BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTWARE® VENTRICULAR ASSIST SYSTEM

    MDR report key: 6511868 · Received April 21, 2017

    Report

    Report Number
    3007042319-2017-01230
    Event Type
    Death
    Date Received
    April 21, 2017
    Date of Event
    April 11, 2017
    Report Date
    April 11, 2017
    Manufacturer
    HEARTWARE, INC
    Product Code
    DSQ
    PMA / PMN Number
    P100047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED INDICATES THAT DETAILS REGARDING THE PATIENT'S SYMPTOMS AT PRESENTATION OR THE RESULTS OF ANY FURTHER DIAGNOSTIC TESTING OR MEDICAL INTERVENTIONS WERE UNKNOWN. WITH REVIEW OF THE AVAILABLE INFORMATION NO EVIDENCE TO INDICATE ANY DEVICE MALFUNCTIONS OR PERFORMANCE ISSUES OF THE DEVICE THAT WOULD IMPACT THE REPORTED EVENT. CLINICAL FACTORS THAT MAY HAVE CONTRIBUTED TO THE REPORTED EVENT INCLUDE ISSUES WITH THE MANAGEMENT OF THE PATIENT'S THERAPEUTIC ANTICOAGULANT AND ANTIPLATELET MEDICATIONS AND THE DEVELOPMENT OF A PULMONARY EMBOLUS. THOUGH THE ROOT CAUSE OF THE REPORTED EVENT CANNOT BE CONCLUSIVELY DETERMINED THERE ARE PATIENT AND POSSIBLE PHARMACOLOGICAL FACTORS THAT MAY HAVE CONTRIBUTED TO THIS EVENT. HEARTWARE WILL SUBMIT A SUPPLEMENTAL REPORT WHEN NEW FACTS ARISES WHICH MATERIALLY ALTERS INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT.

    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. THE SYSTEM IS INDICATED FOR USE UNDER THE DIRECT SUPERVISION OF A LICENSED PRACTITIONER OR BY PERSONNEL TRAINED IN ITS' PROPER USE. THESE PROFESSIONALS SHOULD BE AWARE OF THE PHYSICAL AND PSYCHOLOGICAL NEEDS OF PATIENTS UNDERGOING LVAD SUPPORT. 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. DEATH AND RIGHT HEART FAILURE ARE KNOWN POTENTIAL COMPLICATIONS THAT MAY BE ASSOCIATED WITH USE OF THIS PRODUCT AND IN ALL PATIENTS WITH HEART FAILURE. 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

    A REPORT WAS RECEIVED THAT A PATIENT UNDERWENT VAD IMPLANTATION ON (B)(6) 2017 AND WAS STILL HOSPITALIZED POST-OPERATIVELY. POST-OPERATIVELY, THE PATIENT IS REPORTED TO HAVE UNDERGONE A TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) THAT REVEALED A SADDLE EMBOLUS WITH LITTLE TO NO BLOOD FLOW THROUGH THE PULMONARY ARTERIES AND A LEFT VENTRICLE (LV) THAT WAS ESSENTIALLY COLLAPSED UNDER THE SUCTION OF THE VAD DEVICE. THE PATIENT'S PHYSICIAN NOTED THAT THE SADDLE PULMONARY ARTERY BLOCKAGE WAS MAKING VAD THERAPY INEFFECTIVE AND DETERMINED THAT THE PATIENT WOULD NO LONGER BENEFIT FROM ADVANCE HEART FAILURE SUPPORT. ATTEMPTS AT FURTHER RESUSCITATION EFFORTS WERE DISCONTINUED. THE PATIENT EXPIRED ON (B)(6) 2017 WITH A CAUSE OF DEATH LISTED AS A SADDLE PULMONARY EMBOLUS AND RIGHT VENTRICULAR FAILURE. THE PATIENT'S PHYSICIAN REPORTED THAT THE PATIENT'S DEATH WAS UNRELATED TO THE VAD DEVICE. THE PATIENT'S EQUIPMENT WILL BE DISPOSED PER THE HOSPITAL'S POLICY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    294189 HEARTWARE® VENTRICULAR ASSIST SYSTEM CIRCULATORY ASSIST SYSTEM, BATTERY DSQ HEARTWARE, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Death