BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTWARE® VENTRICULAR ASSIST SYSTEM

    MDR report key: 6101843 · Received November 15, 2016

    Report

    Report Number
    3007042319-2016-04114
    Event Type
    Death
    Date Received
    November 15, 2016
    Date of Event
    June 23, 2013
    Report Date
    November 7, 2016
    Manufacturer
    HEARTWARE, INC
    Product Code
    DSQ
    PMA / PMN Number
    P100047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    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 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. DEATH AS A POTENTIAL EVENT THAT MAY BE ASSOCIATED WITH USE OF THE PRODUCT. CLINICAL RESULTS AND COMMERCIAL EXPERIENCE DEMONSTRATE THAT THE PLACEMENT OF A VAD IN CHRONIC NYHA CLASS IV PATIENTS IMPROVES SURVIVAL AND QUALITY OF LIFE WHEN COMPARED TO A SIMILAR PATIENT POPULATION RECEIVING CONVENTIONAL THERAPY. FURTHERMORE, THESE BENEFITS APPLY TO PATIENTS BEING BRIDGED TO HEART TRANSPLANT, PATIENTS RECEIVING PERMANENT SUPPORT (DESTINATION THERAPY), AND THOSE BEING SUPPORTED WITH THE EXPECTATION FOR MYOCARDIAL RECOVERY. 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. SERIOUS AND LIFE THREATENING ADVERSE EVENTS HAVE BEEN ASSOCIATED WITH THE USE OF THIS DEVICE. A USER MUST FULLY CONSIDER THE RISKS OF THIS DEVICE WITH THAT OF OTHER TREATMENT MODALITIES BEFORE DECIDING TO PROCEED WITH DEVICE IMPLANTATION. GI BLEEDING/AV MALFORMATIONS, PERICARDIAL EFFUSION/TAMPONADE, PLATELET DYSFUNCTION AND SENSITIVITY TO ASPIRIN ARE KNOWN POTENTIAL COMPLICATIONS ASSOCIATED WITH ALL PATIENTS IMPLANTED WITH VADS. THE INSTRUCTIONS FOR USE (IFU) ADDRESSES GUIDELINES FOR OPTIMAL PATIENT MANAGEMENT (INCLUDING THERAPEUTIC ANTICOAGULATION GUIDELINES). WITH A REVIEW OF THE AVAILABLE INFORMATION THERE IS NO INDICATION OF ANY DEVICE MALFUNCTIONS OR PERFORMANCE ISSUES THAT WOULD IMPACT THE EVENT. THERE IS ALSO NO CLINICAL EVIDENCE TO SUGGEST THAT A MALFUNCTION OF THE DEVICE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE ROOT CAUSE OF THE REPORTED EVENT CANNOT BE CONCLUSIVELY DETERMINED; THOUGH, CLINICAL FACTORS THAT MAY HAVE CONTRIBUTED INCLUDE THE PATIENT'S PREVIOUS MEDICAL HISTORY, ANTICOAGULANT THERAPY AND RELATED COMORBIDITIES. THERE ARE PATIENT, PROCEDURAL AND PHARMACOLOGICAL FACTORS THAT MAY HAVE CONTRIBUTED TO THIS EVENT. FROM ALL INDICATIONS THE DEVICE OPERATED WITHIN SPECIFICATIONS AND AS INTENDED WITH NO INDICATION OF ANY DEVICE PERFORMANCE ISSUES CONTRIBUTING TO THE EVENT. THE MANUFACTURER WILL SUBMIT A SUPPLEMENTAL REPORT WHEN NEW FACTS ARISE WHICH MATERIALLY ALTER INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT. 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 THAT THE PATIENT EXPIRED ON (B)(6) 2013 WITH A CAUSE OF DEATH BEING GI BLEED. NO OTHER DETAILS SURROUNDING THE PATIENT ADMISSION/DEATH ARE KNOWN OR WILL BE PROVIDED BY THE SITE. PUMP AND PERIPHERALS WERE NOT SENT BACK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    755100 HEARTWARE® VENTRICULAR ASSIST SYSTEM CIRCULATORY ASSIST SYSTEM, PRODUCT CODE, PRODUCT CODE DSQ HEARTWARE, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Death