BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS

    MDR report key: 2861328 · Received December 5, 2012

    Report

    Report Number
    2916596-2012-01186
    Event Type
    Injury
    Date Received
    December 5, 2012
    Date of Event
    November 6, 2012
    Report Date
    November 9, 2012
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PT REMAINS ONGOING WITH THE NEW LVAD. THE MFR IS ATTEMPTING TO ACQUIRE THE DEVICE FOR FURTHER EVAL. 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 TO THE MFR THROUGH THE DEVICE TRACKING FORM FROM THE HOSPITAL THAT THE PT'S PUMP WAS EXCHANGED. THE REASON NOTED BY THE SURGEON ON THE FORM STATED, "INLET OCCLUSION OF LVAD AS WELL AS OUTFLOW KINK." ADDITIONAL INFO WAS RECEIVED FROM THE VAD COORDINATOR THAT THE PT WAS ADMITTED INTO THE HOSPITAL 12 DAYS PRIOR TO THE PUMP EXCHANGE WITH ELEVATED LFT'S (LIVER FUNCTION TEST), CREATININE, LDH AND PLASMA FREE HEMOGLOBIN. HER SKIN WAS VERY JAUNDICE. THE PT WAS HAVING SMALL AMOUNTS OF BLOODY EMESIS FOR 3 DAYS, BUT DID NOT REPORT IT TO THE VAD COORDINATOR UNTIL THE THIRD DAY. THE PT WAS ADMINISTERED ANTICOAGULATION MEDICATION UNTIL HER PUMP WAS EXCHANGED. THE PT'S ELEVATED LABS SLOWLY NORMALIZED BEFORE SURGERY. THE PT'S PUMP WAS EXCHANGED WITH ANOTHER LVAD. THE VAD COORDINATOR ALSO REPORTED THAT PRIOR TO THE PT'S PUMP EXCHANGE (POST INITIAL IMPLANT OF THE PUMP) THE PT WAS VERY STABLE AFTER SHE WAS DISCHARGED TO HOME. THE PT HAD GONE BACK TO WORK AND HAD NO COMPLAINTS. IT WAS REPORTED THAT NO MEDICATIONS WOULD HAVE INTERFERED WITH HER TREATMENT. SHE WAS BRIDGED ON BIVALIRUDIN POST IMPLANTATION OF HER PRIMARY PUMP. IT WAS REPORTED THAT "SHE LOOKED LIKE A GEM IN CLINIC."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTMATE II LVAS DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 104911 110286

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention