BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL EASE PERICARDIAL BIOPROSTHESIS

    MDR report key: 1911229 · Received November 30, 2010

    Report

    Report Number
    2015691-2010-14450
    Event Type
    Injury
    Date Received
    November 30, 2010
    Date of Event
    November 2, 2010
    Report Date
    November 2, 2010
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S068
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6)=SIZING ISSUE. DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN. CONCLUSION: DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN. PER EMAIL RECEIVED ON 04-NOV-2010, THE PATIENT WAS TAKEN OFF BYPASS PRIOR TO EXPLANTING THE DEVICE. THERE IS NO INDICATION THAT AN ECHO WAS DONE. OPERATIVE REPORT HAS BEEN REQUESTED, BUT NOT RECEIVED. THE DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED, AND THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS WITH NO NONCONFORMANCES. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. INVESTIGATION IS ON-GOING.

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: NO INCONSISTENCIES DETECTED IN THE VALVE. THE LEAFLETS ARE INTACT AND FLEXIBLE. NO INCONSISTENCIES DETECTED IN THE X-RAY AS THE WIREFORM IS INTACT. THE WIREFORM WAS MEASURED TO BE 27.02MM AND THE EXTERNAL SEWING RING WAS MEASURED TO BE 38.03MM. CALIPER MET ID# (B)(4) WAS USED FOR THE MEASUREMENTS. THE EVENT WAS REPORTED AS A VALVE EXPLANT AT IMPLANT DUE TO A SIZING ISSUE. THIS IS TYPICALLY A RESULT OF INAPPROPRIATE SIZING, DISTORTION OF THE VALVE DURING IMPLANTATION AND/OR THE PATIENT'S ANATOMY, AND NOT A MALFUNCTION OF THE DEVICE. IN THIS CASE, THE SURGEON RECOGNIZED THAT A SMALLER DEVICE WOULD BENEFIT THE PATIENT REQUIRING REINSTITUTION OF BYPASS IN ORDER TO EXPLANT THE VALVE. THIS REQUIRED EXTENDED OPERATIVE AND CARDIOPULMONARY BYPASS TIME, WHICH INCREASED THE RISK OF THE PROCEDURE. HOWEVER, THIS WAS NOT AN ALLEGATION OF A DEVICE MALFUNCTION. X-RAY.

    Description of Event or Problem · 1

    IT WAS REPORTED TO OUR SALES REPRESENTATIVE THAT A DEVICE WAS EXPLANTED AT IMPLANT DUE TO A SIZING ISSUE. THE SURGEON FELT IT WAS "TOO LARGE AND IMPINGED ON THE VENTRICLE". A SMALLER SIZE OF THE SAME VALVE WAS USED AS A REPLACEMENT. THROUGH FOLLOW UP WITH THE SURGEON, IT WAS LEARNED THAT THE VENTRICLE HAD A SMALL TEAR, AND HE HAD TO REMOVE THE VALVE TO REPAIR THE TEAR. HE WAS NOT SURE WHAT CAUSED THE TEAR BUT FELT A SMALLER PROSTHESIS WAS WARRANTED, SO HE IMPLANTED A 25MM DEVICE.

    Description of Event or Problem · 1

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL EASE PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 7300TFX R-10G1971

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention