BEUDAMED
    FDA Adverse Event Death Summary report: N

    CPHV OPTIFORM

    MDR report key: 445251 · Received February 28, 2003

    Report

    Report Number
    1627803-2003-00002
    Event Type
    Death
    Date Received
    February 28, 2003
    Date of Event
    January 28, 2003
    Report Date
    February 28, 2003
    Manufacturer
    CARBOMEDICS INC.
    Product Code
    LWQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A CARBOMEDICS INC. FIELD REPRESENTATIVE LEARNED OF A PATIENT DEATH FROM A STAFF MEMBER. THE HOSPITAL WAS CONTACTED TO TRY TO OBTAIN INFORMATION REGARDING THE EVENT. THE HOSPTIAL GAVE THE FOLLOWING BRIEF SUMMARY TO THE MANUFACTURER: A PATIENT WAS IMPLANTED WITH A SIZE 33 CPHV OPTIFORM VALVE IN 2002. POST-OP RECOVERY WAS UNEVENTFUL AND THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. ON THE EVENT DATE, THE PATIENT SUDDENLY DEVELOPED SHORTNESS OF BREATH AND OTHER SIGNS OF HEART FAILURE. AN ECHO WAS PERFORMED AND THE VALVE WAS OBSERVED TO HAVE REGURGITATION. THE PATIENT WAS IMMEDIATELY RE-OPERATED ON. A STABLE BY-PASS CONDITION WAS REACHED. UPON OPENING THE HEART, THE CPHV OPTIFORM VALVE WAS OBSERVED TO HAVE ONE LEAFLET MISSING. THE VALVE WAS REMOVED AND REPLACED WITH A VALVE OF ANOTHER TYPE. THE SURGEON BRIEFLY EXPLORED THE VENTRICLE AND ATRIUM FOR THE MISSING LEAFLET BUT IT WAS NOT FOUND. THE PATIENT REPORTEDLY DIED ONE OR TWO DAYS LATER. THE CORONER REPORTED THE LEAFLET WAS LATER FOUND BROKEN INTO TWO PARTS. ONE PART WAS FOUND IN THE BIFURCATION AREA AND THE OTHER IN THE ILIAC ARTERY. THE CORONER STATED THE LEAFLET WAS BROKEN IN HALF. THE HOSPITAL WOULD RELEASE NO MORE INFORMATION TO THE MANUFACUTER AND THE MANUFACTUER HAS NOT BEEN ABLE TO VIEW THE VALVE OR LEAFLET PARTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CPHV OPTIFORM PROSTHETIC HEART VALVE, MECHANICAL LWQ CARBOMEDICS INC. F700 A524532-B

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Death