BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTWARE VENTRICULAR ASSIST SYSTEM- PUMP

    MDR report key: 7790049 · Received August 16, 2018

    Report

    Report Number
    3007042319-2018-03842
    Event Type
    Injury
    Date Received
    August 16, 2018
    Date of Event
    August 1, 2008
    Report Date
    October 29, 2018
    Manufacturer
    HEARTWARE, INC.
    Product Code
    DSQ
    PMA / PMN Number
    P100047
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    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 AND DESTINATION THERAPY 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. THIS INFORMATION IS BASED ENTIRELY ON JOURNAL LITERATURE. THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS LIMITED DUE TO CONFIDENTIALITY CONCERNS. WITHOUT A LOT NUMBER OR DEVICE SERIAL NUMBER, THE MANUFACTURING DATE CANNOT BE DETERMINED. SINCE NO DEVICE ID WAS PROVIDED, IT IS UNKNOWN IF THIS EVENT HAS BEEN PREVIOUSLY REPORTED. REQUEST FOR ADDITIONAL INFORMATION WILL BE MADE AND UPON RECEIPT A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY. REFERENCED ARTICLE: SUCCESSFUL TREATMENT OF ROTARY PUMP THROMBUS WITH THE GLYCOPROTEIN IIB/IIIA INHIBITOR TIROFIBAN. THE JOURNAL OF HEART AND LUNG TRANSPLANTATION, AUGUST 2008; 27(8): 925¿927. DOI: 10.1016/J.HEALUN.2008.05.015. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: A PUMP WITH UNKNOWN SERIAL NUMBER WAS NOT RETURNED FOR EVALUATION. REVIEW OF STERILITY CERTIFICATES COULD NOT BE PERFORMED SINCE THE SERIAL NUMBER OF THE DEVICE IS UNKNOWN. THE REPORTED EVENT CANNOT BE CONFIRMED DUE TO INSUFFICIENT INFORMATION. THERE IS NO EVIDENCE TO SUGGEST THAT A DEVICE MALFUNCTION CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. BASED ON RISK DOCUMENTATION, MULTIPLE FACTORS MAY HAVE CONTRIBUTED TO THE REPORTED HIGH POWER/EXCESSIVE VIBRATION EVENT INCLUDING BUT NOT LIMITED TO THROMBUS FORMATION/INGESTION, HIGH FLOWS, OR INCORRECT SETTING OF ALARM THRESHOLD. MULTIPLE FACTORS MAY HAVE CONTRIBUTED TO THE REPORTED LOW FLOW EVENT INCLUDING BUT NOT LIMITED TO THROMBUS AT THE INFLOW CANNULA/OUTFLOW GRAFT, CONSTRICTION AT THE OUTFLOW GRAFT, POOR VAD FILLING, INAPPROPRIATE PUMP ROTATIONAL SPEED. 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. THERE ARE POSSIBLE PATIENT, PHARMACOLOGICAL AND PROCEDURAL FACTORS THAT MAY HAVE CONTRIBUTED TO THIS EVENT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    A JOURNAL ARTICLE WAS REVIEWED WHICH CONTAINED INFORMATION REGARDING VENTRICULAR ASSIST DEVICES (VADS). THE ARTICLE WAS A CASE REPORT ON TREATMENT OF A PUMP THROMBUS USING TIROFIBAN. ONE PATIENT WAS HOSPITALIZED FOR TREATMENT OF A PERCUTANEOUS DRIVELINE INFECTION. THE PUMP THEN DEVELOPED HIGH POWER SPIKES, LOW AND VARYING FLOWS AND WAS REPORTED TO BE NOISY, WITH THE PATIENT EXHIBITING AN INCREASE IN PLASMA FREE HEMOGLOBIN. A PUMP THROMBUS WAS SUSPECTED AND INTRAVENOUS HEPARIN AND TIROFIBAN WERE ADMINISTERED AND A TRANSTHORACIC ECHOCARDIOGRAM (TTE) WAS PERFORMED. THE PATIENT ALSO RECEIVED BLOOD PRODUCT TRANSFUSION FOR HEAVY MENSTRUAL BLEEDING IN THE SETTING OF INCREASED ANTICOAGULATION. THE VAD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    629555 HEARTWARE VENTRICULAR ASSIST SYSTEM- PUMP VENTRICULAR (ASSISST) BYPASS DSQ HEARTWARE, INC. UNK-PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Hospitalization| L| R