BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTWARE VENTRICULAR ASSIST SYSTEM - DRIVELINE

    MDR report key: 7124520 · Received December 18, 2017

    Report

    Report Number
    3007042319-2017-05129
    Event Type
    Injury
    Date Received
    December 18, 2017
    Date of Event
    December 13, 2014
    Report Date
    December 18, 2017
    Manufacturer
    HEARTWARE, INC.
    Product Code
    DSQ
    UDI-DI
    00888707000017
    PMA / PMN Number
    P100047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN

    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 AND DESTINATION THERAPY 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. THE DEVICE REMAINS IMPLANTED IN THE PATIENT AND IS THUS NOT AVAILABLE FOR RETURN TO THE MANUFACTURER. WITH A REVIEW OF THE AVAILABLE INFORMATION THERE IS NO EVIDENCE TO INDICATE ANY DEVICE MALFUNCTIONS OR PERFORMANCE ISSUES THAT WOULD IMPACT THE REPORTED EVENTS. POSSIBLE CLINICAL FACTORS THAT MAY HAVE CONTRIBUTED TO THIS EVENT INCLUDE THE PATIENT¿S PRE-EXISTING HISTORY AND RELATED COMORBIDITIES, THE PROGRESSION OF THEIR UNDERLYING DISEASE, ISSUES RELATED TO THE THERAPEUTIC USE OF ANTICOAGULANT AND ANTIPLATELET MEDICATIONS AND THE PATIENT'S COMPLEX POST-OPERATIVE COURSE. THERE ARE POSSIBLE PATIENT, PHARMACOLOGICAL AND PROCEDURAL FACTORS THAT MAY HAVE CONTRIBUTED TO THIS EVENT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT DEVELOPED A VENTRICULAR ASSIST DEVICE (VAD) DRIVELINE INFECTION. THE PATIENT PRESENTED TO THE HOSPITAL WITH ABDOMINAL PAIN ON (B)(6) 2014. AN ABDOMINAL COMPUTERIZED TOMOGRAPHY (CT) SCAN WAS PERFORMED AND FINDINGS WERE CONSISTENT WITH A DRIVELINE INFECTION. THE PATIENT WAS STARTED ON INTRAVENOUS (IV) ANTIBIOTICS. ON (B)(6) 2014, THE PATIENT WAS TAKEN TO THE OPERATING ROOM FOR EXCISIONAL DEBRIDEMENT OF THE DRIVELINE SITE. THE DRIVELINE WAS STRIPPED OF VELOUR AND WOUND VACUUM ASSISTED CLOSURE (VAC) WAS APPLIED. WOUND AND TISSUE CULTURES WERE OBTAINED IN THE OPERATING ROOM AND WERE (B)(6) FOR (B)(6). THE PATIENT WAS DISCHARGED ON (B)(6) 2014 AND REMAINED ON IV ANTIBIOTICS FOR A SIX-WEEK COURSE. THE PATIENT IS A PARTICIPANT IN THE VENTRICULAR ASSIST DEVICE (VAD) DESTINATION THERAPY TRIAL IMPROVED BLOOD PRESSURE MANAGEMENT CLINICAL STUDY. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    905222 HEARTWARE VENTRICULAR ASSIST SYSTEM - DRIVELINE VENTRICULAR (ASSISST) BYPASS DSQ HEARTWARE, INC. 1103 00888707000017

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization| R