BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTWARE® VENTRICULAR ASSIST SYSTEM

    MDR report key: 6042336 · Received October 19, 2016

    Report

    Report Number
    3007042319-2016-03656
    Event Type
    Death
    Date Received
    October 19, 2016
    Date of Event
    June 6, 2016
    Report Date
    June 17, 2016
    Manufacturer
    HEARTWARE, INC
    Product Code
    DSQ
    PMA / PMN Number
    P100047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WITH A REVIEW OF THE AVAILABLE INFORMATION THERE IS NO EVIDENCE TO INDICATE ANY DEVICE MALFUNCTIONS OR PERFORMANCE ISSUES THAT WOULD IMPACT THE REPORTED EVENT. THERE IS ALSO NO CLINICAL EVIDENCE TO SUGGEST THAT THE DEVICE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THOUGH A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED, THE MOST LIKELY ROOT CAUSE OF THE REPORTED EVENT AND PATIENT OUTCOME (DEATH) IS RELATED TO THE PATIENT'S ONGOING HISTORY OF NON-COMPLIANCE. IN ADDITION, CLINICAL FACTORS THAT MAY HAVE ALSO CONTRIBUTED INCLUDE THE PATIENT'S PRE-EXISTING CONDITIONS, PROGRESSION OF DISEASE, AND RELATED PATIENT COMORBIDITIES. THERE ARE PATIENT FACTORS THAT MAY HAVE CONTRIBUTED TO THIS EVENT. THE SYSTEM IS DESIGNED TO ASSIST A WEAKENED, POORLY FUNCTIONING LEFT VENTRICLE. THE IMPLANTATION OF A VAD IS AN INVASIVE PROCEDURE REQUIRING GENERAL ANESTHESIA, MEDIAN STERNOTOMY, A VENTILATOR AND CARDIOPULMONARY BYPASS. THESE SURGICAL PROCEDURES ARE ASSOCIATED WITH NUMEROUS RISKS. RESPIRATORY FAILURE AND SEPTIC SHOCK ARE KNOWN POTENTIAL COMPLICATIONS ASSOCIATED WITH ALL PATIENTS IMPLANTED WITH VAD'S. THE INSTRUCTIONS FOR USE (IFU) AND PATIENT MANUEL ADDRESSES GUIDELINES FOR OPTIMAL PATIENT MANAGEMENT. RIGHT HEART FAILURE IS A POTENTIAL EVENT THAT MAY BE ASSOCIATED WITH USE OF THE PRODUCT. RIGHT HEART FAILURE USUALLY DEVELOPS WITHIN THE FIRST 24 HOURS AFTER LVAD IMPLANT. THE IFU PROVIDES GUIDELINES ON MANAGEMENT OF RIGHT HEART FAILURE. PATIENTS IMPLANTED WITH VAD'S OFTEN HAVE PREEXISTING CONDITIONS THAT MAY EXACERBATE RIGHT HEART FAILURE. 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. RIGHT OUTLINED IN THE INSTRUCTIONS FOR USE (IFU). WITH REVIEW OF THE AVAILABLE INFORMATION THERE IS NO INDICATION OF ANY RELATED DEVICE MALFUNCTIONS OR PERFORMANCE ISSUES. ALTHOUGH THE ETIOLOGY OF THE RIGHT HEART FAILURE AND RELATIONSHIP TO THE DEVICE AND PROCEDURE CANNOT BE DETERMINED, IT MAY BE A PROGRESSION OF CHRONIC HEART DISEASE, CORONARY ARTERY DISEASE OR RIGHT VENTRICULAR INFARCTION. THE IFU ADDRESSES GUIDELINES FOR OPTIMAL PATIENT MANAGEMENT. 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

    IT WAS REPORTED FROM THE CLINICAL ENGINEER THAT THIS PATIENT WAS ADMITTED TO THE HOSPITAL FOR TREATMENT OF RIGHT VENTRICULAR FAILURE AFTER COMPLAINING OF SHORTNESS OF BREATH AND 15 POUND WEIGHT GAIN OVER THE PAST COUPLE WEEKS. THE PATIENT RECEIVED AGGRESSIVE DIURESIS VIA MILRINONE AND LASIX. HE WAS REPORTED TO BE NONCOMPLIANT WITH IN THE PAST. TRANSTHORACIC ECHOCARDIOGRAM RESULTS CONFIRMED WORSENING RIGHT VENTRICULAR FAILURE. THE PATIENT WAS FOLLOWED BY PALLIATIVE CARE TO DISCUSS WISHES UNTIL HIS DISCHARGE ON (B)(6) 2016. AT THE TIME OF DISCHARGE THE PATIENT WAS DIURESED 15 LBS., BACK TO HIS BASELINE WEIGHT. AT CLINIC VISIT ON (B)(6) 2016 THE PATIENT WAS REPORTED TO BE STABLE WITHOUT WEIGHT GAIN; HOWEVER, AT SOME POINT THE PATIENT AGAIN BEGAN TO REFUSE INOTROPIC TREATMENT. HE WAS PLACED INTO HOSPICE CARE AND REPORTEDLY EXPIRED ON (B)(6) 2016. THE CAUSE OF DEATH WAS LISTED AS RIGHT VENTRICULAR FAILURE AND WAS NOT CONSIDERED TO BE DEVICE RELATED. ALL PERIPHERAL EQUIPMENT WAS DISPOSED BY THE SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    691026 HEARTWARE® VENTRICULAR ASSIST SYSTEM CIRCULATORY ASSIST SYSTEM DSQ HEARTWARE, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Death