BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS IMPLANT KIT (WITH SEALED GRAFTS)

    MDR report key: 15880590 · Received November 29, 2022

    Report

    Report Number
    2916596-2022-14998
    Event Type
    Injury
    Date Received
    November 29, 2022
    Date of Event
    October 17, 2022
    Report Date
    November 29, 2022
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024011224
    PMA / PMN Number
    P060040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER¿S INVESTIGATION CONCLUSION: A DIRECT CORRELATION BETWEEN HEARTMATE (HM) II LEFT VENTRICULAR ASSIST SYSTEM (LVAS), SERIAL NUMBER (B)(4), AND THE REPORTED EVENTS COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS EVALUATION. IT WAS REPORTED THAT THE PATIENT UNDERWENT A LEFT HEART CATHETERIZATION (LHC) PROCEDURE ON (B)(6) 2022 THAT INVOLVED PLACEMENT OF A STENT IN THE SAPHENOUS VEIN GRAFT TO POSTERIOR DESCENDING ARTERY (SVG-PDA). IT WAS REPORTED THAT THE PATIENT UNDERWENT THE LHC PROCEDURE DUE TO VENTRICULAR TACHYCARDIA (VT) AND ISCHEMIC EVALUATION. THE PATIENT REMAINED ONGOING ON HMII LVAS, SERIAL NUMBER (B)(4), UNTIL ULTIMATELY EXPIRING ON (B)(6) 2022 (REFER TO MANUFACTURER REPORT NUMBER 2961956-2022-00001). THE RELEVANT SECTIONS OF THE DEVICE HISTORY RECORDS FOR (B)(4) WERE REVIEWED AND SHOWED NO DEVIATIONS FROM MANUFACTURING OR QUALITY ASSURANCE SPECIFICATIONS. THE IMPLANT KIT WAS SHIPPED ON 21MAR2016. THE HEARTMATE II LVAS IFU AND THE HEARTMATE II PATIENT HANDBOOK ARE CURRENTLY AVAILABLE. SECTION 1 OF THE IFU, ¿INTRODUCTION¿, LISTS POTENTIAL ADVERSE EVENTS THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 0

    THE PATIENT HAD A LEFT HEART CATHETERIZATION (LHC) WITH STENTING AND MEDICAL MANAGEMENT ON (B)(6) 2022. THE REASON FOR THE LHC/STENTING WAS DUE TO VENTRICULAR TACHYCARDIA (VT) AND ISCHEMIC EVALUATION. ONE STENT WAS PLACED TO SAPHENOUS VEIN GRAFT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1959511 HEARTMATE II LVAS IMPLANT KIT (WITH SEALED GRAFTS) VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106015 00813024011224

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Male Hospitalization| R