BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM

    MDR report key: 8421998 · Received March 14, 2019

    Report

    Report Number
    2916596-2019-01193
    Event Type
    Death
    Date Received
    March 14, 2019
    Date of Event
    February 7, 2019
    Report Date
    May 20, 2019
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013297
    PMA / PMN Number
    P160054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION B2: ADDITIONAL INFORMATION MANUFACTURER'S INVESTIGATION CONCLUSION: A DIRECT CORRELATION BETWEEN THE PATIENT¿S EXPIRATION AND MLP-011207 CANNOT BE CONCLUSIVELY DETERMINED. IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED WITH THE HEARTMATE 3 LVAS, SERIAL NUMBER (B)(4), ON (B)(6) 2019. ON (B)(6) 2019 THE PATIENT RETURNED TO THE OPERATING ROOM FOR AN EXPLORATORY LAP. AN ISCHEMIC BOWEL WAS FOUND DURING THE EVALUATION, BUT NO BOWEL RESECTION WAS PERFORMED. THE PATIENT LATER EXPIRED DUE TO CARDIOGENIC SHOCK. NO DEVICE RELATED ISSUES WERE REPORTED IN ASSOCIATION WITH THE EVENT AND THE HEARTMATE 3 LVAS, SERIAL NUMBER (B)(4), WAS NOT EXPLANTED FOR EVALUATION. THE HEARTMATE 3 LVAS INSTRUCTIONS FOR USE LISTS DEATH AS AN ADVERSE EVENT THAT MAY BE ASSOCIATED WITH THE USE OF HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 1

    APPROXIMATE AGE OF DEVICE: 9 DAYS. NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    THE PATIENT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD) ON (B)(6) 2019. IT WAS REPORTED THAT THE PATIENT RETURNED TO THE OPERATING ROOM ON (B)(6) 2019 FOR AN EXPLORATORY LAP WHICH FOUND AN ISCHEMIC BOWEL. HOWEVER, NO BOWEL RESECTION WAS PERFORMED. IT WAS LATER REPORTED THAT THE PATIENT EXPIRED DUE TO CARDIOGENIC SHOCK. THE DEVICE WAS NOT EXPLANTED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    213610 HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM LEFT VENTRICULAR ASSIST SYSTEM DSQ THORATEC CORPORATION 106524US 6592005 00813024013297

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Death