BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE 3 LVAS IMPLANT KIT

    MDR report key: 18357204 · Received December 19, 2023

    Report

    Report Number
    2916596-2023-07642
    Event Type
    Injury
    Date Received
    December 19, 2023
    Date of Event
    June 21, 2022
    Report Date
    January 30, 2024
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013297
    PMA / PMN Number
    P160054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE 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 EVENTS COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS EVALUATION. THE PATIENT REMAINS ONGOING ON HEARTMATE 3 LVAS, SERIAL NUMBER (B)(6). 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), REV. A IS CURRENTLY AVAILABLE. THIS DOCUMENT LISTS POTENTIAL ADVERSE EVENTS WHICH MAY BE ASSOCIATED WITH THE USE OF HEARTMATE 3 LVAS, INCLUDING RIGHT HEART FAILURE. THE IFU STATES THAT PATIENTS MAY DEVELOP RIGHT VENTRICULAR FAILURE DURING OR SHORTLY AFTER IMPLANT. THIS DOCUMENT ALSO OUTLINES INDICATIONS OF RIGHT HEART FAILURE AND PROVIDES THE RECOMMENDED 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 DISCHARGE PROGRAM FOR PATIENTS WITH IMPLANTABLE LEFT VENTRICULAR ASSIST DEVICE (LVAD) AT THE HOSPITAL WAS ASSUMED TO BE APPROXIMATELY 2 MONTHS, WITH THE AIM OF ACQUIRING ACTIVITIES OF DAILY LIVING (ADL) AND IMPROVING EXERCISE TOLERANCE. THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR HEART FAILURE, BECAME CATECHOLAMINE DEPENDENT, AND LVAD IMPLANTATION WAS PERFORMED. EXERCISE TOLERANCE WAS MARKEDLY REDUCED (MAXIMUM OXYGEN INTAKE 9.0 ML/KG/MIN), ALTHOUGH THE PATIENT WAS ABLE TO WALK BEFORE SURGERY. THE GRIP STRENGTH WAS 26 KGF, AND THE RISING MOTION WAS LABORED AND SHOWED SIGNIFICANT WEAKNESS OF THE PROXIMAL LEG MUSCLES (UP TO 4 RISE TESTS). AFTER SURGERY, ADL ACQUISITION WAS DELAYED DUE TO DELAYED RIGHT HEART FAILURE AND RESTRICTED UPPER LIMB ACTIVITY ASSOCIATED WITH THORACOTOMY. SIX MONTHS AFTER SURGERY, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL WITH ADL AND TOLERABILITY. HOWEVER, THE GRIP STRENGTH WAS 22 KGF AND THE PERFORMANCE OF THE RISE OPERATION WAS ALSO DETERIORATED (5 RISE TESTS: 2 TIMES), SO THE PROBLEM REMAINED. THE PATIENT HAD LOWER MOTOR NEURONS (LMN)-RELATED MUSCULAR DYSTROPHY AND DILATED CARDIOMYOPATHY AND WAS DISCHARGED FROM THE HOSPITAL 6 MONTHS AFTER SURGERY. THIS PATIENT HAD DIFFICULTY IN MANAGING THE RISK OF POSTOPERATIVE HEART FAILURE AND INTERVENTION FOR SPECIFIC MUSCLE WEAKNESS DUE TO MUSCULAR DYSTROPHY, BUT WAS ABLE TO BE DISCHARGED FROM THE HOSPITAL AT HOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1459552 HEARTMATE 3 LVAS IMPLANT KIT VENTRICULAR (ASSIST) DEVICE DSQ THORATEC CORPORATION 106523 7987402 00813024013297

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Female Required Intervention| H