BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE II LVAS IMPLANT KIT (WITH SEALED GRAFTS)

    MDR report key: 13476345 · Received February 7, 2022

    Report

    Report Number
    2916596-2022-00523
    Event Type
    Malfunction
    Date Received
    February 7, 2022
    Date of Event
    January 16, 2022
    Report Date
    March 22, 2022
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024011170
    PMA / PMN Number
    P060040
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    HISTORY OF DRIVELINE DAMAGE PREVIOUSLY MENTION IN INITIAL REPORT IS REPORTED UNDER MFR# 2916596-2022-00509 MANUFACTURER'S INVESTIGATION CONCLUSION: THERE WERE INCIDENTAL FINDINGS OF SUPERFICIAL SILICONE SLEEVE DAMAGE. EVALUATION OF THE RETURNED PORTION OF DRIVELINE CONFIRMED A COMPROMISED WIRE THAT COULD HAVE CONTRIBUTED TO THE LOW SPEED AND PUMP STOP EVENTS OBSERVED IN THE SUBMITTED LOG FILE. A DISTAL-END DRIVELINE REPLACEMENT WAS PERFORMED ON (B)(6) 2022 UNDER AND APPROXIMATELY 19.5¿ OF THE EXTERNAL PORTION/DISTAL-END OF THE DRIVELINE WAS RETURNED FOR EVALUATION. AN ELECTRICAL CONTINUITY TEST WAS PERFORMED TO THE DISTAL-END DRIVELINE IN THE CONDITION THAT IT WAS RECEIVED AND DID NOT REVEAL ANY DISCONTINUITIES OR SHORTS. THE DRIVELINE WAS RETURNED COVERED IN TAPE ALONG THE LENGTH OF THE DRIVELINE. THE SILICONE SLEEVE AND TAPE WERE REMOVED AND REVEALED DISCOLORATION TO THE BIONATE LAYER APPROXIMATELY 5.75¿-11¿ FROM THE METAL CONNECTOR. THE BIONATE WAS REMOVED AND FRAYING AND MINOR BREAKDOWN IN THE METAL BRAIDED SHIELD WAS OBSERVED ALONG THE LENGTH OF THE DRIVELINE WITH A NOTABLY LARGER AREA OF BREAKDOWN APPROXIMATELY 5.25¿ FROM THE METAL CONNECTOR. VISUAL INSPECTION OF THE UNDERLYING WIRES REVEALED A KINK TO THE UNDERLYING WIRES APPROXIMATELY 9¿ FROM THE METAL CONNECTOR. FURTHER INSPECTION OF THE KINK CONFIRMED WEAR IN THE INSULATION OF THE YELLOW WIRE APPROXIMATELY 9¿ FROM THE METAL CONNECTOR AT THE LOCATION OF THE KINK. THE UNDERLYING WIRES OF THE DRIVELINE WERE THEN SUBMERGED IN A SALINE SOLUTION FOR HIGH POTENTIAL TESTING TO VERIFY THE INTEGRITY OF EACH WIRE¿S INSULATION. THIS TEST DID NOT REVEAL ANY ADDITIONAL AREAS OF CURRENT LEAKAGE. IF THE EXPOSED CONDUCTORS OF THE YELLOW WIRE CONTACTED THE BRAIDED SHIELD WHILE OPERATING ON A TETHERED POWER SOURCE SUCH AS THE POWER MODULE OR MOBILE POWER UNIT (MPU), THE RESULTING SHORT TO GROUND COULD HAVE RESULTED IN THE ALARMS AND PUMP STOPS THAT WERE CONFIRMED THROUGH THE SUBMITTED LOG FILE. IT WAS LATER REPORTED THAT THE PATIENT EXPERIENCED FURTHER PUMP STOP EVENTS. THE PATIENT REMAINS ONGOING ON HEARTMATE II LVAS, SERIAL NUMBER (B)(6). THE RELEVANT SECTIONS OF THE DEVICE HISTORY RECORDS FOR (B)(6) AND DRIVELINE (B)(6) WERE REVIEWED AND SHOWED NO DEVIATIONS FROM MANUFACTURING OR QUALITY ASSURANCE SPECIFICATIONS. THE LVAS KIT WAS SHIPPED ON 24OCT2012. THE HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM (LVAS) INSTRUCTIONS FOR USE (IFU) IS CURRENTLY AVAILABLE. PUMP SPEED, POWER, FLOW, AND PULSATILITY INDEX (PI) ARE ALSO ADDRESSED IN SECTION 1 OF THIS IFU. THE SECTION ENTITLED "ALARMS AND TROUBLESHOOTING" OUTLINES ALL SYSTEM CONTROLLER ALARMS AND HOW TO RESPOND TO EACH ALARM CONDITION. THIS IFU ALSO OUTLINES THE INDICATIONS OF DRIVELINE DAMAGE, AS WELL AS HOW TO RESPOND TO SUCH EVENTS. THE IFU ADVISES THE PATIENT TO CHECK THE DRIVELINE FOR SIGNS OF DAMAGE, SUCH AS CUTS, HOLES, OR TEARS. THE HEARTMATE II LVAS PATIENT HANDBOOK IS ALSO CURRENTLY AVAILABLE. THE ¿ALARMS AND TROUBLESHOOTING¿ SECTION CONTAINS INFORMATION REGARDING SYSTEM CONTROLLER ALARMS AND THE PROPER ACTIONS ASSOCIATED WITH THEM. THIS HANDBOOK ALSO CONTAINS A SECTION ON ¿CARING FOR THE DRIVELINE¿ ¿ HOWEVER, ALL HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE (LVAD) PERCUTANEOUS LEADS HAVE THE POTENTIAL FOR WIRE/SHIELD BREAKDOWN TO OCCUR DEPENDENT UPON LENGTH OF USE MOVEMENT/FLEXING OVER TIME. NO FURTHER INFORMATION PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ON (B)(6) 2022 THE PATIENT CHANGED POWER SOURCES FROM BATTERY POWER TO THEIR MOBILE POWER UNIT (MPU) AND THAT ALARMS SUBSEQUENTLY OCCURRED UPON THE PATIENT LYING DOWN FOR BED. THE ALARM WAS NOT VISIBLE TO THE PATIENT AND THE PATIENT TRANSITIONED BACK TO BATTERY POWER WHICH CAUSED THE ALARM TO CEASE. THE PATIENT TRIED TO REPLICATE THE ALARM A COUPLE TIMES BY SWITCHING FROM BATTERY POWER TO MPU AND THEN LYING DOWN. EACH TIME THE PATIENT LIED DOWN THE ALARM RECURRED. THE FOLLOWING MORNING THE PATIENT AGAIN ATTEMPTED TO SIMULATE THE ALARMS, AND THE ALARM RECURRED WHILE THE PATIENT WAS BENDING OVER WHILE CONNECTED TO MPU. ONE OF THE TIMES THE PATIENT ATTEMPTED TO REPLICATE THE ALARM, THE ALARM RECURRED WITHOUT ANY POSITIONAL CHANGE. UPON LOG FILE INTERROGATION BY THE HEALTHCARE PROVIDER (HCP), NO EXTERNAL POWER, LOW FLOW, AND LOW SPEED ALARMS WERE NOTED. THE HCP RAISED CONCERN FOR PATIENT SHORT-TO-SHIELD. THE PATIENT WAS ALSO NOTED TO HAVE A HISTORY OF COSMETIC DRIVELINE DAMAGE FOR WHICH RESCUE TAPE WAS APPLIED (CS-161372). IT WAS RECOMMENDED THAT THE PATIENT COME TO THE HOSPITAL FOR MONITORING, DRIVELINE X-RAYS, AND TO OBTAIN LOG FILES. THE PATIENT WAS TO REMAIN ON UN-GROUNDED CABLE SUPPORT. IT WAS REPORTED ON (B)(6) 2022 THAT LOG ANALYSIS CONFIRMED THAT THE PATIENT HAD A SHORT-TO-SHIELD AND IT WAS ADDITIONALLY REPORTED ON (B)(6) 2022 THAT THE PATIENT HAD AN EXTERNAL DRIVELINE REPAIR PERFORMED ON THAT DAY. IT WAS ADDITIONALLY REPORTED ON (B)(6) 2022 THAT THE ALARMS DID NOT RESOLVE WITH DRIVELINE REPAIR AND THUS THE PATIENT WAS PROVIDED WITH AN UNGROUNDED PATIENT CABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1301559 HEARTMATE II LVAS IMPLANT KIT (WITH SEALED GRAFTS) VENTRICULAR (ASSISST) BYPASS DSQ THORATEC CORPORATION 104911 00813024011170

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Male Required Intervention