BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS

    MDR report key: 4971229 · Received August 5, 2015

    Report

    Report Number
    2916596-2015-01431
    Event Type
    Injury
    Date Received
    August 5, 2015
    Date of Event
    July 8, 2015
    Report Date
    July 9, 2015
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    APPROXIMATE AGE OF DEVICE - 1 MONTH. THE PATIENT REMAINS ON LVAD SUPPORT. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETED.

    Additional Manufacturer Narrative · 1

    THE PATIENT REMAINS ON LVAD SUPPORT. A DIRECT CORRELATION BETWEEN THE DEVICE AND THE PATIENT¿S SUSPECTED THROMBUS COULD NOT BE CONCLUSIVELY DETERMINED. A REVIEW OF THE DEVICE HISTORY RECORD 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. IT WAS REPORTED THAT THE PATIENT EXPERIENCED HIGH POWERS AND FLOWS WITH A CONCURRENT DROP IN AVERAGE PULSATILITY INDEX (PI). THE PATIENT REPORTEDLY DEMONSTRATED UNSPECIFIED SIGNS AND SYMPTOMS OF THROMBUS. REVIEW OF THE DATA LOG FILE CONFIRMED THE OBSERVED PARAMETERS MAY BE POTENTIALLY LINKED TO THE PRESENCE OF THROMBUS. THE PATIENT¿ INTERNATIONAL NORMALIZED RATIO (INR) WAS REPORTED TO BE THERAPEUTIC AND NO COAGULOPATHIES WERE NOTED. NO FURTHER INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION PROVIDED ON (B)(6) 2015 INDICATED THAT AFTER DISCUSSION WITH THE LVAD COORDINATORS AND THE CLINICAL COORDINATOR, SUSPICION OF THROMBUS HAS BEEN RULED OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    511631 HEARTMATE II LVAS LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Other