BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTWARE® VENTRICULAR ASSIST SYSTEM

    MDR report key: 3802916 · Received May 9, 2014

    Report

    Report Number
    3007042319-2014-00431
    Event Type
    Injury
    Date Received
    May 9, 2014
    Date of Event
    May 31, 2013
    Report Date
    April 9, 2014
    Manufacturer
    HEARTWARE, INC
    Product Code
    DSQ
    PMA / PMN Number
    P100047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE HVAD IS USED FOR TREATMENT NOT DIAGNOSIS. IT WAS REPORTED THAT A MALE PATIENT DEVELOPED BACTEREMIA. THE PATIENT COMPLAINED OF A BLISTER AND SCAB AT THE DRIVELINE EXIT SITE. A PICC LINE WAS PLACED AND THE PATIENT WAS PRESCRIBED A FIVE WEEK INTRAVENOUS ANTIBIOTIC COURSE. FOLLOW UP BLOOD CULTURES AND CT SCAN WERE NEGATIVE. THE LAST REPORT RECEIVED BY THE SITE INDICATED THAT THE INFECTION HAD RESOLVED COMPLETELY ABOUT SIX WEEKS LATER. THE DEVICE REMAINED IMPLANTED AND WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. DRIVELINE INFECTION AND SEPSIS ARE KNOWN POTENTIAL COMPLICATIONS ASSOCIATED WITH ALL PATIENTS IMPLANTED WITH VADS AS OUTLINED IN THE INSTRUCTIONS FOR USE (IFU). THE IFU ADDRESSES GUIDELINES FOR OPTIMAL PATIENT MANAGEMENT INCLUDING PRE AND POST-OPERATIVE INFECTION CONTROL MEASURES AND DRIVELINE CARE. WITH REVIEW OF THE AVAILABLE INFORMATION, A RELATIONSHIP BETWEEN THE DEVICE AND REPORTED EVENT CANNOT BE DETERMINED. ALTHOUGH A DEFINITIVE ROOT CAUSE AND RELATIONSHIP TO THE DEVICE CANNOT BE DETERMINED, CLINICAL STATUS, COMORBIDITIES, AND PHARMACOLOGICAL FACTORS ARE POSSIBLE CONTRIBUTING FACTORS. 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, INCLUDING TRANSPORTATION. PER THE IFU: ADVERSE EVENTS THAT MAY BE ASSOCIATED WITH THE USE OF VENTRICULAR ASSIST DEVICES, OTHER THAN DEATH, INCLUDE DEVICE THROMBOSIS AND WORSENING HEART FAILURE. 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

    THE PRODUCT REMAINS IMPLANTED IN THE PATIENT, THEREFORE, IT WILL NOT BE RETURNED. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN THIRTY (30) DAYS OF RECEIPT. DEVICE REMAINS IMPLANTED.

    Description of Event or Problem · 1

    APPROXIMATELY EIGHT MONTHS POST HVAD IMPLANTATION, THE PATIENT REPORTEDLY DEVELOPED HIGH GRADE VIRIDINS STREPTOCOCCAL BACTEREMIA. HE REPORTEDLY ALSO COMPLAINED OF A BLISTER AND SCAB AT THE SITE OF HIS DRIVELINE EXIT SITE. THE TREATING PHYSICIAN BELIEVED THAT THE SOURCE OF THE INFECTION HAD LIKELY DERIVED FROM THE GASTROINTESTINAL (GI) TRACT AND SPREAD TO THE HVAD. A PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) LINE WAS PLACED AND THE PATIENT WAS PRESCRIBED A FIVE WEEK INTRAVENOUS ANTIBIOTIC COURSE OF CEFTRIAXONE AND GENTAMYCIN. FOLLOW UP BLOOD CULTURES AND CT SCANS WERE NEGATIVE FOR INFECTION AND FLUID COLLECTION. THE LAST REPORTED RECEIVED BY THE SITE INDICATED THAT THE INFECTION HAD RESOLVED COMPLETELY ABOUT SIX WEEKS LATER. INVESTIGATION IS ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    280318 HEARTWARE® VENTRICULAR ASSIST SYSTEM CIRCULATORY ASSIST SYSTEM DSQ HEARTWARE, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Hospitalization| R