BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARBOMEDICS STANDARD MITRAL MECHANICAL HEART VALVE (ORBIS)

    MDR report key: 4532632 · Received February 20, 2015

    Report

    Report Number
    3005687633-2015-00001
    Event Type
    Injury
    Date Received
    February 20, 2015
    Date of Event
    January 19, 2015
    Report Date
    February 20, 2015
    Manufacturer
    SORIN GROUP ITALIA S.R.L.
    Product Code
    LWQ
    PMA / PMN Number
    P900060/S018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY RECORDS REVIEW AND MECHANICAL EVALUATION OF THE DEVICE WILL BE CONDUCTED.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED EVEN AFTER SEVERAL REQUEST BY MEANS OF THE DISTRIBUTOR IN (B)(4). DEVICE NOT RETURNED.

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY RECORDS REVIEW AND MECHANICAL EVALUATION OF THE DEVICE WILL BE CONDUCTED. NOTE: THIS REPORT IS BEING RE-SUBMITTED TO INDICATE THE CORRECTION FOR PATIENT IDENTIFIER: IT SHOULD BE (B)(6), AND NOT (B)(6). G.5 - PMA/510 (K) SHOULD BE P900060/S018, AND NOT P0900060.

    Description of Event or Problem · 1

    THE COMPANY WAS NOTIFIED ON (B)(6) 2015 THAT AFTER IMPLANTING THE ORBIS VALVE (MODEL # M2-025, SERIAL # (B)(4)) THE DOCTOR OBSERVED THAT ONE OF THE LEAFLETS LAGGED OR DID NOT OPEN PROPERLY, EVEN AFTER ROTATING AND CHECKING THAT NO STRUCTURE WAS INTERFERING WITH THE LEAFLET MOTION. THE VALVE WAS REPLACED WITH ANOTHER DEVICE (TYPE, MODEL # AND SERIAL # WERE NOT PROVIDED).

    Description of Event or Problem · 1

    THE COMPANY WAS NOTIFIED ON (B)(6) 2015 THAT AFTER IMPLANTING THE ORBIS VALVE (MODEL # M2-025, SERIAL # (B)(4)) THE DOCTOR OBSERVED THAT ONE OF THE LEAFLETS LAGGED OR DID NOT OPEN PROPERLY, EVEN AFTER ROTATING AND CHECKING THAT NO STRUCTURE WAS INTERFERING WITH THE LEAFLET MOTION. IT WAS NOT REPORTED WHAT DEVICE WAS FINALLY IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123167 CARBOMEDICS STANDARD MITRAL MECHANICAL HEART VALVE (ORBIS) MECHANICAL HEART VALVE LWQ SORIN GROUP ITALIA S.R.L. CPHV

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Hospitalization| R