BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS, EUROPE

    MDR report key: 4820291 · Received June 4, 2015

    Report

    Report Number
    2916596-2015-01035
    Event Type
    Injury
    Date Received
    June 4, 2015
    Date of Event
    May 7, 2015
    Report Date
    May 7, 2015
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE APPROXIMATE AGE OF THE DEVICE IS 3 YEARS AND 3 MONTHS. THE PUMP REMAINS IN USE SUPPORTING THE PATIENT. NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETED. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    (B)(4). NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER''S INVESTIGATION IS COMPLETED.

    Additional Manufacturer Narrative · 1

    THE EVALUATION OF THE HEARTMATE II LVAD, SERIAL NUMBER (B)(4), CONFIRMED INTERNAL PERCUTANEOUS LEAD (LEAD) WIRE DAMAGE THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. THE PUMP WAS RETURNED ASSEMBLED WITH THE LEAD CUT APPROXIMATELY 7.5 INCHES FROM THE PUMP HOUSING AND THE DISTAL PORTION OF THE LEAD, AS WELL AS THE SECTION OF LEAD FROM THE ATTEMPTED DISTAL END REPLACEMENT, WAS ALSO RETURNED. EVIDENCE OF THE REPORTED REPAIR OF THE SILICONE JACKET OF THE LEAD WITH RESCUE TAPE WAS OBSERVED. THE LEAD WAS TESTED FOR ELECTRICAL CONTINUITY IN THE CONDITION THAT IT WAS RECEIVED AND THE ORANGE WIRE AT THE PUMP-END OF THE DEVICE PRODUCED AN OPEN CIRCUIT. VISUAL INSPECTION OF THE LEAD CONFIRMED THAT THE ORANGE WIRE WAS SEVERED AT THE PUMP¿S NIPPLE HOUSING. BREACHES TO THE INSULATION OF THE BLACK AND GREEN WIRES WERE ALSO OBSERVED IN THIS AREA, EXPOSING THE INNER CONDUCTORS. THE OBSERVED WIRE DAMAGE APPEARED TO BE THE RESULT OF REPETITIVE MOVEMENT OF THE LEAD DURING SUPPORT. THE REMAINING WIRES WERE ABRADED, BUT WERE OTHERWISE UNREMARKABLE. A REVIEW OF DEVICE HISTORY RECORDS SHOWED NO DEVIATIONS FROM MANUFACTURING OR QUALITY ASSURANCE SPECIFICATIONS. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING ITS FILE ON THIS EVENT.

    Description of Event or Problem · 1

    THE PATIENT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD). APPROXIMATELY 3 YEARS AND 3 MONTHS POST-IMPLANT, IT WAS REPORTED THAT THE PATIENT EXPERIENCED A LOW SPEED/LOW VOLTAGE ALARM DURING THE NIGHT AND RETURNED TO THE HOSPITAL. THE CARDIOLOGIST REVIEWED THE PATIENT¿S SYSTEM CONTROLLER EVENT HISTORY AND REDUCTIONS IN PUMP SPEED TO 3000 RPMS WERE SEEN TWICE. AN X-RAY WAS PERFORMED THAT INDICATED DRIVELINE DAMAGE. THE PATIENT WAS ASYMPTOMATIC DURING THE EVENT AND WAS PLACED ON BATTERY SUPPORT. APPROXIMATELY 4 DAYS LATER, THE MANUFACTURER¿S TECHNICAL SERVICE PERSONNEL INSPECTED THE PATIENT¿S DRIVELINE AND NO INDICATION OF WIRE BREAKS WERE SEEN AND LOW SPEED EVENTS WERE UNABLE TO BE REPLICATED. A NON-GROUNDED PATIENT CABLE WAS PROVIDED AND THE PATENT'S SYSTEM CONTROLLER AND POWER MODULE PATIENT CABLE WERE REPLACED. NO ADDITIONAL INFORMATION WAS AVAILABLE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT DURING A SECOND DRIVELINE EVALUATION, A DRIVELINE REPAIR WAS ATTEMPTED BUT WAS UNABLE TO BE COMPLETED. AFTER THE FIRST THREE WIRES WERE CONNECTED TO THE NEW DRIVELINE DURING THE REPAIR PROCESS, THE PUMP FAILED TO START WHEN CONNECTED TO THE SYSTEM CONTROLLER. THE PATIENT UNDERWENT A PUMP EXCHANGE THAT DAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    360948 HEARTMATE II LVAS, EUROPE LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention