BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTWARE® VENTRICULAR ASSIST SYSTEM

    MDR report key: 4102674 · Received September 19, 2014

    Report

    Report Number
    3007042319-2014-00975
    Event Type
    Malfunction
    Date Received
    September 19, 2014
    Date of Event
    September 4, 2014
    Report Date
    September 4, 2014
    Manufacturer
    HEARTWARE, INC
    Product Code
    DSQ
    PMA / PMN Number
    P100047
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE HEARTWARE VAD IS USED FOR TREATMENT NOT DIAGNOSIS. THE CONTROLLER WAS RETURNED TO THE MANUFACTURER FOR EVALUATION FOR EVALUATION. VARIOUS ANALYSES WERE CONDUCTED AND REVIEWED IN ORDER TO EVALUATE THE PERFORMANCE OF THE DEVICE IN RELATION TO THE REPORTED EVENT. REVIEW OF THE MANUFACTURING DOCUMENTATION CONFIRMED THAT THE ASSOCIATED DEVICE MET ALL REQUIREMENTS FOR RELEASE. THE REPORTED ALARMS OR FAULTS OR COULD NOT BE CONFIRMED VIA LOG FILE ANALYSIS AS CONTROLLER ALARM FILES DO NOT COVER THE REPORTED EVENT DATE. ADDITIONALLY, THE REPORTED 'INADEQUATE FLOW' EVENT COULD NOT BE CONFIRMED VIA LOG FILE ANALYSIS AS THE DATA FILES DO NOT COVER THE REPORTED EVENT DATE. HOWEVER, LOG FILE ANALYSIS DID REVEAL A SIGNIFICANT DROP IN FLOW AND POWER READING TWO WEEKS BEFORE THE REPORTED EVENT DATE WHICH COULD BE INDICATIVE OF AN OCCLUSION WITHIN THE DEVICE. THE DEVICE IS RELATED TO THE REPORTED EVENT; HOWEVER, THERE ISN'T ENOUGH EVIDENCE TO SUGGEST THAT A DEVICE MALFUNCTION CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. APPLICABLE RISK DOCUMENTATION AND EXPERIENCE WITH SIMILAR CIRCUMSTANCES WERE CONSIDERED; EVENTS WITH INADEQUATE FLOW MAY BE ATTRIBUTED TO AN OCCLUSION. 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): ADVERSE EVENTS THAT MAY BE ASSOCIATED WITH THE USE OF VENTRICULAR ASSIST DEVICES, OTHER THAN DEATH, INCLUDE DEVICE THROMBOSIS. 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.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN THIRTY (30) DAYS OF RECEIPT. DEVICE REMAINS IMPLANTED.

    Description of Event or Problem · 1

    APPROXIMATELY ONE AND A HALF MONTHS AFTER IMPLANT, THIS PATIENT EXPERIENCED A SUDDEN DECREASE IN PUMP FLOW AND A CONTROLLER EXCHANGE WAS PERFORMED. THERE WERE NO ASSOCIATED SYMPTOMS OR INJURIES. INVESTIGATION IS ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    581703 HEARTWARE® VENTRICULAR ASSIST SYSTEM CIRCULATORY ASSIST SYSTEM DSQ HEARTWARE, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 CONTROLLER - (B)(4)