BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THORATEC® HEARTMATE 3® LVAS IMPLANT KIT

    MDR report key: 20696135 · Received November 15, 2024

    Report

    Report Number
    2916596-2024-07582
    Event Type
    Injury
    Date Received
    November 15, 2024
    Date of Event
    June 21, 2022
    Report Date
    December 3, 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
    117

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: A DIRECT CORRELATION BETWEEN HEARTMATE (HM) 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS), SERIAL NUMBER (B)(6), AND THE REPORTED EVENTS COULD NOT BE CONCLUSIVELY ESTABLISHED THROUGH THIS EVALUATION. THE PATIENT REMAINS ONGOING ON HEARTMATE 3 LVAS, SERIAL NUMBER (B)(6), AND NO FURTHER RELATED EVENTS HAVE BEEN REPORTED AT THIS TIME. THE HEARTMATE 3 LVAS INSTRUCTIONS FOR USE (IFU) LISTS POTENTIAL ADVERSE EVENTS, INCLUDING CARDIAC ARRHYTHMIA, THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM. THIS IFU ALSO LISTS ARRYTHMIA AS A POTENTIAL LATE POSTIMPLANT COMPLICATION. THE RELEVANT SECTIONS OF THE DEVICE HISTORY RECORDS FOR MLP-008049 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 OF THE IFU, ¿INTRODUCTION¿, LISTS ADVERSE EVENTS, INCLUDING CARDIAC ARRHYTHMIA, THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM. SECTION 6 OF THE IFU, ¿PATIENT CARE AND MANAGEMENT¿, LISTS ARRHYTHMIA AS A POTENTIAL LATE POSTIMPLANT COMPLICATION. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 0

    NO FURTHER INFORMATION PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE MANUFACTURER INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED ATRIAL FIBRILLATION (AF) WITH RAPID VENTRICULAR RESPONSE (RVR) WITH PRIOR ATRIOVENTRICULAR JUNCTION (AVJ) ON (B)(6) 2022. THE PATIENT EXPERIENCED SYMPTOMS OF DIZZINESS AND SYNCOPE. THE SITE REPORTED THAT THE ARRHYTHMIA RESULTED IN CLINICAL COMPROMISE FOR THE PATIENT. THE PATIENT HAD A KNOWN HISTORY OF AF AND VENTRICULAR TACHYCARDIA. THE ARRHYTHMIA WAS NOT THOUGHT TO BE DEVICE OR THERAPY RELATED. THE PATIENT HAD AN IMPLANTABLE CARDIOVERTER-DEFIBRILLATOR IMPLANTED PRIOR TO VAD IMPLANTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    74510 THORATEC® HEARTMATE 3® LVAS IMPLANT KIT VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106524US 6203903 00813024013297

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Male Other