BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM

    MDR report key: 9203930 · Received October 17, 2019

    Report

    Report Number
    2916596-2019-05014
    Event Type
    Injury
    Date Received
    October 17, 2019
    Date of Event
    September 22, 2019
    Report Date
    November 22, 2019
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    PMA / PMN Number
    P160054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: A DIRECT RELATIONSHIP BETWEEN THE DEVICE AND THE REPORTED VENTRICULAR TACHYCARDIA COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS EVALUATION. THE CONTROLLER EVENT LOG FILE CONTAINED DATA ON (B)(6) 2019 FROM 4:52:55 AM TO 11:48:47 AM. THE PUMP WAS SET TO A FIXED SPEED OF 5200 RPM AND OPERATED AT OR ABOVE THE LOW SPEED LIMIT OF 4800 RPM FOR THE DURATION OF THE LOG FILE. THERE WERE NO ATYPICAL ALARMS AND THE LOG FILES APPEARED TO CAPTURE THE PUMP OPERATING AS INTENDED. THE ACCOUNT REPORTED THAT THE PATIENT WAS ADMITTED TO THE ED ON (B)(6) 2019 DUE TO LIGHTHEADEDNESS AND PALPITATIONS. INTERROGATION OF THE PATIENT¿S PACEMAKER SHOWED FREQUENT ATRIAL TACHYCARDIA IN THE RANGE OF 170-226 FOR 4 HOURS. THE PATIENT¿S BETA BLOCKER WAS CHANGED FROM CARVEDILOL TO METOPROLOL. THE CAUSE OF THE VENTRICULAR TACHYCARDIA REPORTEDLY WAS UNKNOWN. THE PATIENT REMAINED ONGOING ON THE HEARTMATE 3 LVAS UNTIL ULTIMATELY EXPIRING ON (B)(6) 2019 CAPTURED UNDER MFR# 2916596-2019-04958. CARDIAC ARRHYTHMIA IS LISTED AS AN ADVERSE EVENT 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.

    Additional Manufacturer Narrative · 1

    THE HEARTMATE 3 LVAS WAS IMPLANTED DURING THE (B)(6) CLINICAL TRIAL, IDE# (B)(4). FDA APPROVAL FOR HEARTMATE 3 LVAS WAS RECEIVED ON 23 AUGUST 2017. THE GTIN UNIQUE DEVICE IDENTIFIER FOR THE COMMERCIAL HEARTMATE3 LVAS IS (B)(4). NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER¿S INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD MULTIPLE EPISODES OF DIZZINESS AND EACH EPISODE LASTED A FEW SECONDS AND RESOLVED SPONTANEOUSLY. THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT COMPLAINING OF LIGHTHEADEDNESS AND PALPITATIONS AND THE PATIENT FELT THEIR HEART RACING FOR APPROXIMATELY 30 MINUTES. THE PATIENT'S PUMP WAS READING 3900 RPM WHEN IT USUALLY READS 5200 RPM. UPON INTERROGATION OF THEIR PACEMAKER, IT WAS NOTED THE PATIENT HAD FREQUENT ATRIAL TACHYCARDIA. THE RATE WAS 170-226 LASTING UP TO 4 HOURS. THE PATIENT'S BETA BLOCKER WAS CHANGED FROM CARDVEDILOL TO METOPROLOL. ADDITIONAL INFORMATION WAS RECEIVED THAT IT WAS UNCERTAIN IF OVER SUPPORT WAS POSSIBLE CAUSE OF THE ARRHYTHMIA AND VENTRICULAR TACHYCARDIA. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    995342 HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM VENTRICULAR (ASSISST) BYPASS DSQ THORATEC CORPORATION 106524 6372136

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization| R