BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM

    MDR report key: 15508530 · Received September 29, 2022

    Report

    Report Number
    2916596-2022-13633
    Event Type
    Injury
    Date Received
    September 29, 2022
    Date of Event
    November 1, 2018
    Report Date
    September 29, 2022
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    PMA / PMN Number
    P160054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    SPECIFIC PATIENT INFORMATION AND DEVICE SERIAL NUMBER ARE DOCUMENTED AS UNKNOWN. B3: DATE OF EVENT IS MID-POINT APPROXIMATE AS THE DATA WERE COLLECTED BETWEEN (B)(6) 2018 AND (B)(6) 2019. INITIAL REPORTER NAME AND ADDRESS: (B)(6). ARTICLE CITATION - M. LYLE, ET AL. STEREOTACTIC BODY RADIATION FOR REFRACTORY VENTRICULAR TACHYCARDIA IN PATIENTS WITH LEFT VENTRICULAR ASSIST DEVICES. VOLUME 39, ISSUE 4, 2020 APRIL 01. DOI: 10.1016/J.HEALUN.2020.01.402. CARDIOLOGY, EMORY UNIVERSITY, ATLANTA, GA. THE REPORTABLE AWARE DATE IS THE DATE THE SJM NOTIFIER COMPLETED READING THE ARTICLE AND ENTERED IN THE COMPLAINT DATABASE. MANUFACTURE¿S INVESTIGATION CONCLUSION: A DIRECT CORRELATION BETWEEN THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS) AND THE REPORTED EVENTS COULD NOT BE DETERMINED THROUGH THIS EVALUATION. THE HEARTMATE 3 DEVICE SERIAL NUMBER AND OTHER SPECIFIC CASE/PATIENT INFORMATION WERE NOT AVAILABLE AND WERE NOT REQUESTED. NO PRODUCT WAS EVALUATED UNDER THIS COMPLAINT. THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS) INSTRUCTION FOR USE (IFU), IS CURRENTLY AVAILABLE. ALTHOUGH THE ACCOUNT COMMUNICATED THAT THE PATIENT HAS A KNOWN HISTORY OF ARRHYTHMIA, SECTION 1 "INTRODUCTION" OF THIS IFU LISTS CARDIAC ARRHYTHMIA AS AN ADVERSE EVENT THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM. ADDITIONALLY, SECTION 6 ¿PATIENT CARE AND MANAGEMENT¿ LISTS ARRHYTHMIA AS A POTENTIAL LATE POSTIMPLANT COMPLICATION THAT MAY BE ASSOCIATED WITH THE USE OF HEARTMATE 3 LVAS. THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED AS THE HEARTMATE 3 DEVICE SERIAL NUMBER, AS WELL AS OTHER SPECIFIC CASE/PATIENT INFORMATION, ARE NOT AVAILABLE AND WERE NOT REQUESTED. 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 PATIENT HAD NON-ISCHEMIC CARDIOMYOPATHY AND VENTRICULAR TACHYCARDIA (VT) REFRACTORY TO MEDICAL THERAPY AND STELLATE GANGLION BLOCK. THE PATIENT UNDERWENT HEARTMATE 3 LVAD IMPLANTATION FOR THEIR INTRACTABLE VT AND CARDIOGENIC SHOCK. POST LVAD IMPLANTATION, THE PATIENT CONTINUED TO HAVE REFRACTORY VT DESPITE SUBSEQUENT VT ABLATIONS. COMPUTED TOMOGRAPHY (CT) CARDIAC MAPPING IDENTIFIED A 4 MM ARRHYTHMIC SCAR ALONG THE LATERAL WALL OF THE RIGHT VENTRICLE, AND STEREOTACTIC BODY RADIATION THERAPY (SBRT) WAS PERFORMED WITH A SINGLE FRACTION OF 25 GY. TWO WEEKS AFTER SBRT, HE EXPERIENCED RECURRENT VT AND EVENTUALLY UNDERWENT ORTHOTOPIC HEART TRANSPLANTATION (OHT) FOUR MONTHS AFTER VT RECURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1616879 HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM DSQ THORATEC CORPORATION 100169571

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Male Required Intervention| H