BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE 3 LVAS IMPLANT KIT

    MDR report key: 14078317 · Received April 11, 2022

    Report

    Report Number
    2916596-2022-01948
    Event Type
    Injury
    Date Received
    April 11, 2022
    Date of Event
    February 28, 2022
    Report Date
    April 28, 2022
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013297
    PMA / PMN Number
    P160054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER¿S INVESTIGATION IS COMPLETED.

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: A DIRECT CORRELATION BETWEEN HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS), SERIAL NUMBER (B)(6) , AND THE REPORTED EVENT COULD NOT BE CONCLUSIVELY ESTABLISHED THROUGH THIS EVALUATION. THE PATIENT REMAINS ONGOING ON (B)(6), WITH NO FURTHER REPORTED ISSUES AT THIS TIME. THE RELEVANT SECTIONS OF THE DEVICE HISTORY RECORDS FOR (B)(6), WERE REVIEWED AND SHOWED NO DEVIATIONS FROM MANUFACTURING OR QUALITY ASSURANCE SPECIFICATIONS. THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS) INSTRUCTIONS FOR USE (IFU) IS CURRENTLY AVAILABLE. SECTION 1 ¿INTRODUCTION¿ OF THIS DOCUMENT LISTS RIGHT HEART FAILURE AND RESPIRATORY FAILURE AS ADVERSE EVENTS THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE 3 LVAS. ADDITIONALLY, SECTION 6 ¿PATIENT CARE AND MANAGEMENT¿ LISTS RIGHT HEART FAILURE AS A POTENTIAL RISK/ADVERSE EVENT THAT MAY BE ASSOCIATED WITH THE USE OF HEARTMATE 3 LVAS. THIS SECTION (UNDER ¿RIGHT HEART FAILURE¿) ALSO OUTLINES INDICATIONS OF RIGHT HEART FAILURE AS WELL AS POSSIBLE TREATMENTS. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED RIGHT HEART FAILURE ON (B)(6) 2022. TRACHEAL INTUBATION WAS INITIATED DUE TO INCREASED OXYGEN DEMAND DUE TO BOTH PLEURAL EFFUSION AND WORSENING RIGHT HEART FAILURE. THE EVENT RESOLVED WITHOUT SEQUELAE ON (B)(6) 2022.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1639717 HEARTMATE 3 LVAS IMPLANT KIT VENTRICULAR (ASSISST) BYPASS DSQ THORATEC CORPORATION 106524US 8196713 00813024013297

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Male Required Intervention| H