAL EMBOLI OCCURRED IN THE M2 AND M3 WHICH WERE NOT REMOVED. THE PATIENT EXPERIENCED A CEREBRAL INFARCT; HOWEVER, THE SYMPTOMS DID NOT GET WORSE. THE PHYSICIAN CLOSELY MONITORED THE PATIENT'S CONDITION, BUT WITHHELD ANY ADDITIONAL TREATMENT AND THE PATIENT RECOVERED THREE DAYS LATER. PHYSICIAN'S COMMENT: SINCE REVERSE BLOOD FLOW IN THE M2 AND M3 WAS OBSERVED BEFORE THE OPERATION, IT IS HIGHLY POSSIBLE THAT A PART OF THE EMBOLI STRAYED INTO THE PERIPHERAL AREA. THE RELATION BETWEEN THE EVENT AND THE PENUMBRA SYSTEM WAS NOT DENIABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    509210 PENUMBRA SYSTEM 5MAX SEPARATOR NRY NRY PENUMBRA, INC. F37232

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Other