BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE

    MDR report key: 3202034 · Received June 27, 2013

    Report

    Report Number
    2916596-2013-00818
    Event Type
    Malfunction
    Date Received
    June 27, 2013
    Date of Event
    May 29, 2013
    Report Date
    May 29, 2013
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED EVENT OF LOW SPEED, AND PUMP STOPPAGES CAN BE CONFIRMED BASED ON THE EVALUATION OF THE REPLACED PORTION OF THE PERCUTANEOUS LEAD. A SECTION OF THE PERCUTANEOUS LEAD APPROXIMATELY 8" LONG WAS RETURNED FOR EVALUATION. THE REINFORCING SLEEVE, BIONATE, AND SHIELDING WERE REMOVED APPROXIMATELY 5.5" FROM THE CONTROLLER CONNECTOR PRIOR TO RETURN. ELECTRICAL CONTINUITY TESTING OF THE LEAD WAS PERFORMED. ALL WIRES WERE FOUND TO BE ELECTRICALLY INTACT. TAPE WAS SECURED ON THE DISTAL-END BEND RELIEF OF THE LEAD, REPAIRING A SEPARATION OF THE BEND RELIEF. THE REMAINING PORTION OF THE REINFORCING SLEEVE WAS REMOVED, AND SEVERAL AREAS OF SHIELD BREAKDOWN WERE NOTICED ADJACENT TO METAL/CONTROLLER CONNECTOR, AND AT THE REPORTED PUNCHED AREA. THE BIONATE AND SHIELDING WERE REMOVED, AND EXAMINATION OF THE WIRES REVEALED A DISRUPTION IN THE BROWN WIRE ADJACENT TO THE METAL/CONTROLLER CONNECTOR. THE CONDUCTORS OF THE BROWN WIRE WERE EXPOSED. THE REMAINING WIRES WERE INTACT, BUT EXAMINATION UNDER A MICROSCOPE REVEALED MULTIPLE MARKS CONSISTENT WITH ABRASIONS ON EACH WIRE, ADJACENT TO THE METAL/CONTROLLER CONNECTOR. THE UNDERLYING WIRES IN THE REMAINING PORTION OF THE LEAD APPEARED UNREMARKABLE INCLUDING THE REPORTED PINCHED AREA OF THE LEAD. THE DISRUPTION OF THE WIRE APPEARED TO BE CONSISTENT WITH FATIGUE AS A RESULT OF REPETITIVE FLEXING OF THE LEAD. IF THE EXPOSED CONDUCTORS OF THE BROWN WIRE CONTACTED THE BRAIDED SHIELDING WHILE OPERATING ON A TETHERED POWER SOURCE, SUCH AS THE POWER MODULE, THE RESULTING SHORT TO THE GROUND WOULD HAVE CAUSED THE REPORTED LOW SPEED AND PUMP STOPPAGES. A REVIEW OF THE DEVICE HISTORY RECORDS REVEALED NO DEVIATIONS FROM MANUFACTURING OR QA SPECIFICATIONS. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. 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). THE VAD COORDINATOR REPORTED THAT DURING THE NIGHT, THE PATIENT WAS AWAKENED BY A BEEP ON HIS SYSTEM CONTROLLER AND POWER MODULE. THE PATIENT NOTICED THAT THE DISTAL END BEND RELIEF HAD SEPARATED FROM THE METAL CONNECTOR DURING THE NIGHT. THE PATIENT CALLED VAD COORDINATOR, REPORTED THE ISSUE, AND THEN PRESENTED TO CLINIC. UPON REVIEWING THE EVENT LOG HISTORY, VAD COORDINATOR REPORTED THAT LOW SPEED AND PUMP STOP EVENTS WERE SEEN. EVENT LOG WAS SUBMITTED TO THE MANUFACTURER. EVENT LOG CONFIRMS THE EVENTS REPORTED IT IS SUSPECTED THAT THE EVENTS ARE A RESULT OF A DAMAGED PERC LEAD. THE VAD COORDINATOR BEGAN TO TROUBLESHOOT THE ISSUE TO LOCATE WHERE THE DAMAGE IS ON THE PERC LEAD. DURING TROUBLESHOOTING, VAD COORDINATOR REPORTS AN AREA ON THE EXTERNAL PERC LEAD THAT APPEARS TO HAVE BEEN PINCHED AND WHEN PINCHED, A LOW SPEED EVENT OCCURRED ON THE SYSTEM MONITOR. VAD COORDINATOR REPORTS THAT A RED HEART ALARM WAS NOT SEEN ON THE SYSTEM CONTROLLER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291892 HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 104911 105989

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention