BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM

    MDR report key: 8174850 · Received December 18, 2018

    Report

    Report Number
    2916596-2018-05706
    Event Type
    Injury
    Date Received
    December 18, 2018
    Date of Event
    November 7, 2018
    Report Date
    March 12, 2021
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    PMA / PMN Number
    P160054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    A SPECIFIC CAUSE FOR THE PATIENT'S INFECTION COULD NOT CONCLUSIVELY BE DETERMINED THROUGH THIS EVALUATION. THE HEARTMATE 3 LVAS IFU LISTS INFECTION AS AN ADVERSE EVENT THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM. THE IFU, AS WELL AS THE HEARTMATE 3 LVAS PATIENT HANDBOOK, ALSO PROVIDE INFORMATION REGARDING HOW TO PREVENT INFECTION.THE RELEVANT SECTIONS OF THE DEVICE HISTORY RECORDS (DOC. #193308, 191100, 188310, 187022, 185387, 177654, AND 176552) WERE REVIEWED AND SHOWED NO DEVIATION FROM MANUFACTURING OR QUALITY ASSURANCE SPECIFICATIONS. REVIEW OF STERILIZATION AND PACKAGING DOCUMENTATION SHOWERED NO DEVIATION FROM MANUFACTURING SPECIFICATIONS. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 1

    NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 1

    REFERENCED PREVIOUS ADMISSION WAS REPORTED IN MEDWATCH REPORT # 2916596-2018-05345. 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). AGE OF DEVICE: 11 MONTHS, 2 DAYS. THE PATIENT REMAINS ON LVAD SUPPORT WITH NO FURTHER ISSUES REPORTED. 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 HAD A POSITIVE CULTURE FOR COAGULASE NEGATIVE STAPHYLOCOCCUS FROM THE DRAINAGE FLUID. THE INFECTION REPORTEDLY RESOLVED ON (B)(6) 2018.

    Description of Event or Problem · 1

    THE PATIENT WAS IMPLANTED WITH LEFT VENTRICULAR ASSIST DEVICE ON (B)(6) 2017. IT WAS REPORTED THAT PATIENT PRESENT WITH INCREASING BLEEDING AND PURULENT DRAINAGE FROM DRIVELINE INSERTION SITE. PATIENT WAS READMITTED ON (B)(6) 2018 FOR INFECTION. WOUND CULTURE WITH COAGULASE WAS NEGATIVE FOR STAPHYLOCOCCUS. PATIENT WAS ON DELAFLOXACIN. THE INFECTION STARTED AT ANOTHER FACILITY ON (B)(6) 2018 AND PATIENT DISCHARGED AND READMITTED TO THE CURRENT HOSPITAL FOR THE SAME INFECTION DUE TO COMPLICATIONS FROM TREATMENT. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1014872 HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM VENTRICULAR (ASSISST) BYPASS DSQ THORATEC CORPORATION 6036877

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Hospitalization| R