BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM

    MDR report key: 16586106 · Received March 21, 2023

    Report

    Report Number
    2916596-2023-01510
    Event Type
    Injury
    Date Received
    March 21, 2023
    Date of Event
    June 18, 2019
    Report Date
    March 28, 2023
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013297
    PMA / PMN Number
    P160054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURE¿S INVESTIGATION CONCLUSION: A DIRECT CORRELATION BETWEEN THE DEVICE AND THE REPORTED CARDIAC ARRHYTHMIA COULD NOT BE CONCLUSIVELY ESTABLISHED THROUGH THIS EVALUATION. ADDITIONALLY, THE REPORTED LOW FLOW ALARMS COULD NOT BE CONFIRMED AS NO LOG FILES WERE SUBMITTED FOR REVIEW. THE PATIENT ULTIMATELY EXPIRED ON 27FEB2023 (CAPTURED UNDER MFR # 2916596-2023-01428). THE DEVICE WAS NOT EXPLANTED AND WAS NOT RETURNED FOR EVALUATION. THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS) INSTRUCTIONS FOR USE (IFU) IS CURRENTLY AVAILABLE. SECTION 1, "INTRODUCTION," LISTS CARDIA ARRHYTHMIA AS AN ADVERSE EVENT WHICH MAY BE ASSOCIATED WITH THE USE OF HEARTMATE 3 LVAS. SECTION 4, ¿SYSTEM MONITOR,¿ EXPLAINS THAT THE LOW FLOW HAZARD ALARM OCCURS WHEN PUMP FLOW IS LESS THAN 2.5 LITERS PER MINUTE (LPM). A 10-SECOND DELAY IS IMPOSED BETWEEN THE DETECTION OF THE LOW FLOW STATUS AND THE ACTIVATION OF THE ASSOCIATED AUDIO AND VISUAL INDICATORS ON THE SYSTEM CONTROLLER. CHANGES IN PATIENT CONDITIONS CAN RESULT IN LOW FLOW. SECTION 6, ¿PATIENT CARE AND MANAGEMENT," ALSO LISTS ARRHYTHMIA AS A POTENTIAL LATE POSTIMPLANT COMPLICATION. SECTION 7, ¿ALARMS AND TROUBLESHOOTING,¿ EXPLAINS ALL SYSTEM ALARMS AND THE RECOMMENDED ACTIONS ASSOCIATED WITH THEM. THE HEARTMATE 3 LVAS PATIENT HANDBOOK ALSO OUTLINES ALL SYSTEM CONTROLLER ALARMS AS WELL AS HOW TO RESPOND TO EACH ALARM CONDITION. THE RELEVANT SECTIONS OF THE DEVICE HISTORY RECORDS FOR (B)(6) WERE REVIEWED AND SHOWED NO DEVIATIONS FROM MANUFACTURING OR QUALITY ASSURANCE SPECIFICATIONS. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 0

    RELATED MFR DOCUMENTING RIGHT HEART FAILURE: # 2916596-2023-01508. NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE MANUFACTURER¿S INVESTIGATION IS COMPLETED. REPORTER POSTAL OFFICE OR ZIP CODE: (B)(6).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD VENTRICULAR TACHYCARDIA AND VENTRICULAR FIBRILLATION ON (B)(6) 2019. A REMOTE DEVICE CHECK SHOWED THAT THE PATIENT HAD 14 SEQUENCES OF ANTI-TACHYCARDIA PACING (ATP) AND 6 UNSUCCESSFUL SHOCKS IN RESTORING RHYTHM. THE PATIENT WAS CARDIOVERTED WITH ONE SHOCK OF 200 J BY THE EMERGENCY DEPARTMENT PHYSICIAN. THE PATIENT HAD BEEN ON TRIPLE THERAPY OF AMIODARONE, MEXITIL (MEXILETINE) AND QUINIDINE BUT CONTINUED TO HAVE VENTRICULAR TACHYCARDIA. THE PATIENT'S MILRINONE WAS STOPPED AS THE PATIENT WAS ALSO EXPERIENCING BRADYCARDIA. THE PATIENT RECEIVED CELIAC GANGLION BLOCK BY ANESTHESIA AND THE VENTRICULAR TACHYCARDIA CALMED DOWN. THE PATIENT HAD BEEN REFRACTORY TO MULTIPLE MEDICAL THERAPIES AND ABLATIONS AND WAS HAVING LOWER FLOWS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    358225 HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106524 6003297 00813024013297

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Male Required Intervention| O