BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE 3 LVAS IMPLANT KIT

    MDR report key: 15486957 · Received September 26, 2022

    Report

    Report Number
    2916596-2022-14063
    Event Type
    Injury
    Date Received
    September 26, 2022
    Date of Event
    December 18, 2020
    Report Date
    September 26, 2022
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013297
    PMA / PMN Number
    P160054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS EVENT WAS ORIGINALLY REPORTED UNDER MFR# 2916596-2022-01919 AS PART OF A HISTORICAL JMACS PATIENT REGISTRY REVIEW IN JAPAN THROUGH MCS ABBOTT JAPAN AFFILIATE. ON (B)(6) 2022 THE REVIEW OF FILES OF THIS EVENT TYPE WAS COMPLETED. MANUFACTURE¿S INVESTIGATION CONCLUSION: A DIRECT CORRELATION BETWEEN HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS), SERIAL NUMBER MLP-021602, AND THE REPORTED EVENT OF RESPIRATORY FAILURE COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS EVALUATION. THE PATIENT REMAINS ONGOING ON THE HEARTMATE 3 LEFT VENTRICULAR ASSISTANT DEVICE, SERIAL NUMBER (B)(4) NO PRODUCT IS AVAILABLE FOR INVESTIGATION. THE HEARTMATE 3 (HM3) LEFT VENTRICULAR ASSIST SYSTEM (LVAS) INSTRUCTIONS FOR USE (IFU) IS CURRENTLY AVAILABLE. SECTION 1 OF THE IFU, ¿INTRODUCTION¿, LISTS RESPIRATORY FAILURE AS AN ADVERSE EVENT THAT MAY BE ASSOCIATED WITH THE USE OF HEARTMATE 3 LVAS. THE RELEVANT SECTIONS OF THE DEVICE HISTORY RECORDS FOR (B)(4) WERE REVIEWED AND SHOWED NO DEVIATIONS FROM MANUFACTURING OR QUALITY ASSURANCE SPECIFICATIONS. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT SUFFERED FROM RESPIRATORY FAILURE 5 DAYS AFTER IMPLANT. THE PATIENT CONTINUED TRACHEAL INTUBATION. ALTHOUGH THE RELATIONSHIP BETWEEN RESPIRATORY FAILURE AND THE PUMP WAS LOW, IT COULD NOT BE DENIED AS THE PATIENT HAD TACHYPNEA DUE TO PAIN IN THE MID-CHEST WOUND ASSOCIATED WITH THE IMPLANTATION OF THE LVAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2928502 HEARTMATE 3 LVAS IMPLANT KIT VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106524US 7471119 00813024013297

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Male Required Intervention| L| H