BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE 3 LVAS IMPLANT KIT

    MDR report key: 10546935 · Received September 17, 2020

    Report

    Report Number
    2916596-2020-04452
    Event Type
    Death
    Date Received
    September 17, 2020
    Date of Event
    February 28, 2020
    Report Date
    March 26, 2021
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    PMA / PMN Number
    P160054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: A DIRECT CORRELATION BETWEEN HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM, SERIAL NUMBER (B)(6), AND THE PATIENT EXPIRATION CANNOT BE CONCLUSIVELY DETERMINED THROUGH THIS INVESTIGATION. THE ACCOUNT COMMUNICATED THAT HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM, SERIAL NUMBER (B)(6), WAS NOT EXPLANTED AND WOULD NOT BE RETURNED FOR EVALUATION. NO FURTHER INFORMATION REGARDING THE EVENT HAS BEEN PROVIDED AT THIS TIME. THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM INSTRUCTIONS FOR USE CONTAINS THE FOLLOWING INFORMATION: SECTION 1 LISTS BLEEDING, STROKE, AND DEATH AS ADVERSE EVENTS THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM. SECTION 6 PROVIDES INFORMATION REGARDING INTERNATIONAL NORMALIZED RATIO RANGE. THE RELEVANT SECTIONS OF THE DEVICE HISTORY RECORDS WERE REVIEWED AND SHOWED NO DEVIATION FROM MANUFACTURING OR QUALITY ASSURANCE SPECIFICATIONS. THE IMPLANT KIT SHIPPED ON (B)(6) 2016. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 1

    (B)(6). 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 ON (B)(6) 2020 THE PATIENT'S INR WAS 5.98. ON (B)(6) 2020, THE PATIENT HAD A CESSATION OF BREATHING AND CARDIOVASCULAR ACTIVITY AT 23:50. THE MONITOR SHOWED BLOOD PRESSURE AT 0 AND PULSE AT 0. THE PATIENT'S PUPILS WERE DILATED AND THERE WAS NO REACTION. RESUSCITATION MEASURES WERE STARTED AND THE PATIENT HAD A VENTILATOR. HEALTHCARE PROVIDERS ADMINISTERED INDIRECT HEART MASSAGE AND RESUSCITATION MEASURES WITHIN 30 MINUTES WERE NOT EFFECTIVE. CARDIAC ACTIVITY HAD NOT BEEN RECOVERED AND CARDIAC ACTIVITY THROUGH AUSCULTATION WAS NOT HEART. THERE WAS NO PULSATION ON THE CAROTID ARTERY OR ON THE PERIPHERY. 'MARBLING' OF THE SKIN APPEARED IN SOME PLACES. THE PUPILS WERE STILL DILATED AND THERE WAS AGAIN NO REACTION. THE PATIENT'S DEATH WAS DECLARED AT 00:30 ON (B)(6) 2020. THERE WAS NO ALARM FOR THE EVENT. CAUSE OF DEATH WAS REPORTED AS STROKE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1014678 HEARTMATE 3 LVAS IMPLANT KIT VENTRICULAR (ASSISST) BYPASS DSQ THORATEC CORPORATION 106524INT 5502819

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Death