BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTWARE® VENTRICULAR ASSIST SYSTEM

    MDR report key: 4413989 · Received January 13, 2015

    Report

    Report Number
    3007042319-2015-00048
    Event Type
    Injury
    Date Received
    January 13, 2015
    Date of Event
    December 18, 2014
    Report Date
    December 19, 2014
    Manufacturer
    HEARTWARE, INC
    Product Code
    DSQ
    PMA / PMN Number
    P100047
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED VIA THE INTERMACS DATABASED INDICATED THE PATIENT WAS IN THE HOSPITAL AT THE TIME OF THE EVENT WITH INCREASING LDH AND DAMPENED VAD WAVEFORM. SUB-THERAPEUTIC ANTICOAGULATION WAS INDICATED AS A CAUSATIVE FACTOR. THE PUMP WAS EXPLANTED ON (B)(6) 2014. RELEVANT TESTS/LABORATORY DATA, INCLUDING DATES: LABS: LDH - (B)(6) 2014 =207, (B)(6) 2014=223, (B)(6) 2014=378, (B)(6) 2014=333. RELEVANT HISTORY: "PRE-IMPLANT CHRONIC INFECTIOUS CONCERNS". THE PUMP WAS NOT RETURNED TO THE MANUFACTURER FOR ANALYSIS. WITH REVIEW OF THE AVAILABLE INFORMATION AND AS REPORTED, THIS PATIENT'S SUB-THERAPEUTIC ANTICOAGULATION ALONG WITH CHRONIC INFECTION CONCERNS PUT HIM AT GREATER RISK FOR THROMBUS. REVIEW OF THE MANUFACTURING DOCUMENTATION CONFIRMED THAT THE ASSOCIATED DEVICE MET ALL REQUIREMENTS FOR RELEASE. THERE IS NO EVIDENCE TO SUGGEST THAT A DEVICE MALFUNCTION CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. WITH REVIEW OF THE AVAILABLE INFORMATION THERE IS NO INDICATION OF ANY DEVICE PERFORMANCE ISSUES RELATED TO THE EVENT WITH PATIENT, CLINICAL, AND PHARMACOLOGICAL FACTORS APPEARING TO HAVE CONTRIBUTED. HEARTWARE WILL SUBMIT A SUPPLEMENTAL REPORT WHEN NEW FACTS ARISES WHICH MATERIALLY ALTERS INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFO RECEIVED REVEALS THE PATIENT'S PUMP WAS EXCHANGED DURING THIS HOSPITALIZATION DUE TO THROMBUS, DATE UNKNOWN. PUMP NOT RETURNED. HEARTWARE WILL SUBMIT A SUPPLEMENTAL REPORT WHEN NEW FACTS ARISES WHICH MATERIALLY ALTERS INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT.

    Additional Manufacturer Narrative · 1

    THE SITE HAS INDICATED THAT THE PUMP IS GOING TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION. THIS DEVICE IS USED FOR TREATMENT AND 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, INCLUDING TRANSPORTATION. SERIOUS AND LIFE THREATENING ADVERSE EVENTS, INCLUDING DEVICE THROMBOSIS, HAVE BEEN ASSOCIATED WITH USE OF THIS DEVICE AS OUTLINED IN THE INSTRUCTIONS FOR USE (IFU). THE IFU ADDRESSES GUIDELINES FOR OPTIMAL PATIENT MANAGEMENT (INCLUDING THERAPEUTIC ANTICOAGULATION GUIDELINES OF INR BETWEEN 2.0 AND 3.0). DEVICE REMAINS IMPLANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A SUSPECTED PUMP THROMBOSIS. THE TREATING FACILITY EXCHANGED THE PATIENT'S PUMP. THE DEVICE WILL BE SENT BACK TO THE MANUFACTURER FOR EVALUATION. THERE IS NO FURTHER INFORMATION AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    30791 HEARTWARE® VENTRICULAR ASSIST SYSTEM CIRCULATORY ASSIST SYSTEM DSQ HEARTWARE, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization| L| R