BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTWARE® VENTRICULAR ASSIST SYSTEM

    MDR report key: 5362816 · Received January 13, 2016

    Report

    Report Number
    3007042319-2016-00203
    Event Type
    Injury
    Date Received
    January 13, 2016
    Date of Event
    December 10, 2015
    Report Date
    December 18, 2015
    Manufacturer
    HEARTWARE, INC.
    Product Code
    DSQ
    PMA / PMN Number
    P100047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED ON APRIL 04, 2016. PATIENT WAS TRANSPLANTED ON (B)(6) 2016 DUE TO STATUS OF 1A DUE TO RV FAILURE. RIGHT HEART FAILURE IS A POTENTIAL EVENT THAT MAY BE ASSOCIATED WITH USE OF THE PRODUCT. RIGHT HEART FAILURE USUALLY DEVELOPS WITHIN THE FIRST 24 HOURS AFTER LVAD IMPLANT. THE IFU PROVIDES GUIDELINES ON MANAGEMENT OF RIGHT HEART FAILURE. PATIENTS IMPLANTED WITH VAD'S OFTEN HAVE PREEXISTING CONDITIONS THAT MAY EXACERBATE RIGHT HEART FAILURE. HEARTWARE WILL SUBMIT A SUPPLEMENTAL REPORT WHEN NEW FACTS ARISES WHICH MATERIALLY ALTERS 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. RIGHT HEART FAILURE IS A POTENTIAL EVENT THAT MAY BE ASSOCIATED WITH USE OF THE PRODUCT. RIGHT HEART FAILURE USUALLY DEVELOPS WITHIN THE FIRST 24 HOURS AFTER LVAD IMPLANT. THE IFU PROVIDES GUIDELINES ON MANAGEMENT OF RIGHT HEART FAILURE. PATIENTS IMPLANTED WITH VAD'S OFTEN HAVE PREEXISTING CONDITIONS THAT MAY EXACERBATE RIGHT HEART FAILURE. A REVIEW OF THE AVAILABLE INFORMATION DOES NOT INDICATE ANY DEVICE MALFUNCTIONS OR PERFORMANCE ISSUES THAT WOULD IMPACT THE REPORTED EVENT. THE ROOT CAUSE OF THE REPORTED EVENT CANNOT BE CONCLUSIVELY DETERMINED; HOWEVER, CLINICAL FACTORS THAT MAY HAVE CONTRIBUTED INCLUDE THE PATIENT'S UNIQUE ANATOMY, AND RELATED COMORBITIES. THERE ARE PATIENT AND PROCEDURAL FACTORS THAT MAY HAVE CONTRIBUTED TO THIS EVENT.

    Additional Manufacturer Narrative · 1

    A PUMP, TWO CONTROLLERS, AND FOUR BATTERIES WERE RETURNED FOR EVALUATION. THIS COMPLAINT IS ASSOCIATED WITH A CLINICAL ADVERSE EVENT, NO DEVICE MALFUNCTION WAS REPORTED AGAINST THE RETURNED DEVICES; THEREFORE, THE PURPOSE OF THIS INVESTIGATION IS SOLELY TO EVALUATE THE DEVICES' CONFORMANCE TO INTERNAL RELEASE REQUIREMENTS AND/OR TO IDENTIFY ANOMALIES POTENTIALLY INTRODUCED DURING USE THAT MAY HAVE PREVENTED THE DEVICES FROM PERFORMING AS INTENDED. ANALYSIS OF (B)(4) REVEALED THAT THE CONTROLLER MET SPECIFICATIONS; THE CONTROLLER PASSED VISUAL INSPECTION AND FUNCTIONAL TESTING. ANALYSIS OF (B)(4) REVEALED THAT THE DEVICES MET SPECIFICATIONS; THE DEVICES PASSED VISUAL INSPECTION AND FUNCTIONAL TESTING BUT ANALYSIS OF LOG FILES DEMONSTRATED EVIDENCE OF COMMUNICATION ERRORS BETWEEN THE CONTROLLER AND BATTERIES. HEARTWARE OPENED AN INVESTIGATION TO FURTHER EVALUATE COMMUNICATION ERRORS BETWEEN THE CONTROLLER AND BATTERIES. THESE OBSERVATIONS ARE NOT RELATED TO THE REPORTED EVENT. ANALYSIS OF (B)(4) REVEALED THAT THE PUMP FAILED TO MEET SPECIFICATIONS; THE PUMP PASSED VISUAL INSPECTION AND DIMENSIONAL VERIFICATION BUT FAILED FUNCTIONAL TESTING DUE TO A POWER SHIFT EXPERIENCED DURING POST EXPLANT WET TEST. HOWEVER, AN INTERNAL INVESTIGATION CONDUCTED VIA (B)(4) DEMONSTRATED THAT THERE IS NO CORRELATION BETWEEN POWER SHIFTS AND COMPLAINTS. FURTHER REVIEW OF THE POWER SHIFT CONDITION REVEALED THAT THE MAXIMUM POWER ATTAINED BY THE SHIFT WAS 2.18 WATTS, WHICH IS CONSIDERED AN ACCEPTABLE LEVEL OF POWER CONSUMPTION PER IFU00001 REV. 21 REQUIREMENTS. ANALYSIS OF THE PUMPS PERFORMANCE IN THE LOG FILES REVEALED PUMP PARAMETERS WITHIN NORMAL OPERATION THERE IS NO EVIDENCE TO SUGGEST A PUMP MALFUNCTION CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. HEARTWARE WILL SUBMIT A SUPPLEMENTAL REPORT WHEN NEW FACTS ARISES WHICH MATERIALLY ALTERS INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED BY CLINICAL ENGINEERING THAT THE PATIENT WAS ADMITTED TO THE HOSPITAL WITH COMPLAINTS OF NAUSEA/VOMITING (N/V), AND ABDOMINAL PAIN FOR SIX DAYS. THE PATIENT WAS PLACED ON INTRAVENOUS (IV) DIURETICS. ON (B)(6) 2015 THE PATIENT WAS TAKEN FOR RIGHT HEART CATHETERIZATION (RHC). RESULTS REVEALED ELEVATED FILLING PRESSURES AND RIGHT VENTRICULAR DYSFUNCTION. THIS PATIENT HAS A HISTORY OF LEFT VENTRICULAR NON-COMPACTION WITH FINGER-LIKE PROJECTIONS NEAR THE INFLOW CANNULA. AS A RESULT THE SITE HAS BEEN UNABLE TO RUN THE PATIENT'S PUMP SPEED HIGHER THAN 2260 RPM. THE SITE ATTRIBUTES THE PATIENT'S N/V TO THE FACT THAT THEY ARE UNABLE TO APPROPRIATELY UNLOAD THE LEFT VENTRICLE DUE TO THE NON-COMPACTION ISSUE. THE PATIENT IS CURRENTLY UNOS STATUS 1A-EXCEPTION (FOR RV FAILURE). HE WAS DISCHARGED HOME ON (B)(6) 2015 AND IS LAST REPORTED TO BE DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    23628 HEARTWARE® VENTRICULAR ASSIST SYSTEM CIRCULATORY ASSIST SYSTEM DSQ HEARTWARE, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Hospitalization| R