BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE II LVAS

    MDR report key: 6204932 · Received December 27, 2016

    Report

    Report Number
    2916596-2016-02520
    Event Type
    Death
    Date Received
    December 27, 2016
    Date of Event
    November 25, 2016
    Report Date
    May 18, 2017
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A CORRELATION BETWEEN THE DEVICE AND THE REPORTED GASTROINTESTINAL BLEEDING AND INTRACEREBRAL HEMORRHAGE COULD NOT BE CONCLUSIVELY DETERMINED. STROKE AND BLEEDING ARE LISTED IN THE INSTRUCTIONS FOR USE 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 REVEALED NO DEVIATIONS FROM MANUFACTURING OR QUALITY ASSURANCE SPECIFICATIONS. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 1

    (B)(4). APPROXIMATE AGE OF DEVICE ¿ 16 DAYS. NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER¿S INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION: IT WAS REPORTED THAT THE PATIENT EXPERIENCED GASTROINTESTINAL BLEEDING ON (B)(6) 2016; HOWEVER, THE SOURCE OF BLEEDING WAS NOT FOUND. THE PATIENT'S INR REMAINED AT 1.4 FOR MULTIPLE DAYS PRIOR TO THE EVENT AND THE PATIENT RECEIVED A CONTINUOUS INFUSION OF HEPARIN WITH A PARTIAL THROMBOPLASTIN TIME RANGING FROM 45 SECONDS TO 70 SECONDS. ON (B)(6) 2016, THE PATIENT WAS INTUBATED AND SEDATED. WHEN SEDATION WAS LIGHTENED, THE PATIENT REMAINED UNRESPONSIVE AND A CT SCAN REVEALED A LARGE INTRAPARENCHYMAL HEMORRHAGE WITH LARGE INTRAVENTRICULAR EXTENSION AND OBSTRUCTIVE HYDROCEPHALUS. THE PATIENT UNDERWENT VENTRICULOSTOMY DRAINAGE AND ANTICOAGULATION WAS THEN REVERSED.

    Description of Event or Problem · 1

    THE PATIENT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE. IT WAS REPORTED THAT THE PATIENT EXPIRED ON (B)(6) 2016. THE CAUSE FOR EXPIRATION WAS LISTED AS INTRACEREBRAL HEMORRHAGE. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    857136 HEARTMATE II LVAS LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Death