BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE II LVAS IMPLANT KIT (WITH SEALED GRAFTS)

    MDR report key: 12097648 · Received July 1, 2021

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    Report

    Report Number
    2916596-2021-03193
    Event Type
    Malfunction
    Date Received
    July 1, 2021
    Date of Event
    May 19, 2021
    Report Date
    September 30, 2021
    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

    NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETED.

    Additional Manufacturer Narrative · 0

    SECTION D9: THE PERCUTANEOUS LEAD WAS RETURNED ON 22JUL2021. THE PUMP WAS RETURNED ON 27JUL2021. INCIDENTAL FINDINGS: INVESTIGATION OF THE RETURNED EXTERNAL DRIVELINE FOUND TEARS IN THE SILICONE JACKET. MANUFACTURER'S INVESTIGATION CONCLUSION: UPON EVALUATION OF HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM (LVAS), (B)(6) , INTERNAL WIRE DAMAGE BETWEEN THE PUMP BEND RELIEF AND DRIVELINE EXIT SITE WAS CONFIRMED THAT WOULD HAVE CAUSED THE DRIVELINE FAULT ALARM, AS CAPTURED IN THE SUBMITTED LOG FILES. A DRIVELINE REPAIR WAS PERFORMED ON (B)(6) 2021. APPROXIMATELY 21¿ OF THE REPLACED, EXTERNAL DRIVELINE WAS RETURNED WITH TAPE AROUND SECTIONS OF THE SILICONE JACKET. AN ELECTRICAL CONTINUITY TEST OF THE REPLACED, EXTERNAL DRIVELINE WAS CONDUCTED, AND ALL WIRES WERE FOUND TO BE ELECTRICALLY INTACT. UPON REMOVAL OF THE TAPE, MULTIPLE SMALL TEARS IN THE SILICONE JACKET WERE INTERMITTENTLY DISCOVERED ALONG APPROXIMATELY 2.5-4.5¿ AND 10.0-14.0¿ FROM THE CONTROLLER CONNECTOR. SEVERE METAL BRAIDED SHIELD BREAKDOWN WAS NOTED ALONG THE RETURNED SECTION OF DRIVELINE. EXAMINATION OF THE UNDERLYING WIRES REVEALED NO EVIDENCE OF ANY BREACHES OR DAMAGE TO THE WIRE INSULATION OR UNDERLYING CONDUCTORS THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. THE DRIVELINE WAS SUBMERGED IN A SALINE BATH FOR HI-POT TESTING AND NO AREAS OF CURRENT LEAKAGE THROUGH THE INSULATION OF THE DRIVELINE¿S WIRES WERE IDENTIFIED THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. THE PATIENT UNDERWENT A PUMP EXCHANGE FROM (B)(6) TO (B)(6) ON (B)(6) 2021. (B)(6) WAS RETURNED ASSEMBLED WITH THE DRIVELINE CUT APPROXIMATELY 15¿ FROM THE PUMP HOUSING, AND THE DISTAL PORTION OF THE DRIVELINE WAS RETURNED MEASURING APPROXIMATELY 23¿ WITH A DRIVELINE REPAIR AT APPROXIMATELY 21¿ FROM THE CONTROLLER CONNECTOR. THE OUTFLOW ELBOW WAS RETURNED DISCONNECTED FROM THE PUMP OUTLET PORT. THE SEALED INFLOW CONDUIT, APICAL SEWING RING, SEALED OUTFLOW GRAFT, SEALED OUTFLOW GRAFT BEND RELIEF (OGBR), AND SEALED OGBR COLLAR WERE NOT RETURNED. UPON DISASSEMBLY OF THE PUMP BODY, VISUAL INSPECTION OF THE PUMP¿S BLOOD-CONTACTING SURFACES REVEALED NO EVIDENCE OF ADHERED DEPOSITIONS OR THROMBUS FORMATIONS. UPON EVALUATION OF THE DRIVELINE RETURNED WITH (B)(6) , THE SILICONE JACKET WAS FOUND TO BE UNREMARKABLE. ELECTRICAL CONTINUITY TESTING ON THE DISTAL SECTION OF DRIVELINE REVEALED NO SHORTS OR DISCONTINUITIES. THE CONTROLLER CONNECTOR, METAL BRAIDED SHIELD LAYER, DRIVELINE REPAIR, AND THE UNDERLYING WIRES OF THE DISTAL SECTION OF DRIVELINE APPEARED UNREMARKABLE. THE DISTAL SECTION OF DRIVELINE WAS SUBMERGED IN A SALINE BATH FOR HI-POT TESTING AND NO AREAS OF CURRENT LEAKAGE THROUGH THE INSULATION OF THE DRIVELINE¿S WIRES WERE IDENTIFIED. ELECTRICAL CONTINUITY TESTING ON THE PROXIMAL SECTION OF DRIVELINE, CONNECTED TO THE PUMP, FOUND THAT THE RED WIRE FAILED CONTINUITY TESTING WITH MANIPULATION OF THE DRIVELINE. CONTINUITY TESTING ON THE REMAINING WIRES REVEALED NO SHORTS OR DISCONTINUITIES. MODERATE TO SEVERE METAL BRAIDED SHIELD BREAKDOWN WAS NOTED. EXAMINATION OF THE UNDERLYING WIRES REVEALED DAMAGED CONDUCTORS AND WIRE INSULATION OF THE RED WIRE AND INSULATION BREACHES OF THE YELLOW, ORANGE, BROWN, AND GREEN WIRES APPROXIMATELY 9¿ FROM THE PUMP BODY. THE PROXIMAL SECTION OF DRIVELINE WAS SUBMERGED IN A SALINE BATH FOR HI-POT TESTING WHICH CONFIRMED THE WIRE INSULATION BREACHES. NO OTHER AREAS OF CURRENT LEAKAGE THROUGH THE INSULATION OF THE DRIVELINE¿S WIRES WERE IDENTIFIED. THE WIRE CONDUCTOR AND WIRE INSULATION DAMAGE APPEARED CONSISTENT WITH DRIVELINE DAMAGE DUE TO REPETITIVE FLEXING OVER TIME AND ABRASION OF THE METAL BRAIDED SHIELD. THE DAMAGE TO THE RED WIRE CONDUCTORS WOULD HAVE CAUSED THE REPORTED DRIVELINE FAULTS. THE RELEVANT SECTIONS OF THE DEVICE HISTORY RECORDS FOR (B)(6) AND THE DRIVELINE, (B)(6) , WERE REVIEWED AND SHOWED NO DEVIATIONS FROM MANUFACTURING OR QUALITY ASSURANCE SPECIFICATIONS. THE RELEVANT SECTIONS OF THE DEVICE HISTORY RECORDS FOR (B)(6) AND THE DRIVELINE, (B)(6) WERE REVIEWED AND SHOWED NO DEVIATIONS FROM MANUFACTURING OR QUALITY ASSURANCE SPECIFICATIONS. THE IMPLANT KIT SHIPPED ON 04OCT2013. THE HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM (LVAS) INSTRUCTIONS FOR USE (IFU) IS CURRENTLY AVAILABLE. SECTION 6 ¿PATIENT CARE AND MANAGEMENT¿ DISCUSSES DAMAGE DUE TO WEAR AND FATIGUE OF THE DRIVELINE. THIS SECTION ALSO CONTAINS INFORMATION ON ¿CARING FOR THE DRIVELINE¿ (UNDER ¿ONGOING SYSTEM ASSESSMENT AND CARE¿) AND PROVIDES POSSIBLE INDICATIONS OF DRIVELINE DAMAGE AS WELL AS HOW TO RESPOND TO SUCH EVENTS. SECTION 7 "ALARMS AND TROUBLESHOOTING" OUTLINES ALL SYSTEM CONTROLLER ALARMS AS WELL AS HOW TO RESPOND TO EACH ALARM CONDITION. SECTION 8 ¿EQUIPMENT STORAGE AND CARE¿ ALSO CONTAINS INFORMATION ON ¿CARE OF THE DRIVELINE,¿ AND PROVIDES POSSIBLE INDICATIONS OF DRIVELINE DAMAGE. THE HEARTMATE II LVAS PATIENT HANDBOOK IS ALSO CURRENTLY AVAILABLE. SECTION 4 ¿LIVING WITH THE HEARTMATE II¿ CONTAINS INFORMATION ON CARING FOR THE DRIVELINE. SECTION 5 "ALARMS AND TROUBLESHOOTING" OUTLINES ALL SYSTEM CONTROLLER ALARMS AS WELL AS HOW TO RESPOND TO EACH ALARM CONDITION. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT'S CONTROLLER WAS EXCHANGED. ADDITIONAL INFORMATION REPORTED THAT 2 X-RAYS OF THE PATIENT'S DRIVELINE (DL). THE PAPERCLIP INDICATED THE DRIVELINE EXIT POINT. THE EXTERNAL IMAGE IS UNREMARKABLE. THE INTERNAL IMAGE SHOWS A LOOP NEAR THE PUMP END BEND RELIEF WHICH MAY STRESS THE DRIVELINE. A PERCUTANEOUS LEAD (DRIVELINE) REPLACEMENT (PLR) WAS PERFORMED ON (B)(6) 2021. THE DRIVELINE DEBUG DATA DID NOT IMPROVE POST THE PLR. THE REMOVED SECTION OF THE PERCUTANEOUS LEAD WAS RETURNED FOR EVALUATION. ADDITIONAL LOG FILE SUBMITTED REVEALED A DRIVELINE FAULT AT 0420 AND 0449 MORNING OF 22JUL2021 IN THE LVAD HISTORY. THE PHASE DATA CONTINUES TO SHOW DEGRADATION IN THE RED WIRE INDICATING THAT THE CURRENT REPAIR WAS NOT SUCCESSFUL IN REMOVING THE DAMAGED AREA. ON (B)(6) 2021, THE PATIENT UNDERWENT A PUMP EXCHANGE. NO ADDITIONAL INFORMATION PROVIDED. RELATED MANUFACTURER REPORT NUMBER: 2916596-2021-04381.

    Additional Manufacturer Narrative · 1

    NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER¿S INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD MULTIPLE DRIVELINE FAULT ALARMS. THE LOG FILE CAPTURED DRIVELINE FAULT ALARMS STARTING ON (B)(6) 2021 AND CONTINUED INTERMITTENTLY FOR THE REMAINDER OF THE LOG FILE. IT WAS RECOMMENDED TO CHANGE THE CONTROLLER TO COMPARE DRIVELINE WIRE VALUES. ADDITIONAL INFORMATION WAS REQUESTED BUT NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    994699 HEARTMATE II LVAS IMPLANT KIT (WITH SEALED GRAFTS) VENTRICULAR (ASSISST) BYPASS DSQ THORATEC CORPORATION 106015 00813024011224

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention