BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE 3 LVAS IMPLANT KIT

    MDR report key: 18677753 · Received February 9, 2024

    Report

    Report Number
    2916596-2024-00500
    Event Type
    Injury
    Date Received
    February 9, 2024
    Date of Event
    August 8, 2023
    Report Date
    April 10, 2024
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013297
    PMA / PMN Number
    P160054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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

    MANUFACTURER'S INVESTIGATION CONCLUSION: IT WAS REPORTED THAT THE PATIENT UNDERWENT A HEART TRANSPLANT. IT WAS LATER COMMUNICATED THAT THE PATIENT WAS NOT ELEVATED ON THE TRANSPLANT LIST SECONDARY TO A DEVICE OR THERAPY-RELATED ISSUE. ABBOTT DETERMINED THAT THIS EVENT DID NOT MEET THE REQUIREMENTS OF A COMPLAINT. THE RELEVANT SECTIONS OF THE DEVICE HISTORY RECORDS FOR MLP-031090 WERE REVIEWED AND SHOWED NO DEVIATION FROM MANUFACTURING OR QUALITY ASSURANCE SPECIFICATIONS. THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM INSTRUCTIONS FOR USE AND PATIENT HANDBOOK OUTLINE POTENTIAL ADVERSE EVENTS THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM, AS WELL AS INFORMATION REGARDING SYSTEM FUNCTION. 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 RECEIVED A HEART TRANSPLANT.

    Description of Event or Problem · 0

    THE PATIENT'S ULTIMATE GOAL WAS LEFT VENTRICULAR ASSIST DEVICE WITH BRIDGE TO TRANSPLANT AND THE DEVICE OPERATED AS EXPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    68569 HEARTMATE 3 LVAS IMPLANT KIT VENTRICULAR (ASSIST) DEVICE DSQ THORATEC CORPORATION 106524US 8358045 00813024013297

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Male Other