BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM, NA

    MDR report key: 7908530 · Received September 25, 2018

    Report

    Report Number
    2916596-2018-04016
    Event Type
    Injury
    Date Received
    September 25, 2018
    Date of Event
    January 8, 2018
    Report Date
    September 25, 2018
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024011224
    PMA / PMN Number
    P060040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE INITIAL SUBMISSION OF THIS EVENT WAS REPORTED BY THE MANUFACTURER UNDER MFT REPORT# 2916596-2018-00433. THIS REPORT IS BEING SUBMITTED AS ADDITIONAL INFORMATION. APPROXIMATE AGE OF DEVICE - 1 YEAR AND 2 MONTHS. MANUFACTURER'S INVESTIGATION CONCLUSION: NO PRODUCT WAS RETURNED FOR EVALUATION. A DIRECT CORRELATION BETWEEN THE DEVICE AND THE REPORTED ELEVATED LDH AND SUSPECTED PUMP THROMBOSIS COULD NOT CONCLUSIVELY BE ESTABLISHED THROUGH THIS EVALUATION. THE SUBMITTED LOG FILE CONTAINS DATA FROM (B)(6) 2017 AT 15:54:14 THROUGH (B)(6) 2018 AT 14:29:19. NO HAZARD ALARMS WERE CAPTURED FOR THE DURATION OF THE FILE. PUMP SPEED WAS SET TO 9000 RPM, POWER RANGED FROM 5.1-6.5 W, ESTIMATED FLOW RANGED FROM 4.7-7.6 LPM, AND AVERAGE PI WAS BETWEEN 4.2 AND 9.4. NO NOTABLE TRENDS IN PUMP PARAMETERS WERE OBSERVED. THE PUMP SPEED REMAINED ABOVE THE LOW SPEED LIMIT FOR THE DURATION OF THE FILE AND THE PUMP APPEARED TO FUNCTION AS INTENDED. THROMBUS AND HEMOLYSIS ARE LISTED IN THE INSTRUCTIONS FOR USE AS A POTENTIAL ADVERSE EVENT THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM. A REVIEW OF THE DEVICE HISTORY RECORDS REVEALED THAT THE DEVICE MET APPLICABLE SPECIFICATIONS. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 1

    THE PATIENT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD) ON (B)(6) 2016. IT WAS REPORTED THAT THE PATIENT¿S LACTATE DEHYDROGENASE (LDH) WAS IN THE 1000 U/L. THE PATIENT ALSO HAD BLOOD IN URINE. THERE WAS CONCERN OF PUMP THROMBOSIS. LOG FILE ANALYSIS REVEALED PARAMETERS CONSISTENT WITH DEVICE THROMBOSIS. ADDITIONAL INFORMATION WAS REQUESTED, BUT NONE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    745750 HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM, NA LEFT VENTRICULAR ASSIST SYSTEM DSQ THORATEC CORPORATION 106015 179912 00813024011224

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention