BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS, EUROPE

    MDR report key: 4132856 · Received September 29, 2014

    Report

    Report Number
    2916596-2014-01714
    Event Type
    Injury
    Date Received
    September 29, 2014
    Date of Event
    September 1, 2014
    Report Date
    September 1, 2014
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT REMAINS ON LVAD SUPPORT WITH THE REPLACEMENT PUMP. THE MANUFACTURER IS ATTEMPTING TO ACQUIRE THE EXPLANTED PUMP FOR ANALYSIS. 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 DEVICE CONFIRMED INTERNAL PERCUTANEOUS LEAD (LEAD) WIRE DAMAGE THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. THE PUMP WAS RETURNED ASSEMBLED WITH THE PERCUTANEOUS LEAD CUT APPROXIMATELY 1¿ FROM THE PUMP HOUSING AND THE DISTAL PORTION OF THE LEAD WAS RETURNED. THE INFLOW CONDUIT (INLET TUBE, FLEX SECTION, AND INLET ELBOW), THE OUTFLOW GRAFT, AND THE OUTFLOW GRAFT BEND RELIEF WERE NOT RETURNED. THE OUTFLOW ELBOW WAS RETURNED ATTACHED TO THE PUMP¿S OUTLET PORT. ANALYSIS OF THE OUTFLOW ELBOW REVEALED NO EVIDENCE OF DEPOSITIONS OR THROMBUS FORMATIONS. VISUAL EXAMINATION OF THE PUMP¿S BLOOD-CONTACTING SURFACES UPON DISASSEMBLY REVEALED NO EVIDENCE OF DEPOSITIONS OR THROMBUS FORMATIONS. THE DISASSEMBLED PUMP¿S BEARINGS, ROTOR, AND BLOOD-CONTACTING SURFACES WERE EXAMINED UNDER A MICROSCOPE AND NO ANOMALIES WERE OBSERVED. ALTHOUGH A SHORT WAS CONFIRMED AT THE TIME OF THE PERCUTANEOUS LEAD EXAMINATION, THE RETURNED PERCUTANEOUS LEAD WAS TESTED FOR ELECTRICAL CONTINUITY IN THE CONDITION THAT IT WAS RECEIVED AND DID NOT REVEAL ANY DISCONTINUITIES OR SHORTS. THE WHITE SILICONE JACKET WAS REMOVED AND AN EVALUATION OF THE METAL BRAIDED SHIELD SHOWED THINNING INDICATIVE OF NORMAL WEAR FOR THE LEAD¿S DURATION OF USE. THE PINS OF THE METAL CONNECTOR WERE FREE FROM DEFORMATION. THE CLEAR BIONATE AND METAL BRAIDED SHIELD WERE THEN REMOVED TO EXAMINE THE UNDERLYING WIRES. VISUAL INSPECTION OF THE WIRES REVEALED A BREACH IN THE INSULATION OF THE YELLOW WIRE, APPROXIMATELY 32.5 INCHES FROM THE METAL CONNECTOR, EXPOSING THE INNER CONDUCTORS; THE YELLOW WIRE REDUNDANTLY SUPPORTS MOTOR PHASE 1. THE OBSERVED WIRE DAMAGE APPEARED TO BE THE RESULT OF REPETITIVE FLEXING. ABRASIONS TO THE INSULATION OF THE REMAINING WIRES WERE NOTED, BUT THE REMAINDER OF THE LEAD WAS OTHERWISE UNREMARKABLE. IF THE EXPOSED CONDUCTORS OF THE YELLOW WIRE CONTACTED THE BRAIDED SHIELD WHILE OPERATING ON A TETHERED POWER SOURCE, SUCH AS THE POWER MODULE, THE RESULTING SHORT TO GROUND WOULD HAVE RESULTED IN THE ALARMS THAT WERE CONFIRMED THROUGH THE EVALUATION OF THE SYSTEM CONTROLLER DATA LOG FILE. A REVIEW OF DEVICE HISTORY RECORDS SHOWED NO DEVIATIONS FROM MANUFACTURING OR QA SPECIFICATIONS. NO FURTHER INFORMATION IS AVAILABLE. 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 6 YEARS POST IMPLANT IT WAS REPORTED THAT THE PATIENT HAD LOW SPEED ALARMS WHEN CONNECTED TO THE POWER MODULE. THE PATIENT ALSO REPORTED FEELING A "RUMBLE" FROM THE PUMP. THE PATIENT RETURNED TO THE IMPLANT CENTER FOR EVALUATION. X-RAYS WERE TAKEN AND A REVIEW OF THE PATIENT'S EVENT HISTORY WAS PERFORMED. THE PATIENT WAS STABLE ON BATTERIES AND THE HOSPITAL REQUESTED A NON-GROUNDED POWER MODULE PATIENT CABLE. EXAMINATION OF THE PERCUTANEOUS LEAD WAS PERFORMED AND INDICATED THAT REPAIRS HAD BEEN APPLIED AT THE DISTAL END NEAR THE SYSTEM CONTROLLER CONNECTOR. IN ADDITION, A SHORT TO SHIELD ABOUT 4 INCHES FROM THE EXIT SITE IN THE VELOUR AREA OF THE DRIVELINE WAS SUSPECTED, THEREFORE, THE PATIENT RECEIVED A PUMP EXCHANGE ON (B)(6) 2014. ADDITIONAL INFORMATION RECEIVED FROM A USER FACILITY REPORT INDICATED THAT EXAMINATION, DONE BY THE HOSPITAL, OF THE EXPLANTED PUMP SHOWED DAMAGED SHIELDING OVER A PORTION OF THE PERCUTANEOUS LEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    606870 HEARTMATE II LVAS, EUROPE LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 102139 71889

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Required Intervention