BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTWARE® VENTRICULAR ASSIST SYSTEM

    MDR report key: 3914040 · Received July 3, 2014

    Report

    Report Number
    3007042319-2014-00672
    Event Type
    Injury
    Date Received
    July 3, 2014
    Date of Event
    June 6, 2014
    Report Date
    June 6, 2014
    Manufacturer
    HEARTWARE, INC
    Product Code
    DSQ
    PMA / PMN Number
    P100047
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    OTHER

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    THE HVAD IS USED FOR TREATMENT NOT DIAGNOSIS. IT WAS REPORTED THAT THE PATIENT DEVELOPED INADEQUATE FLOW RATE FOLLOWING ROUTINE RIGHT HEART CATHETERIZATION. COMPUTERIZED TOMOGRAPHY (CT) IMAGING CONFIRMED OBSTRUCTION OF THE OUTFLOW GRAFT. THE OUTFLOW GRAFT WAS STENTED A TOTAL OF TWO (2) TIMES WITH A RESULTING IMPROVEMENT IN FLOW. THE PATIENT ALSO EXPERIENCED A CEREBROVASCULAR ACCIDENT DURING HER ADMISSION. THE DEVICES WERE NOT RETURNED TO THE MANUFACTURER FOR EVALUATION, HOWEVER, REVIEW OF THE MANUFACTURING RECORDS INDICATED THAT THESE UNITS MET ALL THE INTERNAL REQUIREMENTS PRIOR TO ITS RELEASE PROCESS. THE REPORTED EVENT COULD NOT BE CONFIRMED VIA CONTROLLER LOG FILES AS THEY WERE AVAILABLE FOR ANALYSIS. THE MOST PROBABLE ROOT CAUSE FOR THE REPORTED "INADEQUATE FLOW RATE" EVENT MAY BE ATTRIBUTED TO AN OUTFLOW GRAFT OBSTRUCTION. 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 PUMP IS A FIXED SPEED SYSTEM. LOW FLOW, AVERAGE FLOW BELOW THE ALARM THRESHOLD, MAY BE RELATED TO POOR VAD FILLING. THE INSTRUCTIONS FOR USE ADDRESSES SETTING OF PARAMETERS FOR FLOW, POWER AND WATTS. GUIDELINES FOR POTENTIAL CAUSES OF ALARMS, ASSESSMENT OF THE PATIENT AND DEVICE STATUS ALONG WITH RELATED POTENTIAL CAUSES WHICH CAN INCLUDE RIGHT VENTRICULAR FAILURE, HYPOVOLEMIA, TAMPONADE, ARRHYTHMIAS, HIGH BLOOD PRESSURE, INFLOW CANNULA OBSTRUCTION, OUTFLOW GRAFT KINK ARE OUTLINED ALONG WITH POTENTIAL ACTIONS TO TAKE. 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.

    Description of Event or Problem · 1

    APPROXIMATELY THREE AND A HALF YEARS AFTER IMPLANT, THIS PATIENT DEVELOPED LOW PUMP WATTS AND FLOWS FOLLOWING ELECTIVE RIGHT HEART CATHETERIZATION. THEY WERE ADMITTED TO THE INTENSIVE CARE UNIT (ICU) AND TREATED WITH INOTROPES AND VASOPRESSORS. CT IMAGING CONFIRMED OUTFLOW OBSTRUCTION AND THEY WERE RETURNED TO THE CARDIAC CATHETERIZATION LABORATORY FOR OUTFLOW GRAFT STENTING. STENTING OF THE PROXIMAL, MID AND DISTAL PORTIONS OF THE GRAFT DID NOT YIELD ANY IMPROVEMENTS IN PUMP FLOW; HOWEVER, STENTING AT THE AORTIC ANASTOMOSIS DID RETURN PUMP FLOWS TO BASELINE LEVELS. FOLLOWING THE PROCEDURE THE PATIENT WAS TRANSFERRED BACK TO THE ICU AND LISTED AS STATUS 1A FOR TRANSPLANT. INVESTIGATION IS ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    390958 HEARTWARE® VENTRICULAR ASSIST SYSTEM CIRCULATORY ASSIST SYSTEM DSQ HEARTWARE, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R