BEUDAMED
    FDA Adverse Event Other Summary report: N

    THORATEC

    MDR report key: 787097 · Received November 22, 2006

    Report

    Report Number
    MW1041135
    Event Type
    Other
    Date Received
    November 22, 2006
    Date of Event
    September 27, 2006
    Report Date
    November 22, 2006
    Manufacturer
    THORATEC CORP
    Product Code
    DSQ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IN, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PLACEMENT OF HEARTMATE XVE LVAD SCHEDULED FOR PT -BSA 2.1 ML AND BMI 29.6 KG/M2- THOUGH CONSIDERED "TIGHT FIT" DUE TO NARROW THORACIC SPACE. XVE DEVICE LABELED TO FIT < 1.5 M2 BSA. ON INTROPERATIVE MEASUREMENTS WITH STERILE SIZING DEVICE, DEMONSTRATED INABILITY TO IMPLANT DEVICE. PRIOR INTENT WAS TO SECURE INSURANCE -HEARTMATE II LVAS- WHICH IS 80% SMALLER THAN THE HM XVE. INSURANCE DID NOT APPROVE THE EXPERIMENTAL DEVICE, THUS PT WAS NOT INTENDED TO RECEIVE THE STUDY DEVICE. UNABLE TO IMPLANT THE HM XVE, THE SURGEON DID IMPLANT THE STUDY DEVICE, WHICH WAS PRESENT -IN EVENT INSURANCE WOULD GRANT APPROVAL- IN THE HEARTMATE II LVAS PIVOTAL STUDY: DESTINATION ARM. THE SPONSOR, THORATEC, HAD GRANTED PROTOCOL DEVIATION FOR INCLUSION IN THE SMALL PT COHORT, ALLOWING THE SMALLER DEVICE AND OMITTING RANDOMIZATION. INTRA-THORACIC MEASUREMENTS OF THIS PT WERE SUBMITTED TO SPONSOR; RIB TO RIB WIDTH 26.3CM X THORACIC INLET TO DIAPHRAM HEIGHT 24.6CM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THORATEC HEARTMATE XVE LVAD DSQ THORATEC CORP * *

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other