BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTWARE® VENTRICULAR ASSIST SYSTEM

    MDR report key: 3942310 · Received July 17, 2014

    Report

    Report Number
    3007042319-2014-00742
    Event Type
    Injury
    Date Received
    July 17, 2014
    Date of Event
    March 17, 2014
    Report Date
    June 17, 2014
    Manufacturer
    HEARTWARE, INC
    Product Code
    DSQ
    PMA / PMN Number
    P100047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE HVAD IS USED FOR TREATMENT NOT DIAGNOSIS. IT WAS REPORTED A PATIENT WAS ADMITTED TO HOSPITAL WITH ABDOMINAL PAIN AND DIAGNOSED WITH A DRIVELINE EXIT SITE INFECTION. SURGICAL EXPLORATION WITH WASHOUT WAS PERFORMED AND VACUUM-ASSISTED CLOSURE DRESSING WAS APPLIED. IT WAS REPORTED THE PATIENT WAS PRESCRIBED ANTIBIOTICS FOR FURTHER COVERAGE. THE PATIENT WAS DISCHARGED HOME ON CONTINUED ORAL ANTIBIOTICS. THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION AS IT REMAINS IMPLANTED. DRIVELINE SITE INFECTION IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH THE USE OF ALL VADS AS OUTLINED IN THE INSTRUCTIONS FOR USE (IFU). THE IFU AND PATIENT MANUAL ADDRESSES GUIDELINES FOR OPTIMAL PATIENT MANAGEMENT INCLUDING PRE AND POST-OPERATIVE INFECTION CONTROL MEASURES AND DRIVELINE CARE. ALTHOUGH A DEFINITIVE CONCLUSION CANNOT BE MADE REGARDING THE ROOT CAUSE OF THE REPORTED INFECTION, PATIENT FACTORS INCLUDING DRIVELINE EXIT SITE MANAGEMENT AND PATIENT COMORBIDITIES MAY INCREASE THE RISK OF INFECTION; WITH NO INDICATION OF ANY DEVICE MALFUNCTIONS OR PERFORMANCE ISSUES. THE VENTRICULAR ASSIST SYSTEM IS INDICATED FOR USE AS A BRIDGE TO CARDIAC TRANSPLANTATION IN PATIENTS WHO ARE AT RISK OF DEATH FROM REFRACTORY END-STAGE LEFT VENTRICULAR HEART FAILURE. THE SYSTEM IS DESIGNED FOR IN-HOSPITAL AND OUT-OF-HOSPITAL SETTINGS. HEARTWARE WILL SUBMIT A SUPPLEMENTAL REPORT WHEN NEW FACTS ARISES WHICH MATERIALLY ALTERS INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT. HEARTWARE IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER FLA-14-14, DATED JUNE 2, 2014, AND PURSUANT TO THE PROVISIONS OF 21 CFR PART 803.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN THIRTY (30) DAYS OF RECEIPT. DEVICE REMAINS IMPLANTED.

    Description of Event or Problem · 1

    APPROXIMATELY SIX MONTHS AFTER IMPLANT, THIS PATIENT WAS ADMITTED TO HOSPITAL WITH ABDOMINAL PAIN AND DIAGNOSED WITH A DRIVELINE EXIT SITE INFECTION. TREATMENT INCLUDED SURGICAL EXPLORATION WITH WASHOUT, APPLICATION OF A VACUUM-ASSISTED CLOSURE DRESSING AND ANTIBIOTICS. THEY WERE LATER DISCHARGED HOME ON ORAL ANTIBIOTICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    418918 HEARTWARE® VENTRICULAR ASSIST SYSTEM CIRCULATORY ASSIST SYSTEM DSQ HEARTWARE, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R