BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTWARE® VENTRICULAR ASSIST SYSTEM

    MDR report key: 4913420 · Received July 14, 2015

    Report

    Report Number
    3007042319-2015-01462
    Event Type
    Injury
    Date Received
    July 14, 2015
    Date of Event
    June 27, 2015
    Report Date
    June 30, 2015
    Manufacturer
    HEARTWARE, INC
    Product Code
    DSQ
    PMA / PMN Number
    P100047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BIRTH YEAR: 1967. IT WAS ADDITIONALLY REPORTED THAT THERE WERE HEART FAILURE SYMPTOMS. ANTICOAGULATION WAS DESCRIBED AS CONTROLLED. THE PUMP WAS EXAMINED AT THE IMPLANTING FACILITY AND THE RESULTS ARE FROM THAT FACILITY. THE PUMP WAS NOT RETURNED TO THE MANUFACTURER FOR ANALYSIS. THE PUMP WAS NOT RETURNED FOR EVALUATION. 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 WATT" ALARMS. EXAMINATION OF THE EXPLANTED PUMP BY THE SITE SHOWED THE PRESENCE OF SMALL THROMBUS MATERIAL. 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 MOST LIKELY ROOT CAUSE OF THE HIGH POWER EVENT IS THROMBUS FORMATION OR INGESTION WITHIN THE DEVICE. HEARTWARE WILL SUBMIT A SUPPLEMENTAL REPORT IF NEW FACTS ARISE WHICH MATERIALLY ALTER INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT.

    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 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. 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 INSTRUCTIONS FOR USE ALSO ADDRESS SETTING PARAMETERS FOR THE HIGH POWER ALARM THRESHOLD, HOW TO RECOGNIZE HIGH WATT ALARMS AND GUIDELINES FOR OPTIMAL PATIENT MANAGEMENT (INCLUDING THERAPEUTIC ANTICOAGULATION GUIDELINES) PER THE INSTRUCTIONS FOR USE (IFU): SERIOUS AND LIFE THREATENING ADVERSE EVENTS, INCLUDING DEATH AND BLEEDING HAVE BEEN ASSOCIATED WITH USE OF THIS DEVICE AS OUTLINED IN THE INSTRUCTIONS FOR USE (IFU). THE IFU INDICATES THAT ANTICOAGULATION SHOULD BE INDIVIDUALIZED FOR EACH PATIENT. MISSING INFORMATION FROM THIS REPORT IS IDENTIFIED AS A BLANK, UNKNOWN AND AS NO INFORMATION (NI); THIS INFORMATION WAS NOT PROVIDED IN THE REPORTED EVENT OR AVAILABLE AT THE TIME OF REPORT SUBMISSION. THE COMPANY IS SEEKING THIS INFORMATION THROUGH THE EVENT INVESTIGATION. DEVICE NOT AVAILABLE FOR RETURN.

    Description of Event or Problem · 1

    IT WAS REPORTED FROM (B)(6) BY THE VAD COORDINATOR THAT THE PATIENT CAME INTO THE CLINIC DUE TO A SUSPECTED PUMP THROMBOSIS (HIGH POWER ALARM) BUT IT WAS IMPOSSIBLE TO CONNECT TO THE CONTROLLER TO DOWNLOAD THE LOG FILES. LDH > 2700, FHB APPROXIMATELY 500. IT WAS DECIDED TO REPLACE THE PUMP. A PUMP EXCHANGE WAS COMPLETED. LAB VALUES DECREASED AFTER PUMP EXCHANGE. NO OTHER INFORMATION REGARDING THE PATIENT'S CONDITION WAS REPORTED. THE PUMP ANALYSIS RESULTS WERE: COMPARED TO OTHER THROMBUS FORMATIONS THIS ONE IS QUITE SMALL AND CAUSES HEMOLYSIS AND A SIGNIFICANT 3RD HARMONY (IMBALANCE OF THE ROTOR). IT MIGHT BE THAT THE HIGHER BLOOD FLOW THROUGH THE BIGGER GAP OF THE BEARING, AN AREA WITH HIGH SHEAR STRESS, CAUSES HIGHER BLOOD DAMAGE. THE CONTACT OF THE ROTOR AND THE PUMP HOUSING ALSO MIGHT CAUSE HIGHER BLOOD DAMAGE. NO FURTHER INFORMATION IS AVAILABLE AND INVESTIGATION IS IN PROGRESS. THIS COMPLAINT IS ONLY FOR THE PUMP EXCHANGE ONLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    456027 HEARTWARE® VENTRICULAR ASSIST SYSTEM CIRCULATORY ASSIST SYSTEM DSQ HEARTWARE, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Hospitalization| R| S