BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTWARE® VENTRICULAR ASSIST SYSTEM

    MDR report key: 6560713 · Received May 11, 2017

    Report

    Report Number
    3007042319-2017-01437
    Event Type
    Injury
    Date Received
    May 11, 2017
    Date of Event
    April 12, 2017
    Report Date
    April 14, 2017
    Manufacturer
    HEARTWARE
    Product Code
    DSQ
    PMA / PMN Number
    P100047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR TREATMENT NOT DIAGNOSIS. 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. DRIVELINE INFECTION IS A POTENTIAL EVENT THAT MAY BE ASSOCIATED WITH USE OF THE PRODUCT. THE INSTRUCTIONS FOR USE (IFU) PROVIDES GUIDELINES TO REDUCE THE OCCURRENCE AND SEVERITY OF INFECTION. THOSE WITH COMPROMISED IMMUNE SYSTEMS AND/OR TREATED WITH MULTIPLE ANTIBIOTICS ARE MORE SUSCEPTIBLE TO THESE TYPES OF INFECTIONS. OTHER CONTRIBUTING FACTORS CAN ALSO INCLUDE THE PATIENT'S BODY TYPE AND NUTRITIONAL STATUS, PLACEMENT, POSITION AND SIZE OF THE VAD, TENSION/ TRAUMA TO THE DRIVELINE EXIT SITE, AND DURATION OF TIME ON VAD SUPPORT. THE DEVICE REMAINS IMPLANTED IN THE PATIENT AND IS THUS NOT AVAILABLE FOR RETURN TO THE MANUFACTURER. BASED ON THE AVAILABLE INFORMATION THERE IS NO EVIDENCE TO INDICATE ANY DEVICE MALFUNCTIONS OR PERFORMANCE ISSUES OF THE DEVICE THAT WOULD IMPACT THE REPORTED EVENT. THERE IS ALSO NO EVIDENCE TO SUGGEST THAT THE DEVICE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. A DEFINITIVE ROOT CAUSE CANNOT BE CONCLUSIVELY DETERMINED. CLINICAL FACTORS THAT MAY HAVE CONTRIBUTED TO THE PATIENT'S OUTCOME CAN BE MULTIFACTORIAL AND MAY BE ATTRIBUTED TO MEDICAL TREATMENT, PROGRESSION OF DISEASE AND THE PATIENT'S RELATED COMORBIDITIES. THERE ARE PATIENT, PROCEDURAL, AND PHARMACOLOGICAL FACTORS THAT MAY HAVE CONTRIBUTED TO THIS EVENT. HEARTWARE WILL SUBMIT A SUPPLEMENTAL REPORT WHEN NEW FACTS ARISES WHICH MATERIALLY ALTERS INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT. DEVICE REMAINS IMPLANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS HOSPITALIZED WITH SEROUS DRAINAGE FROM THE VENTRICULAR ASSIST DEVICE (VAD) DRIVELINE SITE. WHITE BLOOD CELL COUNT: 11,000/MM3; C-REACTIVE PROTEIN: 109. BLOOD AND DRIVELINE SITE CULTURES WERE TAKEN. BLOOD CULTURES WERE POSITIVE FOR PYOCYANIQUE BACILLUS. THE PATIENT WAS TREATED WITH INTRAVENOUS ANTIBIOTICS. THE VAD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    341907 HEARTWARE® VENTRICULAR ASSIST SYSTEM CIRCULATORY ASSIST SYSTEM DSQ HEARTWARE

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R