BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM, NA

    MDR report key: 7783446 · Received August 14, 2018

    Report

    Report Number
    2916596-2018-03257
    Event Type
    Injury
    Date Received
    August 14, 2018
    Date of Event
    January 2, 2018
    Report Date
    September 11, 2018
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024011224
    PMA / PMN Number
    P060040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    A DIRECT CORRELATION BETWEEN HEARTMATE II LVAS, SERIAL NUMBER (B)(4), AND THE REPORTED EVENT COULD NOT CONCLUSIVELY BE ESTABLISHED THROUGH THIS EVALUATION. THE HMII LVAS IFU LISTS DEVICE THROMBOSIS AND HEMOLYSIS AS ADVERSE EVENTS THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM. SECTION 6 "PATIENT CARE AND MANAGEMENT" OUTLINES THE RECOMMENDED ANTICOAGULATION THERAPY AND INR RANGE. THIS SECTION ALSO OUTLINES INDICATIONS OF PUMP THROMBOSIS, AS WELL AS HOW TO RESPOND TO SUCH EVENTS. THE RELEVANT SECTIONS OF THE DEVICE HISTORY RECORDS (DOCUMENTS #151291, 152326, AND 152816) FOR (B)(4) WERE REVIEWED AND SHOWED NO DEVIATIONS FROM MANUFACTURING OR QUALITY ASSURANCE SPECIFICATIONS. THE IMPLANT KIT SHIPPED ON (B)(6) 2015 VIA CUSTOMER ORDER (B)(4). THE PATIENT REMAINS ONGOING ON (B)(4). NO ADDITIONAL COMPLAINTS HAVE BEEN REPORTED AT THIS TIME. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE FOR THIS EVENT.

    Additional Manufacturer Narrative · 1

    THE EVENT DATE IS ESTIMATED. THE REFERENCED STROKE THE PATIENT EXPERIENCED ON (B)(6) 2018 IS REPORTED ON MEDWATCH MFR REPORT # 2916596-2018-03354. APPROXIMATE AGE OF DEVICE: 2 YEARS AND 8 MONTHS. THE PATIENT REMAINS ON LVAD SUPPORT. NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    THE PATIENT WAS IMPLANTED WITH LEFT VENTRICULAR ASSIST DEVICE (LVAD) ON (B)(6) 2015. IT WAS REPORTED THAT THE PATIENT HAD AN ELEVATED LACTATE DEHYDROGENATE (LDH) AND PUMP THROMBOSIS WAS SUSPECTED. THE PATIENT HAD AN ELEVATED LDH OF 1532 U/L (UPPER LIMIT OF NORMAL AT LAB IS 250 U/L) AND HEMOGLOBINURIA. THE PATIENT WAS STARTED ON A HEPARIN INFUSION AND PLAVIX IN ADDITION TO CONTINUING ON ASPIRIN. A PUMP EXCHANGE WAS BEING CONSIDERED, BUT THE PATIENT SUFFERED A CEREBRAL VASCULAR ACCIDENT (CVA) ON (B)(6) 2018. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    624326 HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM, NA LEFT VENTRICULAR ASSIST SYSTEM DSQ THORATEC CORPORATION 00813024011224

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Life Threatening