BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS

    MDR report key: 7421310 · Received April 11, 2018

    Report

    Report Number
    2916596-2018-01301
    Event Type
    Injury
    Date Received
    April 11, 2018
    Date of Event
    July 24, 2017
    Report Date
    May 1, 2018
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    UNIQUE IDENTIFIER (UDI) #: (DEVICE IDENTIFIER) - (B)(4). APPROXIMATE AGE OF DEVICE ¿ 42 DAYS. THE PUMP REMAINED IN USE SUPPORTING THE PATIENT AT THAT TIME. NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETED.

    Additional Manufacturer Narrative · 1

    PUMP EXCHANGE AND EVALUATION WAS REPORTED UNDER MEDWATCH MFR#2916546-2018-01063. ADDITIONAL INFORMATION: THROMBUS WAS CONFIRMED THROUGH THE EVALUATION OF THE LEFT VENTRICULAR ASSIST SYSTEM (LVAS) HOWEVER, A DIRECT CORRELATION BETWEEN THE RETURNED PUMP AND THE PATIENT¿S GI BLEEDING COULD NOT CONCLUSIVELY BE ESTABLISHED THROUGH THIS EVALUATION. THROMBUS AND BLEEDING ARE LISTED IN THE INSTRUCTIONS FOR USE AS A POTENTIAL ADVERSE EVENT THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM. A REVIEW OF THE DEVICE HISTORY RECORDS REVEALED THAT THE DEVICE MET APPLICABLE SPECIFICATIONS. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 1

    THE PATIENT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD) ON (B)(6) 2017. IT WAS REPORTED ON (B)(6) 2018, THAT THE PATIENT WAS ADMITTED INTO THE HOSPITAL ON (B)(6) 2017 DUE TO A GASTROINTESTINAL BLEED AND WAS MONITORED. NO OTHER TREATMENT WAS GIVEN. THE PATIENT WAS DISCHARGED ON (B)(6) 2017.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    264898 HEARTMATE II LVAS LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORPORATION 106015

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization