BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM, NA

    MDR report key: 8263080 · Received January 19, 2019

    Report

    Report Number
    2916596-2019-00147
    Event Type
    Injury
    Date Received
    January 19, 2019
    Date of Event
    December 29, 2018
    Report Date
    April 24, 2019
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024011224
    PMA / PMN Number
    P060040
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION CONCLUSION: THE REPORT OF A POTENTIALLY COMPROMISED DRIVELINE CAN BE CONFIRMED. THE PUMP WAS RETURNED ASSEMBLED WITH THE DRIVELINE APPROXIMATELY 2¿ FROM THE PUMP HOUSING, WITH THREE SEPARATE PORTIONS RETURNED MEASURING 4¿, 6¿, AND 28¿, FROM THE PROXIMAL TO DISTAL END. EXAMINATION OF THE BLOOD-CONTACTING SURFACES FOUND NO ADHERED DEPOSITIONS OR THROMBUS FORMATIONS. VISUAL INSPECTION REVEALED SOME BREAKDOWN OF THE BRAIDED SHIELD APPROXIMATELY 2.5¿- 4¿ FROM THE PUMP HOUSING. THE SHIELDING AND BIONATE WERE REMOVED AND EXAMINATION OF THE UNDERLYING WIRES REVEALED A BREACH IN THE INSULATION OF THE BLACK, ORANGE AND GREEN WIRES APPROXIMATELY 4" FROM THE PROXIMAL END OF THE 6¿ SEGMENT. THE CONDUCTORS OF THE WIRES WERE EXPOSED AND THE BLACK WIRE WAS COMPLETELY SEPARATED . AN ADDITIONAL BREACH IN THE INSULATION OF THE RED WIRE WAS REVEALED APPROXIMATELY 5.5¿ FROM THE PROXIMAL END OF THE 6¿ SEGMENT. EXAMINATION OF THE WIRE SEGMENT MEASURING 4¿ REVEALED DAMAGE TO THE BIONATE AND INSULATION OF THE ORANGE AND BLACK WIRES BENEATH THAT APPEARED TO HAVE OCCURRED DURING EXPLANT. FURTHER EXAMINATION OF THE REMAINING WIRES REVEALED NO ADDITIONAL WIRE BREACHES. THE REMAINDER OF THE DRIVELINE WAS SUBMERGED IN A SALINE SOLUTION FOR HI-POT TESTING TO FURTHER VERIFY THE INTEGRITY OF EACH WIRE'S INSULATION. THIS TEST DID NOT REVEAL ANY ADDITIONAL AREAS OF CURRENT LEAKAGE. THE SEPARATION IN THE BLACK WIRE COULD HAVE CAUSED THE REPORTED DRIVELINE FAULT ALARMS. THE HMII LVAS IFU AND PATIENT HANDBOOK EXPLAIN THAT ALL HM II LVAS PERCUTANEOUS LEADS HAVE THE POTENTIAL FOR WIRE/SHIELD BREAKDOWN TO OCCUR DEPENDENT ON LENGTH OF USE AND MOVEMENT/FLEXING OVER TIME. INFORMATION REGARDING PERCUTANEOUS LEAD CARE CAN ALSO BE FOUND IN BOTH OF THESE DOCUMENTS. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 0

    SECTION EVENT: ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2019: "PATIENT LDT HAD PUMP EXCHANGE ON (B)(6) 2019 FOR DRIVELINE FRACTURE SINCE HAVE DRIVELINE FAULTS AND UNSUCCESSFUL EXTERNAL PERC LEAD REPAIR".

    Additional Manufacturer Narrative · 1

    APPROXIMATE AGE OF DEVICE- 3 YEARS, 1 MONTH. THE REPLACED PORTION OF THE PERCUTANEOUS LEAD (DRIVELINE) WAS RECEIVED FOR INVESTIGATION. THE EVALUATION IS NOT YET COMPLETE. THE PATIENT REMAINS ONGOING WITH LVAD SUPPORT. NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    THE PATIENT WAS IMPLANTED WITH LEFT VENTRICULAR ASSIST DEVICE (LVAD) ON (B)(6) 2015. IT WAS REPORTED THAT DEVICE INTERROGATION REVEALED FREQUENT DRIVELINE FAULT ALARMS. FLOW REMAINED WITHIN NORMAL LIMIT AND THERE WERE NO POWER SPIKES. THE MANUFACTURER'S TECHNICAL SERVICE REPRESENTATIVE REVIEWED THE SUBMITTED LOG FILE AND OBSERVED INTERMITTENT DRIVELINE FAULT EVENTS THAT STARTED TO OCCUR ON (B)(6) 2018. THE CUSTOMER EXCHANGED OUT THE PRIMARY SYSTEM CONTROLLER AS ADVISED BY THE TECHNICAL SERVICE REPRESENTATIVE. POST SYSTEM CONTROLLER CHANGE THE LOG FILE SHOWED THE SAME PHASE AFFECTED WITHIN THE PERCUTANEOUS LEAD (DRIVELINE), WHICH WAS AN INDICATION THAT THE DRIVELINE FAULT ALARMS WERE DUE TO A TRUE COMPROMISED WIRE. X-RAY IMAGES OF THE DRIVELINE SUBMITTED FOR REVIEW WERE MOSTLY UNREMARKABLE; HOWEVER, SHOWED THAT THE DRIVELINE AT THE PUMP END BEND RELIEF WAS POTENTIALLY WRAPPED AROUND THE PUMP HOUSING WHICH COULD CAUSE STRESS ON THE DRIVELINE. ON (B)(6) 2019, A DISTAL END DRIVELINE REPLACEMENT WAS PERFORMED. ADDITIONAL LOG FILES SUBMITTED ON (B)(6) 2019 SHOWED DRIVELINE FAULT ALARMS POST DRIVELINE REPLACEMENT; AN INDICATION THAT THE DAMAGE TO THE DRIVELINE WAS INTERNAL. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    55797 HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM, NA LEFT VENTRICULAR ASSIST SYSTEM DSQ THORATEC CORPORATION 106015 00813024011224

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other