BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTWARE® VENTRICULAR ASSIST SYSTEM

    MDR report key: 3953862 · Received July 23, 2014

    Report

    Report Number
    3007042319-2014-00763
    Event Type
    Injury
    Date Received
    July 23, 2014
    Date of Event
    June 25, 2014
    Report Date
    June 25, 2014
    Manufacturer
    HEARTWARE, INC
    Product Code
    DSQ
    PMA / PMN Number
    P100047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE HVAD IS USED FOR TREATMENT NOT DIAGNOSIS. IT WAS REPORTED THAT THE PATIENT HAD INADEQUATE FLOW RATES FROM THE TIME OF IMPLANT. THE PATIENT WAS TAKEN TO THE OPERATING ROOM TO REPOSITION THE LVAD UNSUCCESSFULLY AND WAS TRANSPLANTED ON (B)(6) 2014. THE PATIENT WAS DISCHARGED AND WAS STATED TO BE DOING WELL. THE DEVICE WAS RETURNED FOR EVALUATION. REVIEW OF THE MANUFACTURING DOCUMENTATION CONFIRMED THAT THE ASSOCIATED DEVICE MET ALL REQUIREMENTS FOR RELEASE. IT IS NOT BELIEVED THAT THE DEVICE HAS CAUSE OR CONTRIBUTE TO THE REPORTED EVENT. THE EVENT WAS CONFIRMED VIA LOG FILES WHICH REVEALED 'INADEQUATE FLOW RATE'. THE MOST PROBABLE ROOT CAUSE OF THE REPORTED INADEQUATE FLOW RATE EVENT IS ATTRIBUTED INFLOW CANNULA BLOCKED DUE TO INCORRECT PLACEMENT. 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. THE INSTRUCTIONS FOR USE (IFU) PROVIDE CLEAR INSTRUCTIONS TO MEDICAL PERSONNEL ON PROPER USAGE AND PLACEMENT OF THE HVAD SYSTEM IN ADDITION TO APPROPRIATE HVAD PUMP PARAMETERS. MOREOVER, THE IFU PROVIDES INSTRUCTION TO FURTHER EDUCATE THE PATIENT ABOUT PRODUCT SAFETY, ALARM MANAGEMENT, AND ANTICOAGULATION RECOMMENDATIONS; ADDITIONAL GUIDELINES INSTRUCT BOTH THE USER AND MEDICAL PERSONNEL ON HOW TO RECOGNIZE VENTRICULAR SUCTION ALARMS, THE POTENTIAL CAUSES OF THESE ALARMS, AND THE POTENTIAL COURSES OF ACTION. 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

    THE DEVICE HAS BEEN RECEIVED AND IS AWAITING FURTHER ANALYSIS. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN THIRTY (30) DAYS OF COMPLETION OF THE INVESTIGATION. EVALUATION IN PROGRESS.

    Description of Event or Problem · 1

    THIS PATIENT EXPERIENCED PERSISTENT INADEQUATE FLOW RATES POST HVAD IMPLANTATION REQUIRING A RETURN TO THE OPERATING ROOM TO REPOSITION THE VAD. THE PATIENT MAINTAINED RELATIVELY WELL DESPITE CONTINUED LOW FLOWS AFTER THE RE-OPERATION. HE WAS TRANSPLANTED APPROXIMATELY FOUR MONTHS LATER. THE EXPLANTED PUMP WAS RETURNED TO THE MANUFACTURER FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    431277 HEARTWARE® VENTRICULAR ASSIST SYSTEM CIRCULATORY ASSIST SYSTEM DSQ HEARTWARE, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization| L| R