BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS IMPLANT KIT (WITH SEALED GRAFTS)

    MDR report key: 11902284 · Received May 28, 2021

    Report

    Report Number
    2916596-2021-02540
    Event Type
    Injury
    Date Received
    May 28, 2021
    Date of Event
    April 25, 2021
    Report Date
    July 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
    NY, US
    Reporter Occupation
    117

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: UPON EVALUATION OF HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM (LVAS), SERIAL NUMBER (B)(6) , DRIVELINE WIRE DAMAGE WAS CONFIRMED THAT WOULD HAVE CAUSED THE REPORTED PUMP STOPS WHILE THE PUMP WAS POWERED BY EXTERNAL BATTERIES, AS CONFIRMED THROUGH THE SUBMITTED LOG FILE. THE PUMP WAS RETURNED ASSEMBLED WITH THE DRIVELINE CUT APPROXIMATELY 14¿ FROM THE PUMP HOUSING, AND THE DISTAL SECTION OF THE DRIVELINE WAS RETURNED MEASURING APPROXIMATELY 24¿ WITH CONTROLLER CONNECTOR. THE OUTFLOW ELBOW WAS RETURNED ATTACHED TO 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. EXAMINATION OF THE BLOOD-CONTACTING SURFACES OF THE OUTFLOW ELBOW AND PUMP BODY UPON DISASSEMBLY REVEALED NO EVIDENCE OF LAMINATED OR DENATURED DEPOSITIONS OR THROMBUS FORMATIONS. CONTINUITY TESTING USING A DIGITAL MULTIMETER ON THE RETURNED SECTIONS OF DRIVELINE REVEALED NO SHORTS OR DISCONTINUITIES, EVEN WITH MANIPULATION OF THE DRIVELINE. MILD METAL BRAIDED SHIELD BREAKDOWN WAS NOTED AT APPROXIMATELY 2.5" AND 16.5¿ TO 19" FROM THE CONTROLLER CONNECTOR; MINOR BREAKDOWN WAS INTERMITTENTLY NOTED ALONG THE LENGTH OF THE DISTAL SECTION OF THE DRIVELINE. NO WIRE INSULATION BREACHES OR DAMAGE TO THE UNDERLYING CONNECTORS WAS NOTED ALONG THE DISTAL SECTION OF THE DRIVELINE. METAL BRAIDED SHIELD BREAKDOWN WAS NOTED AT APPROXIMATELY 13¿ FROM THE PUMP BODY ON THE PROXIMAL SECTION OF THE DRIVELINE. AT APPROXIMATELY 13.5¿ FROM THE PUMP BODY, 1 WIRE INSULATION BREACH IN THE ORANGE WIRE, 2 INSULATION BREACHES IN THE RED WIRE, AND 1 INSULATION BREACH IN THE BROWN WIRE WAS DISCOVERED. ALTHOUGH A SPECIFIC CAUSE COULD NOT CONCLUSIVELY BE DETERMINED, THE WIRE INSULATION BREACHES APPEARED CONSISTENT WITH FATIGUE DUE TO REPETITIVE FLEXING OVER TIME AND ABRASION WITH THE METAL BRAIDED SHIELD. THE LOCATION OF THE WIRE INSULATION BREACHES APPEARED TO BE AT THE DRIVELINE EXIT SIGHT. NO OTHER WIRE INSULATION BREACHES OR DAMAGE TO THE UNDERLYING CONDUCTORS WAS FOUND ON THE PROXIMAL SECTION OF THE DRIVELINE. CURRENT LEAKAGE TESTING WAS PERFORMED ON ALL RETURNED SECTIONS OF THE DRIVELINE, WHICH CONFIRMED THE WIRE INSULATION BREACHES IN THE ORANGE, RED, AND BROWN WIRES. NO FURTHER COMPROMISED WIRE INSULATION WAS DISCOVERED DURING CURRENT LEAKAGE TESTING. THE WIRE INSULATION BREACHES WOULD HAVE CAUSED THE REPORTED PUMP STOPS WHILE THE PUMP WAS CONNECTED TO EXTERNAL BATTERIES IF ANY OF THE EXPOSED CONDUCTORS FROM THE ORANGE OR RED WIRES CONTACTED THE METAL BRAIDED SHIELD AT THE SAME TIME ANY OF THE EXPOSED CONDUCTORS FROM THE BROWN WIRE CONTACTED THE METAL BRAIDED SHIELD, RESULTING IN A PHASE-TO-PHASE SHORT. THIS TYPE OF SHORT ALSO COULD HAVE RESULTED IN THE CONFIRMED PUMP STOPS IF THE EXPOSED CONDUCTORS OF EITHER THE ORANGE OR RED WIRES CONTACTED THE EXPOSED CONDUCTORS OF THE BROWN WIRE. THE PUMP UNDERWENT CLEANING AND REASSEMBLY. THE RELEVANT SECTIONS OF THE DEVICE HISTORY RECORDS FOR (B)(6) AND THE DRIVELINE, SERIAL NUMBER (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) WERE REVIEWED AND SHOWED NO DEVIATIONS FROM MANUFACTURING OR QUALITY ASSURANCE SPECIFICATIONS. THE RELEVANT SECTIONS OF THE DEVICE HISTORY RECORDS FOR THE DRIVELINE, SERIAL NUMBER 37949, WAS ALSO REVIEWED AND SHOWED NO DEVIATIONS FROM MANUFACTURING OR QUALITY ASSURANCE SPECIFICATIONS. THE IMPLANT KIT SHIPPED ON 12MAY2015. 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.

    Additional Manufacturer Narrative · 1

    THE PATIENT'S PREVIOUS DRIVELINE DAMAGE WAS CAPTURED UNDER MFR # 2916596-2020-04669. 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 WAS SEEN IN CLINIC FOR LOW SPEED ADVISORY ALARMS ON BATTERIES. A LOG FILE ANALYSIS CAPTURED 3 PUMP STOPS AND 1 LOW SPEED ADVISORY ON (B)(6) 2021. THIS TYPE OF BEHAVIOR WAS LINKED TO POTENTIAL ISSUES WITH THE PERCUTANEOUS LEAD. THESE ISSUES APPEARED TO BE OCCURRING ON BATTERIES. IT APPEARED THAT THE EXISTING SHORT TO SHIELD HAD MATURED INTO A PHASE TO PHASE SHORT. THE LOG FILE ALSO CAPTURED A FEW NO EXTERNAL POWER EVENTS ON (B)(6) 2021 THAT OCCURRED AT THE SAME TIME AS THE LOW SPEED AND PUMP STOP ALARMS. THERE WERE NO OTHER UNUSUAL EVENTS RECORDED IN THE LOG FILE. THE PATIENT WAS NOT SYMPTOMATIC AND WAS SEATED AT THE TIME OF THE EVENTS. THERE WAS NO INDICATION OF ANY REPETITIVE TORSO TWISTING CONTRIBUTIONS. THERE WAS NO SIGNIFICANT INCREASE OR DECREASE IN WEIGHT. NO NEW TRAUMA WAS NOTED TO THE DRIVELINE. THE PATIENT HAD 7 PUMP OFF EVENTS IN TWO HOURS ON (B)(6) 2021 AND WAS TRANSFERRED TO THE CARDIOVASCULAR INTENSIVE CARE UNIT. INTERNATIONAL NORMALIZED RATIO (INR) WAS REVERSED WITH VITAMIN K. THE PATIENT UNDERWENT A PUMP EXCHANGE ON (B)(6) 2021.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    799709 HEARTMATE II LVAS IMPLANT KIT (WITH SEALED GRAFTS) VENTRICULAR (ASSISST) BYPASS DSQ THORATEC CORPORATION 106015 00813024011224

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization| R