BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE 3 LVAS IMPLANT KIT

    MDR report key: 13347153 · Received January 25, 2022

    Report

    Report Number
    2916596-2022-00209
    Event Type
    Death
    Date Received
    January 25, 2022
    Date of Event
    January 5, 2022
    Report Date
    February 24, 2022
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013297
    PMA / PMN Number
    P160054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE
    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 COMPLETED.

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: 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 25OCT2021. THE HEARTMATE 3 LVAS IFU DOCUMENT IS CURRENTLY AVAILABLE. THIS IFU BLEEDING, RESPIRATORY FAILURE, AND DEATH AS ADVERSE EVENTS THAT MAY BE ASSOCIATED WITH THE USE OF HEARTMATE 3 LVAS. THE IFU ALSO LISTS MULTIPLE TYPES OF ORGAN FAILURE AND DYSFUNCTION (INCLUDING RIGHT HEART FAILURE, RESPIRATORY FAILURE, RENAL DYSFUNCTION, AND HEPATIC DYSFUNCTION) AS ADVERSE EVENTS THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE 3 LVAS. A DIRECT CORRELATION BETWEEN HEARTMATE 3 LVAS, SERIAL NUMBER (B)(6), AND THE REPORTED EVENTS COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS EVALUATION. THE HEARTMATE 3 LVAD, SERIAL NUMBER (B)(6), WAS NOT EXPLANTED. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT PRESENTED WITH HYPOXIC, HYPER CARBIC RESPIRATORY FAILURE AND CYTOMEGALOVIRUS (CMV) COLITIS ULTIMATELY REQUIRING RESECTION AND COLOSTOMY. RESPIRATORY FAILURE REQUIRING TRACHEOSTOMY, SUBSEQUENT RESPIRATORY FAILURE REQUIRING VV-ECMO, BACTEREMIA DUE TO ROTHIA AND ABIOTROPHIA, DAH (DIFFUSE ALVEOLAR HEMORRHAGE), AND PNEUMONIA FROM STENOTROPHOMONAS AND ACHROMOBACTER AS WELL AS POSSIBLY CMV PNEUMONIA. THE PATIENT PASSED AWAY DUE TO MULTIORGAN FAILURE WITH HEART FAILURE ON (B)(6) 2022. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1179879 HEARTMATE 3 LVAS IMPLANT KIT VENTRICULAR (ASSISST) BYPASS DSQ THORATEC CORPORATION 106524US 8173808 00813024013297

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Male Death