BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM

    MDR report key: 7401898 · Received April 6, 2018

    Report

    Report Number
    2916596-2018-01263
    Event Type
    Injury
    Date Received
    April 6, 2018
    Date of Event
    February 12, 2018
    Report Date
    April 5, 2018
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE HEARTMATE 3 LVAS WAS IMPLANTED DURING THE MOMENTUM 3 CLINICAL TRIAL, IDE# (B)(4). FDA APPROVAL FOR HEARTMATE 3 LVAS WAS RECEIVED ON 23 AUGUST 2017. THE SAME DEVICE IS USED COMMERCIALLY AND IN THE ONGOING MOMENTUM 3 TRIAL. THE GTIN UNIQUE DEVICE IDENTIFIER FOR THE COMMERCIAL HEARTMATE3 LVAS IS (B)(4). APPROXIMATE AGE OF DEVICE- 9 MONTHS. THE PATIENT REMAINS ONGOING WITH THE LVAD DEVICE. 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 A LEFT VENTRICULAR ASSIST DEVICE (LVAD) ON (B)(6) 2017. IT WAS REPORTED THAT ON (B)(6) 2018 THE PATIENT PRESENTED WITH IRRITATION AT THEIR DRIVELINE SITE. THE PATIENT WAS STARTED ON 25MG OF ATARAX EVERY 8 HOURS WHEN NECESSARY (PNR). ON (B)(6) 2018 (10 DAYS LATER), THE PATIENT REPORTED THAT THEIR DRIVELINE EXIT SITE (DLES) HAS BEEN HURTING AND SHOWED REDNESS AND BLOODY DISCHARGE. THE PATIENT WAS STARTED ON KEFLEX AND TOPICAL CORTISONE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    245897 HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention