BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE II LVAD

    MDR report key: 3111108 · Received May 9, 2013

    Report

    Report Number
    2916596-2013-00553
    Event Type
    Death
    Date Received
    May 9, 2013
    Date of Event
    March 7, 2013
    Report Date
    April 11, 2013
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A DIRECT CORRELATION BETWEEN THE EVENT AND THE DEVICE COULD NOT BE CONCLUSIVELY DETERMINED. THE CENTER DID NOT REPORT ANY SPECIFIC DEVICE-RELATED ISSUES. AN AUTOPSY WAS NOT PERFORMED AND THE PUMP WAS NOT EXPLANTED. A REVIEW OF DEVICE HISTORY RECORDS SHOWED NO DEVIATIONS FROM MANUFACTURING OR QA SPECIFICATIONS. BASED ON THE INFORMATION AVAILABLE AND DUE TO THE DEVICE NOT BEING AVAILABLE FOR ANALYSIS, NO CONCLUSION CAN BE DRAWN AS TO THE CAUSE OF THE REPORTED EVENT. NO FURTHER INFORMATION IS AVAILABLE. THE MANUFACTURER IS CLOSING ITS FILE ON THIS EVENT. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER IS ATTEMPTING TO ACQUIRE THE DEVICE FOR FURTHER 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 WAS READMITTED FOR HEART FAILURE. THE PT WAS MONITORED IN HOSPITAL SETTING AND DISCHARGED AFTER HEART FAILURE SYMPTOMS WERE RELIEVED. ADDITIONAL INFORMATION PROVIDED STATED THAT THE PT WAS ADMITTED WITH CONGESTIVE HEART FAILURE (CHF) EXACERBATION AND SHORTNESS OF BREATH (SOB). AT THE TIME OF ADMISSION, HE CAME FROM ANOTHER HOSPITAL'S EMERGENCY ROOM AND WAS MORE HYPOTENSIVE 68/DOPPLER, ON A NON-RE BREATHER AND WHITE BLOOD CELL COUNT OF 20. HE WAS FOUND TO HAVE PNEUMONIA AND POSSIBLE PAROTID GLAND INFECTION. HE WAS PLACED ON INTRAVENOUS LASIX AND CONTINUED INTRAVENOUS MILRINONE. HE WAS GIVEN INTRAVENOUS ANTIBIOTICS OVER THE WEEKEND, BUT DECOMPENSATED AND WAS PLACED IN THE INTENSIVE CARE UNIT AFTER HAVING POOR OXYGENATION AND WAS HEMODYNAMICALLY UNSTABLE. AFTER MEETING WITH PALLIATIVE CARE TEAM A DECISION WAS MADE TO MAKE HIM LET (LIKE DNR). ON ADMISSION, IT WAS DISCUSSED WITH THE FAMILY THAT HE WAS NOT THRIVING AND ACTUALLY PROGRESSIVELY GETTING WEAKER WITH HIS HEART FAILING. WITH THE INFECTION, HIS BODY WAS NOT ABLE TO TOLERATE EVERYTHING AND DUE TO HIS DECLINE, THE FAMILY DECIDED TO WITHDRAW CARE. THE PT EXPIRED ON APRIL 15, 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204896 HEARTMATE II LVAD DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORPORATION 104911 115863

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Death