BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE 3 LVAS IMPLANT KIT

    MDR report key: 14518439 · Received May 26, 2022

    Report

    Report Number
    2916596-2022-11019
    Event Type
    Death
    Date Received
    May 26, 2022
    Date of Event
    May 10, 2022
    Report Date
    May 26, 2022
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    PMA / PMN Number
    P160054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: A DIRECT CORRELATION BETWEEN HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS), SERIAL NUMBER (B)(4), AND THE REPORTED RIGHT HEART FAILURE, MESENTERIC ISCHEMIA, AND PATIENT OUTCOME COULD NOT BE CONCLUSIVELY ESTABLISHED THROUGH THIS EVALUATION. THE HOSPITAL REFUSED REQUESTS FOR ADDITIONAL INFORMATION REGARDING THE PATIENT OUTCOME DUE TO PATIENT PRIVACY LAWS. (B)(4) WAS NOT EXPLANTED FOR EVALUATION. THE PATIENT OUTCOME WAS NOT CONSIDERED TO BE DEVICE OR THERAPY RELATED. THE RELEVANT SECTIONS OF THE DEVICE HISTORY RECORDS FOR (B)(4) WERE REVIEWED AND SHOWED NO DEVIATIONS FROM MANUFACTURING OR QUALITY ASSURANCE SPECIFICATIONS. THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS) INSTRUCTIONS FOR USE (IFU), IS CURRENTLY AVAILABLE. SECTION 1 ¿INTRODUCTION¿ OF THIS DOCUMENT LISTS RIGHT HEART FAILURE AND DEATH AS ADVERSE EVENTS THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE 3 LVAS. ADDITIONALLY, SECTION 6 ¿PATIENT CARE AND MANAGEMENT¿ LISTS RIGHT HEART FAILURE AS A POTENTIAL RISK/ADVERSE EVENT THAT MAY BE ASSOCIATED WITH THE USE OF HEARTMATE 3 LVAS. THIS SECTION (UNDER ¿RIGHT HEART FAILURE¿) ALSO OUTLINES INDICATIONS OF RIGHT HEART FAILURE AS WELL AS POSSIBLE TREATMENTS. 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 PASSED AWAY ON (B)(6) 2022 DUE TO MESENTERIC ISCHEMIA. IT WAS ALSO NOTED THAT THE PATIENT DEVELOPED RIGHT HEART FAILURE POST IMPLANT AND THAT THE OUTCOME WAS NOT DEVICE OR THERAPY RELATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2605558 HEARTMATE 3 LVAS IMPLANT KIT VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106524INT 8255299

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Death