BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE II LVAS

    MDR report key: 6118972 · Received November 21, 2016

    Report

    Report Number
    2916596-2016-02284
    Event Type
    Death
    Date Received
    November 21, 2016
    Date of Event
    October 8, 2016
    Report Date
    October 26, 2016
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). APPROXIMATE AGE OF DEVICE ¿ 1 YEAR 11 MONTHS. (B)(4). ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS NOT PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER¿S INVESTIGATION IS COMPLETED.

    Additional Manufacturer Narrative · 1

    NO EQUIPMENT WAS RETURNED FOR EVALUATION. A CORRELATION BETWEEN THE DEVICE AND THE REPORTED INTRACRANIAL HEMORRHAGE, DEGENERATIVE NECK DISEASE, AND THE GASTROINTESTINAL BLEEDING COULD NOT BE CONCLUSIVELY DETERMINED. THE INSTRUCTIONS FOR USE LISTS STROKE AND BLEEDING AS POTENTIAL ADVERSE EVENTS THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM. A REVIEW OF THE DEVICE HISTORY RECORDS FOUND NO DEVIATIONS FROM MANUFACTURING SPECIFICATIONS. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING ITS FILE ON THIS EVENT.

    Description of Event or Problem · 1

    THE PATIENT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD). IT WAS REPORTED THAT THE PATIENT HAD RECURRING GASTROINTESTINAL (GI) BLEEDING THAT WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER. ESOPHAGOGASTRODUODENOSCOPIES (EGDS) AND BLEEDING SCANS WERE PERFORMED; HOWEVER, THE FINDINGS WERE NOT PROVIDED. INFORMATION ON THE TREATMENTS PROVIDED FOR THE GI BLEEDING WAS REQUESTED, BUT WAS NOT PROVIDED. DUE TO THE RECURRING GI BLEEDING THE PATIENT HAD AN INTERNATIONAL NORMALIZED RATIO (INR) GOAL BETWEEN 2 AND 2.5. ON APPROXIMATELY (B)(6) 2016 THE PATIENT REPORTED TO THE EMERGENCY ROOM COMPLAINING OF NECK PAIN. A CT OF THE PATIENT¿S NECK SHOWED DEGENERATIVE DISEASE IN THE CERVICAL SPINE THAT WAS INOPERABLE. THE PATIENT WAS TREATED MEDICALLY AND WITH PHYSICAL THERAPY. IT WAS REPORTED THAT ON (B)(6) 2016 THE PATIENT EXPIRED DUE TO INTRACEREBRAL HEMORRHAGE (ICH). THE PATIENT¿S INR WAS 2.3 AT THE TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    767112 HEARTMATE II LVAS LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Death