BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE II LVAS

    MDR report key: 3775414 · Received April 22, 2014

    Report

    Report Number
    2916596-2014-00619
    Event Type
    Death
    Date Received
    April 22, 2014
    Date of Event
    December 3, 2012
    Report Date
    March 25, 2014
    Manufacturer
    THORATEC CORP
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE INFORMATION AVAILABLE TO THE MANUFACTURER, THERE WERE NO LVAD RELATED ISSUES REPORTED AND A CORRELATION BETWEEN THE DEVICE AND THE PATIENT'S EXPIRATION COULD NOT CONCLUSIVELY BE DETERMINED. THE PUMP WAS REPORTEDLY DISPOSED OF AND IS NOT AVAILABLE FOR INVESTIGATION. 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 MANUFACTURER WAS ADVISED THAT THE EXPLANTED LVAD PUMP WILL NOT BE RETURNING FOR EVALUATION. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'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 COORDINATOR THAT THE PT EXPIRED. AS PREVIOUSLY REPORTED, THE PT HAD EXPERIENCED DEVICE THROMBOSIS, WAS TREATED AND SENT HOME (REFERENCE MEDWATCH 2916596-2012-01261). APPROXIMATELY 9 MONTHS LATER, THE PT UNDERWENT A PUMP EXCHANGE DUE TO RESISTANT SERRATIA PERCUTANEOUS LEAD INFECTION ( REFERENCE MEDWATCH 2916596-2012-1195). THE PT EXPIRED ON (B)(6) 2012. THE PT HAD BEEN SHORT OF BREATH AND FATIGUED FOR SEVERAL DAYS AFTER DISCHARGE FROM THE HOSPITAL FOR REOCCURRING SEIZURE. THE EMERGENCY SERVICES WAS CALLED FOR DIMINISHED RESPONSIVENESS AND QUESTIONABLE REOCCURRING SEIZURE. IN ROUTE THE PT WAS ASSESSED AND WAS NOT PERFUSING (NO PULSE AND COOL), CARDIOPULMONARY RESUSCITATION WAS INITIATED AND ONE SHOCK GIVEN EXTERNALLY. ON ARRIVAL TO THE EMERGENCY ROOM THE PT WAS UNRESPONSIVE WITH FIXED AND DILATED PUPILS. THE HOSPITAL REPORTS A POSSIBLE CORRELATION BETWEEN THE SEIZURES AND PUMP CLOT AS SHE HAD THE SEIZURES AFTER HER STROKE WHICH OCCURRED AFTER THE PUMP THROMBUS. ADDITIONALLY, THE ICD WAS INTERROGATED AND THOUGHT TO HAVE NOT FIRED FOR THE V-FIB DUE TO SEVERE ACIDOSIS. IT WAS NOTED THAT THE PUMP WAS NOT ALARMING FOR LOW FLOW WITH THE RED HEART ALARM. THE FAMILY WAS NOT ABLE TO SUPPLY ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    244618 HEARTMATE II LVAS DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP 104911 118140

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Death