BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE

    MDR report key: 3964364 · Received June 19, 2014

    Report

    Report Number
    2916596-2014-01020
    Event Type
    Malfunction
    Date Received
    June 19, 2014
    Date of Event
    May 20, 2014
    Report Date
    May 20, 2014
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO FURTHER INFO IS AVAILABLE AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MFR'S INVESTIGATION IS COMPLETED.

    Additional Manufacturer Narrative · 1

    THE X-RAY IMAGES OF THE INTERNAL AND EXTERNAL PORTIONS OF THE PERCUTANEOUS LEAD PROVIDED TO THE MANUFACTURER FOR ANALYSIS AT THE TIME OF THE EVENT APPEARED UNREMARKABLE. THE PUMP REMAINS IN USE SUPPORTING THE PATIENT; HOWEVER, APPROXIMATELY 7¿ OF THE EXTERNAL PORTION/DISTAL END OF THE LEAD THAT WAS REMOVED DURING THE REPAIR WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. ELECTRICAL CONTINUITY TESTING OF THE RETURNED EXTERNAL PORTION OF THE LEAD FOUND THAT THE BLACK WIRE WITHIN THE LEAD WAS OPEN. BREAKDOWN OF THE BRAIDED SHIELD WAS NOTED ADJACENT TO THE METAL CONNECTOR. REMOVAL OF THE CLEAR BIONATE AND BRAIDED SHIELD LAYERS UNDERNEATH THE SILICONE JACKET OF THE LEAD REVEALED THAT THE BLACK WIRE HAD FRACTURED ADJACENT TO THE METAL CONNECTOR. THE OBSERVED WIRE DAMAGE APPEARED TO BE THE RESULT OF FATIGUE DUE TO REPETITIVE MOVEMENT DURING USE. IF THE EXPOSED CONDUCTORS OF THE FRACTURED BLACK WIRE CONTACTED THE BRAIDED SHIELD WHILE THE PUMP WAS OPERATING ON TETHERED POWER, SUCH AS THE POWER MODULE, THE RESULTING ELECTRICAL SHORT TO GROUND COULD HAVE CAUSED THE REPORTED LOW SPEED AND PUMP STOPPAGE EVENTS. A REVIEW OF THE PUMP DEVICE HISTORY RECORDS SHOWED NO DEVIATIONS FROM MANUFACTURING OR QA SPECIFICATIONS. THE PATIENT HANDBOOK CONTAINS A SECTION ON ¿CARING FOR THE PERCUTANEOUS LEAD" AND IN ADDITION, THE DEVICE¿S APPROVED LABELING STATES ALL LVAD PERCUTANEOUS LEADS HAVE THE POTENTIAL FOR WIRE/SHIELD BREAKDOWN TO OCCUR DEPENDENT UPON LENGTH OF USE AND PATIENT HANDLING. NO FURTHER INFORMATION IS AVAILABLE. THE MANUFACTURER IS CLOSING ITS FILE ON THIS EVENT.

    Description of Event or Problem · 1

    THE PT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD). THE VAS COORDINATOR SUBMITTED A LOG FILE THAT REVEALED SPEED DROPS BELOW THE AUTO LOW SETTING WHILE THE PT WAS HOOKED UP TO THE POWER MODULE. RED HEART ALARMS WERE NOTED. X-RAYS WERE REQUESTED. ADD'L INFO RECEIVED ON (B)(4) 2014 THAT A DISTAL END PERCUTANEOUS LEAD REPLACEMENT WAS PERFORMED AND SUCCESSFUL. IT WAS COMPLETED ON (B)(6) 2014 BY THE MFR'S TECHNICAL SERVICES TEAM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    359353 HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 104911 124668

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention