BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS

    MDR report key: 6672661 · Received June 28, 2017

    Report

    Report Number
    2916596-2017-01339
    Event Type
    Injury
    Date Received
    June 28, 2017
    Date of Event
    May 30, 2017
    Report Date
    November 6, 2017
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). APPROXIMATE AGE OF DEVICE - 20 DAYS. NO ADDITIONAL INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETED.

    Additional Manufacturer Narrative · 1

    A CORRELATION BETWEEN THE DEVICE AND THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED. HEMOLYSIS IS LISTED IN THE INSTRUCTIONS FOR USE AS A POTENTIAL ADVERSE EVENT THAT MAY BE ASSOCIATED WITH THE USE OF HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM. THE PATIENT REMAINS ON VAD SUPPORT. A REVIEW OF THE DEVICE HISTORY RECORDS REVEALED 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) 2017. IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE VAD CLINIC ON (B)(6) 2017 WITH SYMPTOMS OF DIZZINESS AND WEAKNESS. THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR EVALUATION DUE TO AN ELEVATED LACTATE DEHYDROGENASE (LDH) OF 748 U/L (BASELINE RANGE OF 125-220 U/L) AND ELEVATED FREE HEMOGLOBIN OF 70 G/DL (REFERENCE RANGE LESS THAN 30 G/DL). THE PATIENT WAS STARTED ON A HEPARIN INFUSION. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED ON 30AUG2017, STATED THAT THE PATIENT CONTINUED TO HAVE ELEVATED LACTATE DEHYDROGENASE (LDH) AND PLASMA FREE HEMOGLOBIN (PFH). THE PATIENT WAS DISCHARGED ON (B)(6) 2017 WITH AWARENESS OF RISK OF THROMBOSIS. THE PATIENT'S LDH AND PFH REMAINED ELEVATED UNTIL (B)(6) 2017. DURING A CLINIC VISIT ON (B)(6) 2017, THE PATIENT LDH WAS 297 U/L AND PFH WAS LESS THAN 30 G/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    454443 HEARTMATE II LVAS LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization| R