BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE

    MDR report key: 3142635 · Received May 30, 2013

    Report

    Report Number
    2916596-2013-00641
    Event Type
    Death
    Date Received
    May 30, 2013
    Date of Event
    April 16, 2013
    Report Date
    May 3, 2013
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE INFORMATION AVAILABLE TO THE MANUFACTURER, THE REPORT OF THROMBUS COULD NOT BE CONFIRMED AS THE DEVICE WAS NOT AVAILABLE FOR EVALUATION. A REVIEW OF DEVICE HISTORY RECORDS SHOWED NO DEVIATIONS FROM MANUFACTURING OR QA SPECIFICATIONS. ALTHOUGH A ROOT CAUSE FOR THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED, DEVICE THROMBOSIS IS LISTED IN THE APPROVED LABELING AS AN ADVERSE EVENT THAT MAY BE ASSOCIATED WITH THE USE OF THE LEFT VENTRICULAR ASSIST SYSTEM (LVAS). NO FURTHER INFORMATION IS AVAILABLE. THE MANUFACTURER IS CLOSING ITS FILE ON THIS EVENT. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. (B)(4). A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MFR'S INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    THE PT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE. AN (B)(6) REPORT WAS RECEIVED WHICH INDICATED "PT'S PI DROPPED AND POWER ON HIS LVAD INCREASED. ANTICOAGULATION PARAMETERS WERE INCREASED, THIS DID NOT CORRECT THE ISSUE. ANOTHER EFFORT WAS MADE TO CORRECT THE THROMBOSIS WITH INTEGRILIN, DID NOT CORRECT THE ISSUE. TRANSFER TO HOSPICE ON (B)(6) 2013." THE PT EXPIRED ON (B)(6) 2013.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION: FOLLOW-UP INFORMATION OBTAINED FROM THE CENTER INDICATED THAT THE PATIENT HAD BEEN PLACED ON EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) PRIOR TO THE LVAD IMPLANT. THE PATIENT'S WHITE BLOOD CELL (WBC) COUNT WAS ELEVATED. COUMADIN COULD NOT BE INITIATED AS THE PATIENT WAS INTUBATED; HOWEVER, HEPARIN AND ASPIRIN (ASA 325MG) WERE ADMINISTERED WITH A PARTIAL THROMBOPLASTIN TIME (PTT) GOAL OF 40-50SEC. THE PATIENT WAS REPORTEDLY NOT A PUMP EXCHANGE CANDIDATE. AT THE TIME THE PATIENT EXPIRED, THE FAMILY DECLINED TO HAVE THE PUMP EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    239186 HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 104911 124665

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Death