BEUDAMED
    FDA Adverse Event Death Summary report: N

    THORATEC® HEARTMATE II®, LVAS IMPLANT KIT

    MDR report key: 19553649 · Received June 17, 2024

    Report

    Report Number
    2916596-2024-03269
    Event Type
    Death
    Date Received
    June 17, 2024
    Date of Event
    May 22, 2024
    Report Date
    June 19, 2024
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024011996
    PMA / PMN Number
    P060040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    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 ONCE THE MANUFACTURER¿S INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 0

    SECTION D4: UDI: CORRECTED. MANUFACTURER'S INVESTIGATION CONCLUSION: A DIRECT CORRELATION BETWEEN HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM (LVAS), SERIAL NUMBER (B)(6) , AND THE PATIENT¿S OUTCOME COULD NOT BE CONCLUSIVELY ESTABLISHED THROUGH THIS EVALUATION. THE HEARTMATE II LVAS INSTRUCTIONS FOR USE (IFU) LISTS RIGHT HEART FAILURE AND RESPIRATORY FAILURE AS ADVERSE EVENTS THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM. THE IFU DISCUSSES THE POTENTIAL DEVELOPMENT OF RIGHT HEART FAILURE DURING USE OF THE HEARTMATE II LVAS AND OUTLINES THE ASSOCIATED TREATMENT OPTIONS. 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 II LEFT VENTRICULAR ASSIST SYSTEM (LVAS) INSTRUCTIONS FOR USE (IFU) IS CURRENTLY AVAILABLE. SECTION 1 ¿INTRODUCTION¿ OF THIS DOCUMENT LISTS RIGHT HEART FAILURE, RESPIRATORY FAILURE, AND DEATH AS ADVERSE EVENTS THAT MAY BE ASSOCIATED WITH THE USE OF HEARTMATE II LVAS. SECTION 6 ¿PATIENT CARE AND MANAGEMENT¿ (UNDER "RIGHT HEART FAILURE") DISCUSSES THE POTENTIAL DEVELOPMENT OF RIGHT HEART FAILURE DURING USE OF THE HEARTMATE II LVAS AND OUTLINES THE ASSOCIATED TREATMENT OPTIONS. 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 PASSED AWAY DUE TO RIGHT VENTRICULAR AND RESPIRATORY FAILURE. THE OUTCOME WAS NOT DEVICE OR THERAPY RELATED AND THE DEVICE WOULD NOT RETURN. THE RIGHT HEART FAILURE DID NOT EXIST PRIOR TO LEFT VENTRICULAR ASSIST DEVICE (LVAD) IMPLANT. A DEVICE RELATED ISSUE DID NOT CAUSE OR CONTRIBUTE TO THE RIGHT HEART FAILURE OR RESPIRATORY FAILURE AND THE RIGHT HEART AND RESPIRATORY FAILURE WAS CONSIDERED TO BE A PROGRESSION OF DISEASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2251015 THORATEC® HEARTMATE II®, LVAS IMPLANT KIT VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 107801 7263446 00813024011996

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Male Death