BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTWARE® VENTRICULAR ASSIST SYSTEM

    MDR report key: 6165768 · Received December 12, 2016

    Report

    Report Number
    3007042319-2016-04352
    Event Type
    Death
    Date Received
    December 12, 2016
    Date of Event
    December 1, 2016
    Report Date
    December 1, 2016
    Manufacturer
    HEARTWARE, INC
    Product Code
    DSQ
    PMA / PMN Number
    P100047
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WITH REVIEW OF THE AVAILABLE INFORMATION THERE IS NO INDICATION OF ANY DEVICE MALFUNCTION OR PERFORMANCE ISSUES IMPACTING THE EVENT. ALTHOUGH A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED, CLINICAL, PHARMACOLOGICAL, AND PATIENT FACTORS INCLUDING COMORBIDITIES ARE KNOWN POSSIBLE CONTRIBUTORS TO THE EVENT. 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. THE IMPLANTATION OF A VAD IS AN INVASIVE PROCEDURE REQUIRING GENERAL ANESTHESIA, MEDIAN STERNOTOMY, A VENTILATOR AND CARDIOPULMONARY BYPASS. A USER MUST FULLY CONSIDER THE RISKS OF THIS DEVICE WITH THAT OF OTHER TREATMENT MODALITIES BEFORE DECIDING TO PROCEED WITH DEVICE IMPLANTATION. THESE SURGICAL PROCEDURES ARE ASSOCIATED WITH NUMEROUS RISKS. DEATH IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH THE IMPLANTATION OF ALL VADS AS OUTLINED IN THE INSTRUCTIONS FOR USE. RIGHT HEART FAILURE IS KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH THE IMPLANTATION OF ALL VADS AS OUTLINED IN THE INSTRUCTIONS FOR USE (IFU). DEVICE REMAINS IMPLANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED FROM THE SITE BY THE PERFUSIONIST THAT THE, PATIENT WAS IMPLANTED ON (B)(6) 2016 AND WAS TRANSITIONED FROM C-MAG AND EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) TO HVAD. THE PATIENT DID NOT NEED RIGHT VENTRICULAR (RV) SUPPORT AT THE END OF THE CASE. DURING THE PATIENT'S POST-OPERATIVE COURSE, SHE DID NOT THRIVE. HER RV CONTINUED TO DECOMPENSATE AND SHE EXPIRED ON (B)(6) 2016. PATIENT EXPIRED ON (B)(6) 2016 WITH A CAUSE OF DEATH TO BE RV FAILURE. SITE DOES NOT BELIEVE THAT IT IS RELATED TO THE PUMP. FAMILY DENIED AN AUTOPSY, SO THE PUMP WILL NOT BE SENT BACK. THE SITE WILL BE DISPOSING OF THE PERIPHERALS. NO ADDITIONAL INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    816971 HEARTWARE® VENTRICULAR ASSIST SYSTEM CIRCULATORY ASSIST SYSTEM, BATTERY DSQ HEARTWARE, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Death