BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM, NA

    MDR report key: 8759772 · Received July 3, 2019

    Report

    Report Number
    2916596-2019-03020
    Event Type
    Injury
    Date Received
    July 3, 2019
    Date of Event
    June 22, 2019
    Report Date
    September 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
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: DEVICE EVALUAITON. INCIDENTAL FINDING: INCIDENTAL FINDING OF SILICONE JACKET DAMAGE OBSERVED DURING THE EVALUATION. THE EVALUATION OF THE RETURNED PORTIONS OF THE DRIVELINE CONFIRMED WIRE DAMAGE THAT WOULD HAVE CONTRIBUTED TO THE REPORTED PUMP STOP EVENTS ON THE MOBILE POWER UNIT. THE PUMP WAS RETURNED ASSEMBLED WITH THE DRIVELINE (DL) CUT APPROXIMATELY 4.5¿ FROM THE PUMP HOUSING AND THE DISTAL PORTION OF THE DL WAS RETURNED. THE INFLOW CONDUIT (INLET TUBE, FLEX SECTION, AND INLET ELBOW) WAS NOT RETURNED. THE SEALED OUTFLOW GRAFT BEND RELIEF AND OUTFLOW GRAFT WERE ALSO NOT RETURNED. THE OUTFLOW ELBOW WAS RETURNED ATTACHED TO THE PUMP¿S OUTLET PORT. THE OUTFLOW GRAFT BEND RELIEF COLLAR WAS RETURNED DISENGAGED. VISUAL EXAMINATION OF THE PUMP¿S BLOOD-CONTACTING SURFACES UPON DISASSEMBLY OF THE PUMP REVEALED NO EVIDENCE OF DEPOSITIONS OR THROMBUS FORMATIONS. A DISTAL END DRIVELINE REPLACEMENT WAS PERFORMED ON 24JUN2019 AND APPROXIMATELY 20¿ OF THE EXTERNAL PORTION/DISTAL END OF THE DRIVELINE WAS RETURNED FOR EVALUATION. ADHESIVE, TAN MEDICAL TAPE WAS OBSERVED 2¿ THROUGH 9.5¿ FROM THE METAL CONNECTOR. AN ELECTRICAL CONTINUITY TEST OF THE REPLACED DRIVELINE WAS CONDUCTED AND ALL WIRES WERE FOUND TO BE ELECTRICALLY INTACT. NO WIRE-TO-WIRE OR WIRE-TO-SHIELD ELECTRICAL SHORTS WERE INDUCED DURING THIS TESTING, EVEN WITH MANIPULATION OF THE DRIVELINE. UPON REMOVAL OF THE MEDICAL TAPE, CLEAR RESCUE TAPE WAS OBSERVED 2¿ THROUGH 5.75¿ AND 7.5¿ THROUGH 9.75¿ FROM THE METAL CONNECTOR. UPON REMOVAL OF THE RESCUE TAPE, DAMAGE TO THE SILICONE JACKET WAS OBSERVED 3.5¿, 7.75, AND 11¿ FROM THE METAL CONNECTOR (FIGURE 5). THE CLEAR BIONATE LAYER WAS DISCOLORED, BUT OTHERWISE APPEARED UNREMARKABLE. SHIELD BREAKDOWN WAS OBSERVED THROUGHOUT THE LENGTH OF THE DRIVELINE. EXAMINATION OF THE WIRES REVEALED NO EVIDENCE OF ANY BREACHES OR DAMAGE TO THE WIRE INSULATION OR UNDERLYING CONDUCTORS. THE DRIVELINE WAS THEN SUBMERGED IN A SALINE BATH FOR HIGH POTENTIAL 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. THE DRIVELINE SEGMENTS OF THE RETURNED PUMP WERE TESTED FOR ELECTRICAL CONTINUITY IN THE CONDITION THAT THEY WERE RECEIVED AND DID NOT REVEAL ANY DISCONTINUITIES. THE CLEAR BIONATE APPEARED UNREMARKABLE. SHIELD BREAKDOWN WAS OBSERVED 11.5¿ FROM THE PUMP HOUSING. VISUAL EXAMINATION OF THE UNDERLYING WIRES REVEALED A BREACH IN THE INSULATION OF THE BROWN WIRE 11.5¿ FROM THE PUMP HOUSING. THIS BREACH APPEARED CONSISTENT WITH WIRE FATIGUE AND ABRASION AGAINST THE METAL BRAIDED SHIELD. THE REMAINING WIRES APPEARED UNREMARKABLE AND WERE SUBMERGED IN A SALINE SOLUTION FOR HI-POT TESTING TO FURTHER VERIFY THE INTEGRITY OF EACH WIRE¿S INSULATION. THE TEST DID NOT REVEAL ANY ADDITIONAL BREACHES. IF THE EXPOSED CONDUCTORS OF COMPROMISED BROWN WIRE CONTACTED THE BRAIDED SHIELD WHILE THE SYSTEM WAS CONNECTED TO A TETHERED POWER SOURCE (SUCH AS THE MOBILE POWER UNIT) USING A GROUNDED PATIENT CABLE, THE RESULTING ELECTRICAL SHORT TO GROUND WOULD HAVE CAUSED THE PUMP STOP EVENTS CAPTURED IN THE SUBMITTED LOG FILES.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION: IT WAS REPORTED THAT PATIENT UNDERWENT A PUMP EXCHANGE ON (B)(6) 2019 DUE TO A SHORT TO SHIELD ISSUE. SURGERY WAS PERFORMED OFF PUMP AND THROUGH A SUB COASTAL INCISION. JUST THE PUMP MOTOR WAS EXCHANGED. NO THROMBUS WAS NOTED IN THE PUMP DURING SURGERY. PUMP AND DRIVELINE WERE RETURNED FOR ANALYSIS.

    Additional Manufacturer Narrative · 1

    THE APPROXIMATE AGE OF DEVICE: 8 MONTHS. ADDITIONAL INFORMATION WAS REQUEST, HOWEVER WAS NOT 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 A LEFT VENTRICULAR ASSIST DEVICE (LVAD) ON (B)(6) 2012. IT WAS REPORTED THAT THE PATIENT PRESENTED IN THE EMERGENCY DEPARTMENT WITH SEVERAL POWER ELEVATIONS, DECREASES IN FLOW, AND 2 PUMP STOPPAGE EVENTS. PATIENT WAS GIVEN AN UNGROUNDED POWER MODULE PATIENT CABLE UPON ADMISSION. TECHNICAL SERVICES REVIEWED THE SUBMITTED LOG FILES, AND PUMP STOPPAGES AND PUMP DECELERATIONS WERE CONFIRMED. ON (B)(4) 2019, TECHNICAL SERVICES PERFORMED A DISTAL END PERCUTANEOUS LEAD (DRIVELINE) REPLACEMENT. ON (B)(6) 2019, IT WAS REPORTED THAT THE PATIENT UNDERWENT A PUMP EXCHANGE DUE TO AN INTERNAL SHORT TO SHIELD ISSUE. THE DRIVELINE HAD SEVERAL INTERNAL TIGHT BENDS. NO THROMBUS WAS NOTED IN THE PUMP. ADDITIONAL INFORMATION WAS REQUEST, HOWEVER WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    553283 HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM, NA LEFT VENTRICULAR ASSIST SYSTEM DSQ THORATEC CORPORATION 106015 00813024011224

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Hospitalization| R