BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTWARE® VENTRICULAR ASSIST SYSTEM

    MDR report key: 4760305 · Received May 8, 2015

    Report

    Report Number
    3007042319-2015-00778
    Event Type
    Injury
    Date Received
    May 8, 2015
    Date of Event
    April 3, 2015
    Report Date
    December 18, 2024
    Manufacturer
    HEARTWARE, INC
    Product Code
    DSQ
    PMA / PMN Number
    P100047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LU
    Reporter Occupation
    OTHER
    Health Professional
    N

    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. THE IFU STATES: 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 ARE ASSOCIATED WITH NUMEROUS RISKS. ADVERSE EVENTS THAT MAY BE ASSOCIATED WITH THE USE OF THIS SYSTEM INCLUDE BUT ARE NOT LIMITED TO THE RISK OF STROKE. THE MANUFACTURER WILL SUBMIT A SUPPLEMENTAL REPORT WHEN NEW FACTS ARISE WHICH MATERIALLY ALTERS INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT. DEVICE REMAINS IMPLANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED FROM LUXEMBOURG BY THE PERFUSIONIST THAT A PATIENT WAS TRANSPORT FROM HOME TO THE HOSPITAL BECAUSE OF DIZZINESS AND HEADACHE. THE PATIENT WAS INTUBATED AND A COMPUTED TOMOGRAPHY-SCAN WAS DONE WHICH SHOWED SPONTANEOUS HEMORRHAGIC CEREBROVASCULAR ACCIDENT (HCVA). ANTICOAGULATION MEDICATION WAS STOPPED. IT WAS REPORTED THAT THE PHYSICIANS WOULD TRY TO AWAKEN THE PATIENT FOR FURTHER EVALUATION. IT WAS LAST REPORTED THE PATIENT REMAINS IN THE HOSPITAL AS OF (B)(6) 2015. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    302640 HEARTWARE® VENTRICULAR ASSIST SYSTEM CIRCULATORY ASSIST SYSTEM DSQ HEARTWARE, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Male Hospitalization| R