BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM, NA

    MDR report key: 7836179 · Received August 30, 2018

    Report

    Report Number
    2916596-2018-03794
    Event Type
    Injury
    Date Received
    August 30, 2018
    Date of Event
    December 24, 2017
    Report Date
    October 8, 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

    DATE RECEIVED BY MANUFACTURER. A DIRECT CORRELATION BETWEEN HEARTMATE II LVAS, SERIAL NUMBER (B)(4), AND THE REPORTED EVENT COULD NOT CONCLUSIVELY BE ESTABLISHED THROUGH THIS EVALUATION. HEARTMATE II IFU LISTS HEMOLYSIS AS AN ADVERSE EVENT ASSOCIATED WITH THE USE OF THE HEARTMATE II LVAS, AND PROVIDES INFORMATION REGARDING THE RECOMMENDED ANTICOAGULATION. 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 THE DEVICE. THE MANUFACTURER IS CLOSING THE FILE FOR THIS EVENT.

    Additional Manufacturer Narrative · 1

    REFERENCED CEREBROVASCULAR ACCIDENT (CVA)/STROKE IS ADDRESSED IN MEDWATCH MFR # 2916596-2018-03354. AGE OF DEVICE: 2 YEARS, 8 MONTHS, 3 DAYS. THE PATIENT REMAINS ON LVAD SUPPORT WITH NO FURTHER ISSUES REPORTED. 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. PATIENT HAD AN INCREASE IN LACTATE DEHYDROGENASE (LDH) TO 1532 U/L WHERE UPPER LIMIT OF NORMAL IS 250 U/L. PATIENT WAS STARTED ON HEPARIN GTT. PLAVIX WAS ADDED TO ANTICOAGULATION REGIMEN (ASPIRIN). LDH DURING CEREBROVASCULAR ACCIDENT (CVA) WAS 535 U/L. LDH 8 DAYS PRIOR TO CVA WAS 1000 U/L. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    672659 HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM, NA LEFT VENTRICULAR ASSIST SYSTEM DSQ THORATEC CORPORATION 00813024011224

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Hospitalization| L