BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE II LVAS

    MDR report key: 3911508 · Received May 28, 2014

    Report

    Report Number
    2916596-2014-00849
    Event Type
    Death
    Date Received
    May 28, 2014
    Date of Event
    April 5, 2014
    Report Date
    April 28, 2014
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE INFORMATION AVAILABLE TO THE MANUFACTURER, A CORRELATION BETWEEN THE DEVICE AND THE EVENT CANNOT BE CONCLUSIVELY DETERMINED. HOWEVER, INFORMATION PROVIDED TO THE MANUFACTURER INDICATED THAT LVAD SUPPORT WAS WITHDRAWN DUE TO TRACHEOSTOMY BLEEDING. A REVIEW OF DEVICE HISTORY RECORDS SHOWED NO DEVIATIONS FROM MANUFACTURING OR QA SPECIFICATIONS. NO FURTHER INFORMATION IS AVAILABLE. THE MANUFACTURER IS CLOSING ITS FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 1

    THE PUMP WILL NOT BE RETURNING TO THE MFR FOR EVAL, AS IT WAS NOT EXPLANTED. THROUGHOUT THE PT'S REPORTED COMPLICATED POSTOPERATIVE COURSE THERE WERE NO REPORTS OF ANY ISSUES WITH THE LVAD OR ACCESSORIES. NO FURTHER INFO IS AVAILABLE AT THIS TIME. 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 (LVAD). IT WAS REPORTED BY THE VAD ADMINISTRATOR THAT PRIOR TO IMPLANT, THE PT WAS ADMITTED FROM AN OUTSIDE HOSPITAL FOR CARDIOGENIC SHOCK, AND AN INTRA-AORTIC BALLOON (IABP) PUMP WAS PLACED. LVAD AND RVAD/ECMO SUPPORT WERE PLACED ON (B)(6) 2014. ECMO WAS WEANED AND DISCONTINUED ON (B)(6) 2014. THE IABP WAS DISCONTINUED ON (B)(6) 2014. ON (B)(6) 2014, THE PT WAS STARTED ON SLOW CONTINUOUS ULTRAFILTRATION. ON (B)(6) 2014, THE PT EXPERIENCED BLEEDING FROM THE MOUTH AND AROUND THE TRACHEOSTOMY. THE FOLLOWING MORNING THE PT BECAME UNRESPONSIVE WITH ABSENT PULSES AND RESPIRATORY ARREST AND WAS RESUSCITATED WITH MULTIPLE UNITS OF PACKED RED BLOOD CELLS (PRBC) AND FRESH FROZEN PLASMA (FFP) WITH RETURN OF SPONTANEOUS CIRCULATION (ROSC). A CHEST TUBE WAS INSERTED FOR A RIGHT SIDE PNEUMOTHORAX. PLANS WERE MADE FOR GI TO PERFORM AN URGENT UPPER GI ENDOSCOPY, BUT A FEW HOURS LATER IN THE MORNING THE PT EXPERIENCED ANOTHER CODE. THE PT WAS RESUSCITATED WITH PRBCS, FFP AND PLATELETS WITH SUCCESSFUL RETURN OF SPONTANEOUS CIRCULATION (ROSC). CARE WAS ELECTIVELY WITHDRAWN AFTER DISCUSSION WITH FAMILY MEMBERS AND THE PT WAS PRONOUNCED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION: IT WAS REPORTED THAT THE DEVICE WAS FUNCTIONING AS INTENDED AND THE EVENT WAS NOT DEVICE RELATED. THE PUMP IS NOT AVAILABLE FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    313548 HEARTMATE II LVAS DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 106015 138083

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Death