BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE 3 LVAS IMPLANT KIT

    MDR report key: 16218611 · Received January 20, 2023

    Report

    Report Number
    2916596-2023-00195
    Event Type
    Injury
    Date Received
    January 20, 2023
    Date of Event
    May 1, 2019
    Report Date
    January 20, 2023
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    PMA / PMN Number
    P160054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: A SPECIFIC CAUSE FOR THE REPORTED TRANSPLANT COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS EVALUATION. ADDITIONALLY, A DIRECT CORRELATION BETWEEN HEARTMATE (HM) 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS), SERIAL NUMBER: (B)(4), AND THE EVENT(S) THAT PROMPTED THE TRANSPLANT COULD NOT BE CONCLUSIVELY ESTABLISHED. DUE TO PATIENT PRIVACY LAWS, THE ACCOUNT DECLINED TO PROVIDE PATIENT OUTCOME INFORMATION. BASED ON A REVIEW OF THE AVAILABLE PATIENT RECORDS, THERE WERE NO DEVICE ISSUES AT THE TIME OF THE PATIENT¿S TRANSPLANT, AND THE DEVICE HAD OPERATED AS INTENDED. HEARTMATE 3 LVAS, SERIAL NUMBER: (B)(4), WAS NOT RETURNED FOR EVALUATION. THE HEARTMATE 3 LVAS INSTRUCTIONS FOR USE (IFU) IS CURRENTLY AVAILABLE. ALTHOUGH NO DEVICE RELATED ISSUES WERE REPORTED BY THE ACCOUNT, THE IFU LISTS ADVERSE EVENTS THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM. THE RELEVANT SECTIONS OF THE DEVICE HISTORY RECORDS FOR MLP-010079 WERE REVIEWED AND SHOWED NO DEVIATIONS FROM MANUFACTURING OR QUALITY ASSURANCE SPECIFICATIONS. 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 UNDERWENT HEART TRANSPLANTATION ON (B)(6) 2019.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1984580 HEARTMATE 3 LVAS IMPLANT KIT VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106524INT 6422910

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention