BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE

    MDR report key: 3945654 · Received July 7, 2014

    Report

    Report Number
    2916596-2014-00981
    Event Type
    Death
    Date Received
    July 7, 2014
    Date of Event
    February 6, 2014
    Report Date
    June 5, 2014
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT EXPIRED AND THE PUMP WAS NOT EXPLANTED. REFERENCE MFR 2916596-2013-00364 FOR THE PATIENT'S FEVER AND DRIVELINE INFECTION. A ROOT CAUSE FOR THE REPORTED EVENT COULD NOT CONCLUSIVELY BE DETERMINED THROUGH THIS EVALUATION. IT WAS COMMUNICATED THAT THE PATIENT SUFFERED A CEREBELLAR HEMORRHAGE AND SUBSEQUENTLY DEVELOPED WORSENING RENAL FAILURE THAT WAS THOUGHT TO BE RELATED TO THE ANTIBIOTICS REQUIRED TO TREAT HIS PSEUDOMONAS INFECTION. THE PATIENT'S FAMILY ULTIMATELY MADE THE DECISION TO WITHDRAW CARE AND THE PATIENT EXPIRED ON (B)(6) 2014. A FULL EVALUATION OF VAD-7198 COULD NOT BE CONDUCTED BECAUSE THE SYSTEM WAS NOT RETURNED FOR ANALYSIS. A REVIEW OF DEVICE HISTORY RECORDS FOR THIS DEVICE SHOWED NO DEVIATIONS FROM MANUFACTURING OR QA SPECIFICATIONS. NO FURTHER INFORMATION IS AVAILABLE. THE MANUFACTURER IS CLOSING ITS FILE ON THIS EVENT.

    Description of Event or Problem · 1

    THE PATIENT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE. THE VAD COORDINATOR REPORTED: PATIENT WAS READMITTED TO THE HOSPITAL ON (B)(6) 2014, FOR DETERIORATION IN HIS CONSCIOUSNESS AS HE HAD BEEN UNRESPONSIVE. A CT SCAN OF THE HEAD REVEALED CEREBELLAR HEMORRHAGE AND HIS INR WAS ABOVE 5.0 AT THAT POINT. THE PATIENT'S INR WAS REVERSED WITH FFP. HIS COUMADIN WAS WITHHELD AND NEURO/STROKE AND NEUROSURGERY WERE CONSULTED AS WELL AS INFECTIOUS DISEASE RECONSULTED FOR HIS STROKE AND PSEUDOMONAS INFECTION RESPECTIVELY. FOLLOW-UP CT SCANS WERE PERFORMED FOR HIS HEAD WHICH REVEALED THAT THE HEMORRHAGE WAS NOT WORSENING AND THAT THE CEREBELLAR EDEMA WAS STABLE; HOWEVER, THE PATIENT'S ANTIBIOTICS WERE ADJUSTED TO COVER HIS MULTIDRUG-RESISTANT BACTERIA. THE PATIENT STATED TO DEVELOP WORSENING RENAL FAILURE WHICH WAS THOUGH TO BE LIKELY DUE TO HIS ANTIBIOTICS. PALLIATIVE CARE WAS ALSO CONSULTED AND THE DOCTOR SAW THE PATIENT AND PATIENT WAS INITIALLY MADE A DNR WITH PERMISSION OF BOTH PARENTS; HOWEVER, A FEW DAYS LATER THE PATIENT CONTINUED TO DETERIORATE. HIS CREATININE CONTINUED TO WORSEN AND DISCUSSIONS WITH THE FAMILY LEAD TO A FINAL DECISION OF WITHHOLDING CARE. VAD SUPPORT WAS TURNED OFF AND THE PATIENT EXPIRED 30 MINUTES LATER. THE PATIENT EXPIRED ON (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    393192 HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORPORATION 103695 89207

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Death