BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTWARE® VENTRICULAR ASSIST SYSTEM-PUMP

    MDR report key: 6893190 · Received September 26, 2017

    Report

    Report Number
    3007042319-2017-03276
    Event Type
    Injury
    Date Received
    September 26, 2017
    Date of Event
    February 1, 2017
    Report Date
    August 28, 2017
    Manufacturer
    HEARTWARE, INC
    Product Code
    DSQ
    PMA / PMN Number
    P100047
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DOI.ORG/10.14503/THIJ-15-5628. DIEGO A. LARA, MD, MPH. AAMIR JEEWA, MD. BARBARA A. ELIAS, RN, CCRN. ELIZABETH O. MCCULLUM, PHD. SUSAN W. DENFIELD, MD. WILLIAM J. DREYER, MD. IKI ADACHI, MD. TITANIUM PLUG CLOSURE AFTER HEARTWARE VENTRICULAR ASSIST DEVICE EXPLANTATION IN A (B)(6) GIRL: FIRST U.S. EXPERIENCE 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. WITH A REVIEW OF THE AVAILABLE INFORMATION THERE IS NO EVIDENCE TO INDICATE ANY DEVICE MALFUNCTIONS OR PERFORMANCE ISSUES THAT WOULD IMPACT THE REPORTED EVENTS. POSSIBLE CLINICAL FACTORS THAT MAY HAVE CONTRIBUTED TO THIS EVENT INCLUDE THE PATIENT'S PRE-EXISTING HISTORY AND RELATED COMORBIDITIES, THE PROGRESSION OF THEIR UNDERLYING DISEASE, ISSUES RELATED TO THE THERAPEUTIC USE OF ANTICOAGULANT AND ANTIPLATELET MEDICATIONS AND THE PATIENT'S COMPLEX POST-OPERATIVE COURSE. WITH A REVIEW OF THE AVAILABLE INFORMATION THERE IS NO EVIDENCE TO INDICATE ANY DEVICE MALFUNCTIONS OR PERFORMANCE ISSUES THAT WOULD IMPACT THE REPORTED EVENTS. POSSIBLE CLINICAL FACTORS THAT MAY HAVE CONTRIBUTED TO THIS EVENT INCLUDE THE PATIENT'S PRE-EXISTING HISTORY AND RELATED COMORBIDITIES, THE PROGRESSION OF THEIR UNDERLYING DISEASE, ISSUES RELATED TO THE THERAPEUTIC USE OF ANTICOAGULANT AND ANTIPLATELET MEDICATIONS AND THE PATIENT'S COMPLEX POST-OPERATIVE COURSE. 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 JOURNAL ARTICLE WAS REVIEWED WHICH DESCRIBED A (B)(6) GIRL WITH ANTHRACYCLINE-INDUCED CARDIOMYOPATHY WHO WAS SUCCESSFULLY BRIDGED TO RECOVERY AFTER 12 MONTHS OF SUPPORT FROM A LEFT VENTRICULAR ASSIST DEVICES (LVAD). THE LVAD WAS REMOVED VIA REPEAT STERNOTOMY. A SMALL MURAL THROMBUS WAS REMOVED FROM THE LEFT VENTRICLE CAVITY NEAR THE CANNULATION SITE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    674902 HEARTWARE® VENTRICULAR ASSIST SYSTEM-PUMP CIRCULATORY ASSIST SYSTEM DSQ HEARTWARE, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Hospitalization| L| R