BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTWARE® VENTRICULAR ASSIST SYSTEM

    MDR report key: 4211828 · Received October 29, 2014

    Report

    Report Number
    3007042319-2014-01150
    Event Type
    Injury
    Date Received
    October 29, 2014
    Date of Event
    June 26, 2014
    Report Date
    October 10, 2014
    Manufacturer
    HEARTWARE
    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 HVAD REMAINS IMPLANTED IN THE PATIENT, THEREFORE IT WILL NOT BE RETURNED. HOWEVER, THE CONTROLLER ((B)(4)) HAS BEEN RECEIVED AND IS AWAITING FURTHER ANALYSIS. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN THIRTY (30) DAYS OF COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    THE HEARTWARE VAD IS USED FOR TREATMENT NOT DIAGNOSIS. THE CONTROLLER WAS EXCHANGED BUT WAS NOT RETURNED TO HEARTWARE FOR EXAMINATION DESPITE MULTIPLE ATTEMPTS TO OBTAIN THE DEVICE; AS A RESULT, THE REPORTED MALFUNCTION COULD NOT BE CONFIRMED. NO HARM OR INJURY TO THE PATIENT WAS REPORTED AS A RESULT OF THIS INCIDENT. THE REPORTED CONTROLLER FAULT ALARM COULD NOT BE CONFIRMED AS CONTROLLER LOG FILES WERE NOT PROVIDED FOR ANALYSIS. EVENT DETAILS INDICATE THAT PORT 1 OF THE CONTROLLER WAS DAMAGED RESULTING IN A POOR MECHANICAL CONNECTION BETWEEN THE PORT AND THE CONNECTED POWER SOURCE. APPLICABLE RISK DOCUMENTATION AND EXPERIENCE WITH EVENTS OF SIMILAR CIRCUMSTANCES WERE CONSIDERED; EVENTS WITH DAMAGE TO CONTROLLER POWER PORTS ARE MOST OFTEN ATTRIBUTED TO THE CONTROLLER CONNECTOR BEING SUBJECTED TO A SIGNIFICANT FORCE RESULTING IN DAMAGE. THIS MAY RESULT IN AN INSECURE CONNECTION TO THE CONNECTED POWER SOURCE AND POTENTIALLY LEAD TO A LOSS OF ELECTRICAL CONTINUITY OR OTHER CONTROLLER MALFUNCTION 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. IN MAY 2015, A FIELD SAFETY NOTICE (FSCA APR2015A) WAS ISSUED TO CLINICIANS TO BE DELIVERED BY SITES TO PATIENTS CURRENTLY ON DEVICE. IT PROVIDED AWARENESS, WARNINGS, AND SAFETY MITIGATIONS REGARDING WORN ALIGNMENT GUIDES RESULTING IN BENT PINS. THE FSCA INSTRUCTED PATIENTS TO INSPECT THE POWER SUPPLY PORTS ON THEIR CONTROLLERS FOR POTENTIAL WEAR OR DAMAGE TO THE ALIGNMENT GUIDES OR CONNECTION PINS. PER THE INSTRUCTIONS FOR USE (IFU): PATIENTS ARE INSTRUCTED TO ALWAYS KEEP A BACK-UP CONTROLLER AVAILABLE AT ALL TIMES, BEYOND THE PRIMARY CONTROLLER THAT THEY ARE CURRENTLY USING. 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. DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    APPROXIMATELY ONE YEAR AND TWO MONTHS POST HEARTWARE VAD IMPLANTATION, IT WAS REPORTED THAT THE PATIENT UNDERWENT AN ELECTIVE CONTROLLER EXCHANGE AFTER EXPERIENCING SEVERAL 'CONTROLLER FAULT' ALARMS. THE EVENT WAS REPORTEDLY CAUSED DUE TO DAMAGE TO CONTROLLER POWER PORT 1 WHEREIN CONNECTED POWER SOURCES COULD NOT STAY SECURELY FASTENED. THERE WAS NO REPORTED PATIENT INJURY AS A RESULT OF THIS EVENT. INVESTIGATION IS ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    691617 HEARTWARE® VENTRICULAR ASSIST SYSTEM CIRCULATORY ASSIST SYSTEM DSQ HEARTWARE

    Patients

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