BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THORATEC® HEARTMATE 3® LVAS IMPLANT KIT

    MDR report key: 19136252 · Received April 18, 2024

    Report

    Report Number
    2916596-2024-02078
    Event Type
    Injury
    Date Received
    April 18, 2024
    Date of Event
    June 28, 2023
    Report Date
    July 31, 2024
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    PMA / PMN Number
    P160054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    117

    Narratives

    Additional Manufacturer Narrative · 0

    E4: VOLUNTARY MEDWATCH NUMBER (B)(4). 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: 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 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. C, IS CURRENTLY AVAILABLE. SECTION 1, "INTRODUCTION," LISTS ADVERSE EVENTS, INCLUDING CARDIAC ARRHYTHMIA AND HYPERTENSION, THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT STATUS POST HEARTMATE 3 LEFT VENTRICULAR ASSIST DEVICE (LVAD) IMPLANT WAS COURSE COMPLICATED BY VENTRICULAR TACHYCARDIA (VT) STORM WHICH REQUIRED RIGHT VENTRICULAR PROTEK. THE PATIENT HAD AN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) IMPLANTED PRIOR TO LVAD WHICH WAS REPLACED POST LVAD IMPLANT DUE TO BATTERY DEPLETION. THE ICD IN PLACE WAS COMPLICATED BY MULTIPLE EPISODES OF SYMPTOMATIC VT, ATRIAL FIBRILLATION (AF), PULMONARY HYPERTENSION (PH). THE PATIENT WAS NOTED TO HAVE HAD HYPOTENSION. THE PATIENT HAD A HISTORY OF VT AND AF PRE-LVAD IMPLANT AND THE ARRHYTHMIA WAS NOT THOUGHT TO BE DEVICE OR THERAPY RELATED. THE ARRHYTHMIA RESULTED IN CLINICAL COMPROMISE OF HYPOTENSION AND WAS TREATED WITH STELLATE GANGLION BLOCK ON (B)(6) 2023 AND VENTRICULAR ABLATION (B)(6) 2023 THE TREATMENT RESOLVED THE EVENT. RELATED MANUFACTURER REFERENCE NUMBER: 2916596-2024-01099 (HEARTMATE 3 LVAS, OTHER INFORMATION REPORTED IN VOLUNTARY MEDWATCH)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2288992 THORATEC® HEARTMATE 3® LVAS IMPLANT KIT VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106524US 8943085

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Male Required Intervention| L