BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE II LVAS IMPLANT KIT (WITH SEALED GRAFTS)

    MDR report key: 12259321 · Received August 2, 2021

    Report

    Report Number
    2916596-2021-03895
    Event Type
    Death
    Date Received
    August 2, 2021
    Date of Event
    July 6, 2021
    Report Date
    October 25, 2021
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024011170
    PMA / PMN Number
    P060040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER INVESTIGATION CONCLUSION: THE REPORT OF POTENTIAL PUMP THROMBOSIS COULD NOT BE CONFIRMED THROUGH THIS EVALUATION. A DIRECT CORRELATION BETWEEN HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM (LVAS), SERIAL NUMBER (B)(6), AND THE PATIENT¿S OUTCOME COULD NOT CONCLUSIVELY BE ESTABLISHED THROUGH THIS EVALUATION. THE SUBMITTED LOG FILE CONTAINED APPROXIMATELY 12 HOURS OF DATA THAT PRIMARILY CONSISTED OF PULSATILITY INDEX (PI) EVENTS. NO HAZARD ALARMS WERE CAPTURED WITHIN THE FILE. THE PUMP SPEED REMAINED ABOVE THE LOW SPEED LIMIT AND THE LOG FILE DATA APPEARED TO SHOW THE PUMP OPERATING AS INTENDED. (B)(6) WAS NOT RETURNED FOR EVALUATION. 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 04FEB2013 VIA CUSTOMER ORDER (B)(4). THE HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM (LVAS) INSTRUCTIONS FOR USE (IFU), REV. C, IS CURRENTLY AVAILABLE. SECTION 1 OF THIS IFU LISTS DEVICE THROMBOSIS AND DEATH AS ADVERSE EVENTS THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM. PUMP SPEED, POWER, FLOW, AND PULSATILITY INDEX (PI) ARE ALSO ADDRESSED IN SECTION 1 OF THIS IFU. SECTION 4 EXPLAINS 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. THERE ARE NO AUDIBLE ALARMS WITH A PI EVENT. SECTION 6 EXPLAINS THAT PUMP PERFORMANCE IS SENSITIVE TO CHANGES IN SYSTEMIC VASCULAR RESISTANCE AND LEFT VENTRICULAR FILLING. THE PATIENT CARE AND MANAGEMENT SECTION OF THE IFU OUTLINES INDICATIONS OF THROMBUS AND HOW TO RESPOND TO SUCH EVENTS. SECTION 6 ALSO OUTLINES THE SUGGESTED ANTICOAGULATION REGIMEN AND INTERNATIONAL NORMALIZED RATIO (INR) RANGE THAT SHOULD BE MAINTAINED FOR PATIENTS USING THE HEARTMATE II LVAS AS WELL AS THE SUGGESTED ANTICOAGULATION MODIFICATIONS. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    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 POTENTIAL PUMP THROMBOSIS. IT WAS NOT CONFIRMED AS LABS DID NOT INDICATE THROMBOSIS. CHANGES TO PATIENT OR ANTICOAGULATION OR CHANGES TO PUMP PARAMETERS DID NOT CONTRIBUTE. THE LOG FILE CAPTURED PERSISTENT PULSATILITY INDEX (PI) EVENTS THROUGHOUT THE BRIEF LOG FILE, WHICH CAPTURED DATA OVER A 12 HOUR PERIOD. THE PUMP POWER WAS AT BASELINE THROUGHOUT. THE PI EVENTS CAUSED THE SPEED TO DROP TO ITS LOW SPEED LIMIT. THE TRANSIENT ELEVATION IN PUMP POWER MOST LIKELY TRIGGERED THE PI EVENT TO OCCUR. A COMPUTED TOMOGRAPHY WAS DONE AND THE PATIENT DECIDED TO TRANSITION TO PALLIATIVE CARE. THE PUMP WAS TURNED OFF AND CARE WAS WITHDRAWN. IT WAS REPORTED THAT THE PATIENT PASSED AWAY. DEVICE WOULD NOT BE RETURNED FOR EVALUATION, AN AUTOPSY WAS NOT PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1160630 HEARTMATE II LVAS IMPLANT KIT (WITH SEALED GRAFTS) VENTRICULAR (ASSISST) BYPASS DSQ THORATEC CORPORATION 104911 00813024011170

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Death| H