BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THORATEC® HEARTMATE®, LVAS IMPLANT KIT (WITH SEALED GRAFTS)

    MDR report key: 19795384 · Received July 22, 2024

    Report

    Report Number
    2916596-2024-04689
    Event Type
    Injury
    Date Received
    July 22, 2024
    Date of Event
    July 7, 2024
    Report Date
    October 22, 2024
    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
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION A: PATIENT INFORMATION WAS REQUESTED BUT NOT PROVIDED MANUFACTURER'S INVESTIGATION CONCLUSION: A DIRECT CORRELATION BETWEEN THE HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM (LVAS) AND THE REPORTED EVENT COULD NOT BE CONCLUSIVELY ESTABLISHED THROUGH THIS EVALUATION. A REVIEW OF THE SUBMITTED LOG FILE FOUND THAT THE PUMP APPEARED TO BE OPERATING AS INTENDED. MULTIPLE PULSATILITY INDEX (PI) EVENTS WERE CAPTURED ON (B)(6) 2024. THERE WERE NO NOTABLE ALARMS OR FINDINGS RELATED TO THE PUMP. MULTIPLE REQUESTS FOR ADDITIONAL INFORMATION REGARDING THIS EVENT WERE SUBMITTED TO THE ACCOUNT; HOWEVER, NO RESPONSE HAS BEEN RECEIVED AT THIS TIME. THE HEARTMATE II LVAS WAS NOT RETURNED FOR EVALUATION. THE SERIAL # OR OTHER IDENTIFYING INFORMATION OF THE DEVICE WAS NOT PROVIDED AND WAS NOT ABLE TO BE DETERMINED THROUGH THIS EVALUATION. THE HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM (LVAS) INSTRUCTIONS FOR USE (IFU) IS CURRENTLY AVAILABLE. SECTION 1 "INTRODUCTION" OF THIS DOCUMENT LISTS CARDIAC ARRHYTHMIA AS AN ADVERSE EVENT THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE II LVAS. SECTION 4 (UNDER ¿LOW SPEED LIMIT¿) OF THE IFU ADDRESSES PI EVENTS AS WELL AS POTENTIAL CAUSES. PI EVENTS ARE ASSUMED BY THE SYSTEM DURING CASES WHEN THERE ARE SUDDEN AND SUBSTANTIAL CHANGES IN THE PULSATILITY INDEX. THESE EVENTS ARE ALSO REFERRED TO AS PI EVENTS AND MAY BE INITIATED FOR REASONS OTHER THAN TRUE PI EVENTS. SOME REASONS INCLUDE SUDDEN CHANGES IN A PATIENT¿S VOLUME STATUS, ARRHYTHMIAS, SUDDEN CHANGES IN POWER, AND SUDDEN CHANGES IN PUMP SPEED. IF THE SYSTEM DETECTS A PI EVENT, THE PUMP SPEED AUTOMATICALLY DROPS TO THE LOW-SPEED LIMIT AND SLOWLY RAMPS BACK UP AT A RATE OF 100 RPM PER SECOND TO THE FIXED SPEED SETPOINT. THE CURRENT REVISIONS OF THE INSTRUCTIONS FOR USE (IFU) AND PATIENT HANDBOOK CAN ALSO BE FOUND ON THE ELECTRONIC IFU (EIFU) PAGE OF THE ABBOTT WEBSITE. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 0

    SECTION D4: DEVICE SERIAL NUMBER AND LOT NUMBER WERE NOT PROVIDED, AND EXPIRATION DATE AND MANUFACTURE DATE (H4) CANNOT BE DETERMINED. THE PRIMARY UDI NUMBER IN D4 IS REFLECTIVE OF ALL AVAILABLE INFORMATION. NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE MANUFACTURER¿S INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS SHOCKED BY THEIR DEFIBRILLATOR MULTIPLE TIMES. THE PATIENT STATED THAT THERE WAS A "BOLT OF LIGHT" COMING FROM THEIR CHEST AT THE TIME. THE LOG FILE CONTAINED CLUSTERS OF PULSATILITY INDEX (PI) EVENTS. THE REPORTED "BOLT OF LIGHT" WAS UNABLE TO BE CORRELATED WITH ANY DATA IN THE LOG FILE. NO OTHER UNUSUAL ALARMS OR EVENTS WERE SEEN IN THE LOG FILE. THE PUMP APPEARED TO BE OPERATING AS INTENDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2249798 THORATEC® HEARTMATE®, LVAS IMPLANT KIT (WITH SEALED GRAFTS) VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106015 00813024011224

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other