BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE II LVAS IMPLANT KIT (WITH SEALED GRAFTS)

    MDR report key: 11971451 · Received June 9, 2021

    Report

    Report Number
    2916596-2021-03002
    Event Type
    Malfunction
    Date Received
    June 9, 2021
    Date of Event
    May 10, 2021
    Report Date
    October 20, 2021
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024011224
    PMA / PMN Number
    P060040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: ANALYSIS OF THE SUBMITTED LOG FILE CONFIRMED THE REPORTED DRIVELINE FAULT ALARM; HOWEVER, A SPECIFIC CAUSE FOR THIS EVENT COULD NOT CONCLUSIVELY BE DETERMINED. BASED ON PAST EXPERIENCE WITH THE HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM (LVAS) AND SIMILAR REPORTED EVENTS, THE LOG FILE FINDINGS COULD BE INDICATIVE OF A POTENTIAL DRIVELINE ISSUE. THE SUBMITTED LOG FILE CONTAINED DATA FROM (B)(6) 2021. IT WAS NOTED THAT THE MAJORITY OF THE FILE CONSISTED OF PULSATILITY INDEX (PI) EVENTS. ON (B)(6) 2021, A SINGLE DRIVELINE FAULT ALARM WAS OBSERVED THAT RESOLVED WITHIN THE NEXT EVENT. THERE WAS NO INTERRUPTION IN PUMP FUNCTION; THE PUMP OPERATED ABOVE THE LOW SPEED LIMIT FOR THE DURATION OF THE FILE. THE ACCOUNT LATER COMMUNICATED THAT THEY WERE ABLE TO IDENTIFY THE CAUSE OF THE DRIVELINE FAULT AND STATED THAT THE DEVICE OPERATED AS EXPECTED. THE PATIENT REMAINS ONGOING ON HEARTMATE II LVAS, SERIAL NUMBER (B)(6). THE HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM (LVAS) INSTRUCTIONS FOR USE (IFU), REV. C. IS CURRENTLY AVAILABLE. PUMP SPEED, POWER, FLOW, AND PULSATILITY INDEX (PI) ARE ALSO ADDRESSED IN SECTION 1 OF THIS IFU. THE IFU STATES THAT PI EVENTS MAY BE INITIATED FOR REASONS OTHER THAN TRUE SUCTION EVENTS. SOME REASONS INCLUDE SUDDEN CHANGES IN A PATIENT¿S VOLUME STATUS, ARRHYTHMIAS, SUDDEN CHANGES IN POWER AND SUDDEN CHANGES IN PUMP SPEED. SECTION 4 NOTES THAT PI EVENTS ARE ASSUMED BY THE SYSTEM DURING CASES WHEN THERE ARE SUDDEN AND SUBSTANTIAL CHANGES IN THE PULSATILITY INDEX. THIS DOCUMENT EXPLAINS THAT PUMP PERFORMANCE IS SENSITIVE TO CHANGES IN SYSTEMIC VASCULAR RESISTANCE AND LEFT VENTRICULAR FILLING. 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 HEARTMATE II LVAS PATIENT HANDBOOK, REV. C. 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. THE RELEVANT SECTIONS OF THE DEVICE HISTORY RECORDS FOR (B)(6) WERE REVIEWED AND SHOWED NO DEVIATIONS FROM MANUFACTURING OR QUALITY ASSURANCE SPECIFICATIONS. THE IMPLANT KIT WAS SHIPPED ON 07JAN2015. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    RELATED MANUFACTURER'S REPORT # 2916596-2021-05804.

    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¿S LOG FILE WAS SUBMITTED FOR REVIEW AS THE PATIENT WAS ON AN UNGROUNDED CABLE AND HAD A DRIVELINE FAULT ON THE MONITOR, BUT IT DIDN¿T ALARM AND CLEARED BY ITSELF. LOG FILE CAPTURED MAINLY PULSATILITY INDEX (PI) EVENTS AND DID NOTE A SINGLE DRIVELINE FAULT EVENT ON (B)(6) 2021 AT 12:12 THAT RESOLVED ON ITS OWN. MANUFACTURER REPRESENTATIVE CHECKED THE WIRE VALUES IN THE LOG FOR EACH OF THE SIX WIRES AND THEY APPEARED TO BE FUNCTIONING AS INTENDED. THE DRIVELINE FAULT APPEARED TO BE TRANSIENT AS IF IT WERE A TRUE DRIVELINE FAULT, THE EVENTS WOULD CONTINUE. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    867929 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