BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTWARE® VENTRICULAR ASSIST SYSTEM

    MDR report key: 3841365 · Received May 30, 2014

    Report

    Report Number
    3007042319-2014-00530
    Event Type
    Injury
    Date Received
    May 30, 2014
    Date of Event
    May 5, 2014
    Report Date
    May 5, 2014
    Manufacturer
    HEARTWARE, INC
    Product Code
    DSQ
    PMA / PMN Number
    P100047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE HVAD IS USED FOR TREATMENT NOT DIAGNOSIS. IT WAS REPORTED THAT THE PATIENT WAS ADMITTED TO THE HOSPITAL WITH ELEVATED LACTATE DEHYDROGENASE (LDH) AND 'HIGH WATTS' ALARMS. THE PATIENT RECEIVED TREATMENT FOR SUSPECTED THROMBUS AND ADVISED TO CONTINUE WITH THEIR CURRENT DOSE OF COUMADIN FOR THAT DAY BUT FUTURE DOSES WERE ADJUSTED. IT WAS LAST REPORTED THAT THE PATIENT REMAINED HOSPITALIZED. THE DEVICE ((B)(4)) WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION AS IT REMAINED IMPLANTED; HOWEVER, REVIEW OF THE MANUFACTURING DOCUMENTATION CONFIRMED THAT THE ASSOCIATED DEVICE MET ALL REQUIREMENTS FOR RELEASE. THE REPORTED EVENT WAS CONFIRMED VIA REVIEW OF THE CONTROLLER LOG FILES, WHICH REVEALED MULTIPLE 'HIGH WATTS' ALARMS LOGGED FROM (B)(4) 2014 AND AN INCREASE IN POWER CONSUMPTION AND ESTIMATED FLOW. A POSSIBLE ROOT CAUSE FOR THE REPORTED EVENT MAY BE ATTRIBUTED TO THROMBUS FORMATION/INGESTION WITHIN THE DEVICE; HOWEVER, THERE ARE PATIENT, PROCEDURAL AND PHARMACOLOGICAL FACTORS THAT MAY HAVE CONTRIBUTED TO THIS EVENT. A POSSIBLE CLINICAL FACTOR THAT MAY HAVE CONTRIBUTED TO THE THROMBUS FORMATION IS THE PATIENT MISSING A DOSE OF COUMADIN AND CONSUMING MORE FOODS CONTAINING VITAMIN K. THROMBUS IS A KNOWN RISK ASSOCIATED WITH USE OF VENTRICULAR ASSIST DEVICES NOTED WITHIN THE LABELING. 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). PER THE INSTRUCTIONS FOR USE (IFU): HIGH WATTS ALARMS, ARE AN INDICATION THAT THE PUMP WATTS HAS EXCEEDED THE HIGH POWER ALARM THRESHOLD, MAY BE INDICATIVE OF THROMBUS OR OTHER TISSUE FRAGMENTS IN THE PUMP, WHICH ARE KNOWN POTENTIAL COMPLICATIONS ASSOCIATED WITH ALL PATIENTS IMPLANTED WITH VADS AS OUTLINED IN THE LABELING. THE IFU ADDRESSES SETTING PARAMETERS FOR THE HIGH POWER ALARM THRESHOLD, HOW TO RECOGNIZE HIGH WATT ALARMS AND GUIDELINES FOR OPTIMAL PATIENT MANAGEMENT (INCLUDING THERAPEUTIC ANTICOAGULATION GUIDELINES). 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 FLA-14-14, DATED JUNE 2, 2014, AND PURSUANT TO THE PROVISIONS OF 21 CFR PART 803.

    Additional Manufacturer Narrative · 1

    THE PRODUCT REMAINS IMPLANTED IN THE PATIENT, THEREFORE, IT WILL NOT BE RETURNED. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN THIRTY (30) DAYS OF RECEIPT. DEVICE REMAINS IMPLANTED.

    Description of Event or Problem · 1

    APPROXIMATELY FIFTEEN MONTHS POST HVAD IMPLANTATION THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR HIGH POWER. PRELIMINARY LOG FILE ANALYSIS INDICATES A RISE IN POWER BEGINNING FOUR DAYS PRIOR TO THE DAY OF THE REPORTED EVENT. INR WAS DRAWN BUT RESULTS RETURNED HEMOLYZED. REPEAT INR WAS REDRAWN LATER THAT DAY BUT RESULTS WERE NOT PROVIDED. LDH ON ADMISSION WAS ELEVATED AND THE PATIENT WAS SUBSEQUENTLY STARTED ON AN INTRAVENOUS HEPARIN INFUSION. THE PATIENT REPORTED TO HOSPITAL STAFF THAT THE WEEK PRIOR HE/SHE HAD MISSED A DOSE OF COUMADIN AND HAD CONSUMED MORE FOODS CONTAINING VITAMIN K. THE PATIENT WAS ADVISED TO CONTINUE WITH THEIR CURRENT DOSE OF COUMADIN FOR THAT DAY BUT FUTURE DOSES WERE ADJUSTED. ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE PATIENT REMAINED IN THE INTENSIVE CARE UNIT ON A HEPARIN INFUSION. INVESTIGATION IS ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319481 HEARTWARE® VENTRICULAR ASSIST SYSTEM CIRCULATORY ASSIST SYSTEM DSQ HEARTWARE, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R COUMADIN