BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS

    MDR report key: 4162685 · Received October 7, 2014

    Report

    Report Number
    2916596-2014-01792
    Event Type
    Injury
    Date Received
    October 7, 2014
    Date of Event
    September 6, 2014
    Report Date
    September 10, 2014
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PT CONTINUES ON LVAD SUPPORT WITH NO FURTHER ISSUE REPORTED. NO FURTHER INFO IS AVAILABLE AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETED.

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER WAS UNABLE TO CONDUCT AN INVESTIGATION OF THE DEVICE AS THE PATIENT REMAINS ONGOING ON THE IMPLANTED LVAD. BASED ON THE INFORMATION AVAILABLE TO THE MANUFACTURER, A CORRELATION BETWEEN THE DEVICE AND THE REPORTED EVENT COULD NOT CONCLUSIVELY BE DETERMINED; HOWEVER, DRIVELINE INFECTION IS LISTED IN THE DEVICE¿S APPROVED LABELING AS AN ADVERSE EVENT THAT MAY BE ASSOCIATED WITH THE USE OF THE LEFT VENTRICULAR ASSIST SYSTEM (LVAS). A REVIEW OF THE DEVICE HISTORY RECORDS REVEALED THE PUMP MET ALL APPLICABLE SPECIFICATIONS UPON PRODUCT RELEASE. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. THE MANUFACTURER IS CLOSING ITS FILE ON THIS EVENT.

    Description of Event or Problem · 1

    THE PT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE. IT WAS REPORTED THAT THE PT HAD TWO LOW GRADE FEVERS ON (B)(6) 2014 WITH COMPLAINTS OF PAIN THAT DIFFUSED FROM THE CHIN TO GROIN AREA. THE PT WAS READMITTED ON (B)(6) 2014 DUE TO AN ABSCESS POCKET NOTED AROUND THE OUTFLOW TRACK THAT WAS CLOSE TO THE PUMP POCKET WHICH STARTED TO DRAIN PURULENT FLUID. THE PT WAS STARTED ON IV ANTIBIOTICS. THE DRIVELINE EXIT SITE WAS CLEAN, DRY AND INTACT. ON (B)(6) 2014, THE PT WAS BROUGHT TO THE OPERATING ROOM FOR SURGICAL DEBRIDEMENT, CONTINUOUS ANTIBIOTIC IRRIGATION WAS INITIATED, 18 VANCOMYCIN BEADS WERE PLACED NEAR OUTFLOW ELBOW/PUMP POCKET AND THE OLD DRIVELINE SITE ALSO DEBRIDED. IT WAS NOTED THAT THE PT WAS A DIABETIC. THE PT WILL BE DISCHARGED WITH A PICC LINE AND IV ANTIBIOTICS. PT HAD LOW GRADE FEVERS X 2 DAYS REPORTED ON (B)(6) 2014. PAIN DIFFUSE FROM CHIN TO GROIN AREA. ADMITTED (B)(6) 2014, ABSCESS POCKED NOTED AROUND OUTFLOW TRACK, CLOSE TO PUMP POCKET WHICH STARTED TO DRAIN PURULENT FLUID. DRIVELINE EXIT SITE CLEAN, DRY, INTACT. ON (B)(6) 2014, THE PT STILL INPATIENT. UNDERGOING WOUND WASHOUTS (FROM STERNUM AND DRIVELINE SITE) 2 TIMES A WEEK SINCE (B)(6) 2014. WOUND VACS APPLIED WITH EACH PROCEDURE. ANTIBIOTIC THERAPY, CONTINUE TO MONITOR.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION: THE PATIENT CONTINUES ON LVAD SUPPORT AND IS BEING MEDICALLY MANAGED ON CHRONIC SUPPRESSIVE ANTIBIOTICS FOR THE ONGOING DRIVELINE INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    629897 HEARTMATE II LVAS DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 106015 135869

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention