BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTWARE® VENTRICULAR ASSIST SYSTEM

    MDR report key: 4920393 · Received July 16, 2015

    Report

    Report Number
    3007042319-2015-01486
    Event Type
    Injury
    Date Received
    July 16, 2015
    Date of Event
    June 1, 2015
    Report Date
    June 16, 2015
    Manufacturer
    HEARTWARE, INC
    Product Code
    DSQ
    PMA / PMN Number
    P100047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT WAS NOTED WITH REVIEW OF LESICKA, A. MD ET AL, "ECHOCARDIOGRAPHIC ARTIFACT INDUCED BY HEARTWARE LEFT VENTRICULAR ASSIST DEVICE", ANESTHESIA AND ANALGESIA, 2015 JUN; 120(6); 1208-11. 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. IMPLANTATION OF A VENTRICULAR ASSIST DEVICE (VAD) IS AN INVASIVE PROCEDURE REQUIRING GENERAL ANESTHESIA, A MEDIAN STERNOTOMY, A VENTILATOR AND CARDIOPULMONARY BYPASS. THESE SURGICAL PROCEDURES AND THE USE OF THE DEVICE ARE ASSOCIATED WITH NUMEROUS RISKS. RIGHT HEART FAILURE IS KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH THE IMPLANTATION OF ALL VADS AS OUTLINED IN THE INSTRUCTIONS FOR USE (IFU) AND TYPICALLY DEVELOPS WITHIN THE FIRST 24 HOURS AFTER LVAD IMPLANTATION. THE IFU ADDRESSES GUIDELINES FOR OPTIMAL PATIENT MANAGEMENT. THE ROOT CAUSE OF THE RIGHT VENTRICULAR FAILURE CANNOT BE DETERMINED; HOWEVER, CLINICAL AND PATIENT FACTORS INCLUDING COMORBIDITIES INCLUDING PRE-EXISTING TRICUSPID DISEASE ARE POSSIBLE CONTRIBUTORS TO THE EVENT. THERE IS NO EVIDENCE TO SUGGEST A RELATIONSHIP TO ANY DEVICE PERFORMANCE OR MANUFACTURING ISSUES. HEARTWARE WILL SUBMIT A SUPPLEMENTAL REPORT WHEN NEW FACTS ARISES WHICH MATERIALLY ALTERS INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT.

    Description of Event or Problem · 1

    WITH REVIEW OF PUBLISHED ARTICLE FROM ANESTHESIA AND ANALGESIA, WHICH DISCUSSES DEVICE INDUCED ECHOCARDIOGRAPHIC ARTIFACT, A CASE REPORT IS PRESENTED IN WHICH A RIGHT VENTRICULAR ASSIST DEVICE WAS REQUIRED FOR SUPPORT AFTER PLACEMENT OF THE LEFT VENTRICULAR ASSIST DEVICE (LVAD). THE PATIENT UNDERWENT IMPLANTATION OF THE LVAD AS A BRIDGE TO HEART TRANSPLANTATION. THE LVAD WAS IMPLANTED AND A TRICUSPID ANNULOPLASTY WAS PERFORMED. AFTER BYPASS, 2-DIMENSIONAL TEE IMAGING REVEALED PROPER INFLOW CANNULA ORIENTATION AT THE LEFT VENTRICULAR APEX WITH NO EVIDENCE OF OBSTRUCTION. COLOR DOPPLER, HOWEVER, REVEALED A CONTINUOUS ARTIFACT THAT EXTENDED THE LENGTH OF THE COLOR SECTOR, FROM THE LVAD INFLOW CANNULA TOWARD THE ORIGIN OF THE IMAGING SECTOR. THE USE OF SPECTRAL DOPPLER WITH BOTH PULSED WAVE AND CONTINUOUS WAVE (CW) DEMONSTRATED AN ARTIFACT THAT PRECLUDED INTERROGATION OF THE INFLOW CANNULA VELOCITIES THE ALIGNMENT OF THE IMPELLER AND THE ASSOCIATED ARTIFACT WITH THE COAPTATION POINT OF THE MITRAL VALVE MADE EVALUATION OF THE MITRAL VALVE CHALLENGING. UNOBSTRUCTED LAMINAR FLOW WAS SEEN AT THE SITE OF THE OUTFLOW GRAFT ANASTOMOSIS IN THE ASCENDING AORTA. DESPITE LVAD IMPLANTATION AND TRICUSPID VALVE ANNULOPLASTY, THE RIGHT VENTRICLE BECAME DILATED, AND THE TRICUSPID VALVE REGURGITATION REMAINED MODERATE TO SEVERE. THE TRICUSPID VALVE WAS THEN REPLACED, AND A RIGHT VENTRICULAR ASSIST DEVICE WAS PLACED FOR SUPPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    462093 HEARTWARE® VENTRICULAR ASSIST SYSTEM CIRCULATORY ASSIST SYSTEM DSQ HEARTWARE, INC

    Patients

    Seq Age Sex Outcome Treatment
    1