BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTWARE® VENTRICULAR ASSIST SYSTEM

    MDR report key: 4211792 · Received October 29, 2014

    Report

    Report Number
    3007042319-2014-01170
    Event Type
    Injury
    Date Received
    October 29, 2014
    Date of Event
    October 10, 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
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE HEARTWARE VENTRICULAR ASSIST DEVICE (VAD) IS USED FOR TREATMENT NOT DIAGNOSIS. THE PATIENT RECEIVED A PUMP EXCHANGE AS A RESULT OF THE 'HIGH POWER' EVENT WHICH RESOLVED THE PATIENT SYMPTOMS; HOWEVER, THE SITE INDICATED THAT THE DEVICE WILL NOT BE RETURNED TO THE MANUFACTURER FOR EVALUATION. MOREOVER, LOG FILES COVERING THE EVENT DATE WERE NOT AVAILABLE. REVIEW OF THE MANUFACTURING DOCUMENTATION CONFIRMED THAT THE ASSOCIATED DEVICES MET ALL REQUIREMENTS FOR RELEASE. THE DEVICE IS RELATED TO THE REPORTED EVENT; HOWEVER, THERE IS NO EVIDENCE TO SUGGEST THAT A DEVICE MALFUNCTION CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE SITE REPORTED THAT THE PATIENT'S INR WAS UNCONTROLLED WHICH MAY HAVE BEEN A CONTRIBUTING FACTOR TO THE POSSIBLE THROMBUS FORMATION. APPLICABLE RISK DOCUMENTATION AND EXPERIENCE WITH SIMILAR CIRCUMSTANCES WERE CONSIDERED; EVENTS WITH HIGH POWER CONSUMPTION ARE MOST OFTEN ATTRIBUTED TO THROMBUS FORMATION. THE MOST LIKELY ROOT CAUSE OF THE HIGH POWER CONSUMPTION AND SUSPECTED THROMBUS CANNOT BE CONCLUSIVELY DETERMINED; HOWEVER THERE ARE PATIENT, PROCEDURAL, AND PHARMACOLOGICAL FACTORS THAT MAY HAVE CONTRIBUTED TO THIS EVENT. HEARTWARE WILL SUBMIT A SUPPLEMENTAL REPORT WHEN NEW FACTS ARISES WHICH MATERIALLY ALTERS INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT. 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). WHILE THERE IS NO EVIDENCE BASED ON THE AVAILABLE INFORMATION, IT MAY BE POSSIBLE THAT THERE WERE SOME UNDERLYING HEALTH CONDITIONS THAT COULD HAVE PREDISPOSED THE PATIENT TO THIS EVENT. FROM ALL INDICATIONS THE DEVICE OPERATED WITHIN SPECIFICATIONS AND AS INTENDED WITH NO INDICATION OF ANY DEVICE PERFORMANCE ISSUES CONTRIBUTING TO THE EVENT. HEARTWARE IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER FLA-14-14, DATED JUNE 2, 2014, AND PURSUANT TO THE PROVISIONS OF 21 CFR PART 803. DEVICE NOT RETURNED.

    Additional Manufacturer Narrative · 1

    THE DEVICE IS AVAILABLE FOR EVALUATION, BUT HAS NOT BEEN RECEIVED BY THE MANUFACTURER. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN THIRTY (30) DAYS OF RECEIPT.

    Description of Event or Problem · 1

    APPROXIMATELY THREE MONTHS AFTER HVAD IMPLANTATION THIS PATIENT HAS HOSPITALIZED FOR HIGH FLOWS AND POWERS WITH SIGNS OF HEMOLYSIS AND UNDERWENT AN EMERGENT PUMP EXCHANGE. PATIENT PRESENTED WITH HEMATURIA, ELEVATED PLASMA-FREE HEMOGLOBIN AND/OR LACTATE DEHYDROGENASE AND ABNORMAL PUMP PARAMETERS. THE PATIENT'S ANTICOAGULATION WAS UNCONTROLLED AND HE REPORTED "INR HAD A LOT OF CHANGES IN THE PAST." DURING ADMISSION HE FURTHER REQUIRED INOTROPE SUPPORT AND THE DECISION WAS MADE TO EXCHANGE THE PUMP. THE PATIENT IS STABLE ON CARDIAC INTENSIVE CARE UNIT BUT REMAINS VENTILATED. THE EXCHANGED DEVICE WILL BE RETURNED TO HEARTWARE FOR EVALUATION AS IT REMAINS IMPLANTED. INVESTIGATION IS ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    691985 HEARTWARE® VENTRICULAR ASSIST SYSTEM CIRCULATORY ASSIST SYSTEM DSQ HEARTWARE, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R