BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM, NA

    MDR report key: 8131791 · Received December 4, 2018

    Report

    Report Number
    2916596-2018-05173
    Event Type
    Injury
    Date Received
    December 4, 2018
    Date of Event
    November 11, 2018
    Report Date
    April 10, 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
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURERS INVESTIGATION RESULTS: THE REPORT OF A LOW SPEED AND PUMP STOP EVENTS CAN BE CONFIRMED BASED ON THE SUBMITTED LOG FILES THE LOG FILES CONTAINED IDENTICAL SETS OF DATA, SPANNING FROM (B)(6) 2018 08:36 TO (B)(6) 201815:08, WHICH CAPTURED NUMEROUS LOW-SPEED AND PUMP STOPS EVENTS WHILE THE PATIENT WAS SUPPORTED BY THE PATIENT CABLE AND POWER MODULE. BASED ON PAST HISTORY AND SIMILARLY REPORTED EVENTS, THE DATA CAPTURED IN THE LOG FILES IS POTENTIALLY CONSISTENT WITH A DAMAGED WIRE IN THE PATIENT¿S DRIVELINE; HOWEVER, A SPECIFIC CAUSE FOR THE LOW SPEED AND PUMP STOP EVENTS CANNOT BE CONCLUSIVELY DETERMINED THROUGH THE EVALUATION OF THE RETURNED DISTAL END OF DRIVELINE. A DISTAL END DRIVELINE REPLACEMENT WAS PERFORMED BY A TECH SERVICES REPRESENTATIVE ON (B)(6) 2018. APPROXIMATELY 17¿ OF THE EXTERNAL PORTION/DISTAL END OF THE DRIVELINE WAS RETURNED. TWO-INCH PORTIONS OF EACH WIRE WERE ALSO RETURNED. THE SILICON SLEEVE WAS REMOVED, AND EXAMINATION THE SHIELDING AND BIONATE REVEALED MULTIPLE AREAS WITH SHIELD BREAKDOWN. AN ELECTRICAL CONTINUITY TEST OF THE RETURNED DRIVELINE WAS CONDUCTED AND ALL WIRES WERE FOUND TO BE ELECTRICALLY INTACT. NO WIRE-TO-WIRE OR WIRE-TO-SHIELD SHORTS WERE INDUCED DURING THIS TESTING, EVEN WITH MANIPULATION OF THE DRIVELINE. THE SHIELDING AND BIONATE WERE REMOVED AND EXAMINATION OF THE UNDERLYING WIRES REVEALED NO EVIDENCE OF ANY BREACHES OR DAMAGE TO THE WIRE INSULATION OR UNDERLYING CONDUCTORS. THE DRIVELINE WAS SUBMERGED IN A SALINE BATH FOR HIPOT TESTING TO CHECK THE RESISTANCE OF EACH WIRE'S INSULATION. THE TEST DID NOT REVEAL ANY CURRENT LEAKAGE IN THE INSULATION OF ANY OF THE DRIVELINE WIRES THAT WOULD HAVE RESULTED IN AN ELECTRICAL SHORT. THE PATIENT REMAINS ONGOING ON VAD SUPPORT USING AN UNGROUNDED PATIENT CABLE. THE HEARTMATE II LVAS PATIENT HANDBOOK CONTAINS INFORMATION ON ¿CARING FOR THE DRIVELINE.¿ HOWEVER, ALL HMII LVAD DRIVELINES HAVE THE POTENTIAL FOR WIRE/SHIELD BREAKDOWN TO OCCUR DEPENDING UPON THE LENGTH OF USE AND MOVEMENT/FLEXING OVER TIME. THE HEARTMATE II LVAS IFU DISCUSSES DAMAGE DUE TO WEAR AND FATIGUE OF THE DRIVELINE.

    Additional Manufacturer Narrative · 0

    NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 1

    THE PATIENT WEIGHT WAS NOT PROVIDED. AGE OF DEVICE IS 3 YEARS AND 6 MONTHS. THE PATIENT REMAINS ONGOING WITH THE DEVICE. HOWEVER, A PORTION OF THE PERCUTANEOUS LEAD (DRIVELINE) IS EXPECTED TO BE RETURNED FOR EVALUATION BUT HAS NOT YET BEEN RECEIVED.

    Description of Event or Problem · 1

    THE PATIENT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD) ON (B)(6) 2015. IT WAS REPORTED THAT A PATIENT EXPERIENCED MULTIPLE PUMP OFF EVENTS FOLLOWED BY LOW FLOW ALARMS AND LOW SPEED ADVISORIES. THE LOG FILE WAS REVIEWED BY TECHNICAL SERVICES AND WAS CONFIRMED TO HAVE CAPTURED PUMP STOPS AND SPEED DROPS. PUMP STOPS, LOW FLOW ALARMS, AND LOW SPEED ADVISORIES ARE LINKED TO POTENTIAL PERCUTANEOUS LEAD DAMAGE. THESE ISSUES HAVE ONLY OCCURRED WHILE THE LVAD WAS CONNECTED TO THE POWER MODULE. THE PATIENT WAS SENT FOR PERCUTANEOUS LEAD X-RAYS, WHICH WERE UNREMARKABLE. ADDITIONALLY, ON (B)(6) 2018, TECHNICAL SERVICES ARRIVED ONSITE FOR DRIVELINE EVALUATION ABD REPAIR. A PHASE INTERRUPTER TESTS WAS PERFORMED AND NO OPEN WIRES WERE FOUND. A REPAIR WAS PERFORMED 3 INCHES FROM THE EXIT SITE. THE PERCUTANEOUS LEAD REPLACEMENT WAS COMPLETED AND PASSED ALL TESTS. AFTER THE REPAIR, THE PATIENT WAS PLACED ON A GROUNDED PATIENT CABLE WITHOUT ISSUE. ON (B)(6) 2018, THE VAD COORDINATOR REQUESTED AN UNSHIELDED PATIENT . CABLE FOR THE PATIENT. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    967919 HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM, NA LEFT VENTRICULAR ASSIST SYSTEM DSQ THORATEC CORPORATION 106015 00813024011224

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR