BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTWARE® VENTRICULAR ASSIST SYSTEM

    MDR report key: 4211821 · Received October 29, 2014

    Report

    Report Number
    3007042319-2014-01143
    Event Type
    Injury
    Date Received
    October 29, 2014
    Date of Event
    October 13, 2014
    Report Date
    October 14, 2014
    Manufacturer
    HEARTWARE, INC
    Product Code
    DSQ
    PMA / PMN Number
    P100047
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE HVAD REMAINS IMPLANTED IN THE PATIENT, THEREFORE IT WILL NOT BE RETURNED. ADDITIONAL INFORMATION WILL BE SUBMITTED WITH-IN THIRTY (30) DAYS OF COMPLETION OF THE INVESTIGATION. DEVICE REMAINS IMPLANTED.

    Additional Manufacturer Narrative · 1

    THE HVAD IS USED FOR TREATMENT NOT DIAGNOSIS. IT WAS REPORTED THAT THIS PATIENT EXPERIENCED A "GRINDING" SOUND COMING FROM THE PUMP. THE PATIENT HAD HIGH LDH LEVELS AND SUB-THERAPEUTIC INR. THE PATIENT RECEIVED TREATMENT FOR SUSPECTED THROMBUS AND IT WAS LAST REPORTED THAT THE PATIENT RECEIVED A HEART TRANSPLANT AND WAS DOING WELL. THE DEVICE ((B)(4)) WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. REVIEW OF THE CONTROLLER LOG FILES REVEALED A DECREASING TREND IN POWER CONSUMPTION. VISUAL INSPECTION CONFIRMED MODERATE ABRASION ON THE INFERIOR SURFACE OF THE IMPELLER. THESE CONDITIONS ARE INDICATIVE THAT AN EXTERNAL FACTOR, SUCH AS A THROMBUS, MAY HAVE FORCED THE IMPELLER AGAINST THE REAR HOUSING WITH SUFFICIENT STRENGTH TO OVERCOME THE REAR PRELOAD OF THE MAGNETIC SPRING/SUSPENSION SYSTEM. NO DIMENSIONAL OR FUNCTIONAL ISSUES THAT MAY HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT WERE NOTICED DURING ANALYSIS OF THE RETURNED UNIT. PATHOLOGICAL EVALUATION REVEALED NO GROSS EVIDENCE OF DEVICE COMPLICATION OR THROMBUS FORMATION; HOWEVER, IT SHOULD BE NOTED THAT THE PUMP WAS RETURNED FOR EVALUATION ABOUT FOUR MONTHS AFTER THE REPORTED EVENT. NO DEVICE MALFUNCTION WAS CONFIRMED; THERE IS NO EVIDENCE TO SUGGEST THAT THE DEVICE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. A POSSIBLE ROOT CAUSE OF THE REPORTED EVENT MAY BE ATTRIBUTED TO THROMBUS FORMATION/INGESTION WITHIN THE DEVICE. A CLINICAL FACTOR THAT MAY HAVE CONTRIBUTED TO THE THROMBUS FORMATION WAS THE PATIENT'S SUB-THERAPEUTIC INR. 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. 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). HEARTWARE WILL SUBMIT A SUPPLEMENTAL REPORT WHEN NEW FACTS ARISES WHICH MATERIALLY ALTERS INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT. HEARTWARE IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER (B)(4), DATED JUNE 2, 2014, AND PURSUANT TO THE PROVISIONS OF 21 CFR PART 803. (B)(4).

    Description of Event or Problem · 1

    APPROXIMATELY FOUR MONTHS AFTER HVAD IMPLANTATION THIS PATIENT COMPLAINED OF A "GRINDING" SOUND FROM PUMP WHICH WAS CONFIRMED BY THE DOCTOR. THE PATIENT HAD SUBTHERAPEUTIC INR AND HIGH LACTATE DEHYDROGENASE. HE WAS ADMITTED TO THE HOSPITAL AND TREATED WITH HEPARIN GTT. AT LAST REPORT A CARDIAC COMPUTED TOMOGRAPHY SCAN HAD BEEN REQUESTED. THE DEVICE WILL NOT BE RETURNED TO HEARTWARE FOR EVALUATION AS IT REMAINS IMPLANTED. INVESTIGATION IS ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    692417 HEARTWARE® VENTRICULAR ASSIST SYSTEM CIRCULATORY ASSIST SYSTEM DSQ HEARTWARE, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Hospitalization| L| R