BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE II LVAS

    MDR report key: 2480961 · Received March 1, 2012

    Report

    Report Number
    2916596-2012-00194
    Event Type
    Malfunction
    Date Received
    March 1, 2012
    Date of Event
    February 3, 2012
    Report Date
    February 3, 2012
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE MFR'S TECHNICAL SVS TEAM MEMBER EVALUATED THE PT'S PERCUTANEOUS LEAD AND SUCCESSFULLY REPLACED THE COMPROMISED SECTION ON THE DISTAL END OF THE LEAD. THE PT WAS DISCHARGED HOME AND REMAINS ONGOING ON LVAD SUPPORT. EXAMINATION OF THE RETURNED PORTION OF THE PERCUTANEOUS LEAD (LEAD) THAT WAS REMOVED CONFIRMED A CUT APPROX 8" FROM THE DISTAL END THAT HAD PENETRATED THROUGH THE BIONATE AND SHIELD. THE WIRES BENEATH THE OUTER SILICONE JACKET OF THE COMPROMISED AREA REVEALED SHIELD DEFORMATION IN SEVERAL LOCATIONS ALONG THE LEAD. ELECTRICAL CONTINUITY TESTING OF THE LEAD INDICATED A SHORT BETWEEN ONE OF THE INNER WIRES AND THE SHIELD. FURTHER EVAL OF THE COMPROMISED AREA REVEALED THE INSULATIONS OF THE RED AND BROWN WIRE WERE COMPROMISED AND THE UNDERLYING CONDUCTORS OF THE RED WIRE WERE EXPOSED. SHOULD THE SHIELD HAVE COME INTO CONTACT WITH THE DISRUPTED RED WIRE INSULATION WHILE THE PT WAS BEING SUPPORTED BY THE POWER MODULE, THE RESULTING SHORT WOULD HAVE LED TO THE REPORTED PUMP STOPPAGES AND "RED HEART" ALARMS. A REVIEW OF THE DEVICE HISTORY RECORDS SHOWED NO DEVIATIONS FROM MFG OR QA SPECS. NO FURTHER INFO IS AVAILABLE. THE MFR IS CLOSING IT'S FILE ON THIS EVENT.

    Description of Event or Problem · 1

    THE PT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD). THE VAD COORD REPORTED THAT THE PT'S PERCUTANEOUS LEAD WAS DAMAGED APPROX 5" FROM THE DISTAL BEND RELIEF AND A "RED HEART" ALARM WITH PUMP STOPPAGES COULD BE INDUCED BY MANIPULATING THE LEAD. THE PICTURES TAKEN BY THE HOSP SHOWED THAT THE PERCUTANEOUS LEAD WAS APPARENTLY CUT WITH SCISSORS. THE PT WAS REPORTEDLY TAKEN TO THE OPERATING ROOM (OR) FOR A PUMP EXCHANGE. WHILE IN THE OPERATING ROOM, THE PT'S INTL NORMALIZED RATIO (INR) WAS HIGH AND A DECISION WAS MADE NOT TO PERFORM A PUMP EXCHANGE. THE SURGEON STABILIZED THE SUSPECT AREA ON THE PERCUTANEOUS LEAD WITH TONGUE DEPRESSORS WHICH REPORTEDLY STABILIZED THE PUMP SPEED AND THE MFR WAS REQUESTED TO PERFORM A PERCUTANEOUS LEAD REPAIR. THE PT REMAINED INTUBATED AWAITING REPAIR OF THE LEAD BY THE MFR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTMATE II LVAS DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 103695 100755

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Required Intervention