BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM

    MDR report key: 7800275 · Received August 21, 2018

    Report

    Report Number
    2916596-2018-03195
    Event Type
    Injury
    Date Received
    August 21, 2018
    Date of Event
    February 12, 2018
    Report Date
    August 20, 2018
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    PMA / PMN Number
    P160054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE INITIAL SUBMISSION OF THIS EVENT WAS REPORTED BY THE MANUFACTURER UNDER MFR. REPORT # 2916596-2018-01263. THIS REPORT IS BEING SUBMITTED AS ADDITIONAL INFORMATION. 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. MANUFACTURER'S INVESTIGATION CONCLUSION: THE PATIENT REMAINS ONGOING ON THE DEVICE AND NO FURTHER EVENTS HAVE BEEN REPORTED AT THIS TIME. A SPECIFIC CAUSE FOR THE PATIENT'S INFECTION COULD NOT CONCLUSIVELY BE DETERMINED. INFECTION IS LISTED IN THE INSTRUCTIONS FOR USE AS A POTENTIAL ADVERSE EVENT THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM. THIS IFU, AS WELL AS THE HM3 LVAS PATIENT HANDBOOK, ALSO PROVIDE INFORMATION REGARDING HOW TO PREVENT INFECTION. A REVIEW OF THE DEVICE HISTORY RECORDS, INCLUDING THE STERILIZATION AND PACKAGING DOCUMENTATION, FOUND NO DEVIATIONS FROM MANUFACTURING SPECIFICATIONS. NO FURTHER INFORMATION IS AVAILABLE. 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 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
    642905 HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM LEFT VENTRICULAR ASSIST SYSTEM DSQ THORATEC CORPORATION 5956201

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention