BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM, NA

    MDR report key: 8250874 · Received January 15, 2019

    Report

    Report Number
    2916596-2019-00237
    Event Type
    Injury
    Date Received
    January 15, 2019
    Date of Event
    March 7, 2017
    Report Date
    April 17, 2019
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024011224
    PMA / PMN Number
    P060040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: A DIRECT CORRELATION BETWEEN HEARTMATE II LVAS, SERIAL NUMBER (B)(4), AND THE REPORTED BLEEDING COULD NOT CONCLUSIVELY BE ESTABLISHED THROUGH THIS EVALUATION. THE ACCOUNT COMMUNICATED THAT PATIENT EXPERIENCED OROPHARYNGEAL BLEEDING ON (B)(6) 2017. NO ALARMS WERE REPORTED FOR THIS EVENT. REVIEW OF THE PATIENT¿S COMPLAINT HISTORY FOUND THAT THE PATIENT EXPERIENCED PREVIOUS BLEEDING EVENTS ON (B)(6) 2016 (CS-081973, COMPLAINT#(B)(4)) AND (B)(6) 2017 (CS-090506, COMPLAINT#(B)(4)); HOWEVER, THESE EVENTS WERE RELATED TO GASTROINTESTINAL BLEEDING AND NO ADDITIONAL OROPHARYNGEAL BLEEDING EVENTS HAVE BEEN REPORTED. THE PATIENT REMAINED ONGOING ON HEARTMATE II LVAS, SERIAL NUMBER (B)(4) UNTIL A PUMP EXCHANGE WAS PERFORMED DUE TO SUSPECTED PUMP THROMBOSIS ON (B)(6) 2017 (INVESTIGATED UNDER CS-090761, COMPLAINT#(B)(4)). PUMP THROMBOSIS WAS CONFIRMED THROUGH THE EVALUATION OF VAD-17712; HOWEVER, A DIRECT CORRELATION BETWEEN THIS FINDING AND THE REPORTED OROPHARYNGEAL BLEEDING COULD NOT BE CONCLUSIVELY ESTABLISHED THROUGH THIS EVALUATION. THE HMII LVAS IFU LISTS BLEEDING AS AN ADVERSE EVENT THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM AND OUTLINES THE RECOMMENDED ANTICOAGULATION THERAPY AND INR RANGE. THE REPORTED EVENT AND SUBSEQUENT INVESTIGATION DO NOT INDICATE AN ISSUE WITH THE MANUFACTURE OF THE PRODUCT. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THE EVENT.

    Additional Manufacturer Narrative · 1

    APPROXIMATE AGE OF DEVICE: 1 YEAR AND 2 MONTHS. THE PATIENT REMAINS ONGOING WITH THE LVAD DEVICE. NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    THE PATIENT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD) ON (B)(6) 2016. IT WAS REPORTED THAT ON (B)(6) 2017 THE PATIENT EXPERIENCED OROPHARYNGEAL BLEEDING. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    43669 HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM, NA LEFT VENTRICULAR ASSIST SYSTEM DSQ THORATEC CORPORATION 106015 00813024011224

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention