BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS® PHYSIO II ANNULOPLASTY RING

    MDR report key: 2171640 · Received July 21, 2011

    Report

    Report Number
    2015691-2011-15896
    Event Type
    Injury
    Date Received
    July 21, 2011
    Date of Event
    June 24, 2011
    Report Date
    June 28, 2011
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    KRH
    PMA / PMN Number
    K083470
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: AS RECEIVED THE RING EXHIBITS MODERATE HOST TISSUE OVERGROWTH. CUTS IN THE SEWING FABRIC ARE EVIDENT WHICH EXPOSED APPROXIMATELY 1CM OF THE RING; THE CUTS ARE MOST LIKELY DUE TO MECHANICAL DAMAGE AT EXPLANT. NO INCONSISTENCIES DETECTED IN THE X-RAY, AS THE RING IS INTACT. X-RAY. ADDITIONAL MANUFACTURER NARRATIVE: THE DEVICE HISTORY RECORD REVIEW WAS COMPLETED AND CONFIRMS THAT THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS AND FOUND NO NON CONFORMANCES RELATED TO THE EVENT. OVERALL, THE INVESTIGATION RESULTS DID NOT INDICATE A PRODUCT QUALITY DEFICIENCY DURING THE MANUFACTURE OF THE DEVICE THAT MAY HAVE CONTRIBUTED TO THIS EVENT. THE DEVICE REMAINED IMPLANTED FOR APPROXIMATELY 1 YEAR. THE SURGEON REPLACED THE RING AND PATIENT'S NATIVE VALVE WITH A PROSTHETIC VALVE. IT APPEARS THAT PATIENT FACTORS SUCH AS IMMUNE STATUS AND/OR DISEASE STATE CONTRIBUTED TO THE EVENT.

    Additional Manufacturer Narrative · 1

    EVALUATION: METHOD (B)(4) - OTHER- DEVICE EVALUATION ANTICIPATED, NOT YET BEGUN. CONCLUSION (B)(4) - OTHER - DEVICE EVALUATION ANTICIPATED, NOT YET BEGUN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SURGEON EXPLANTED AN EDWARDS 34MM MITRAL RING DUE TO MITRAL REGURGITATION AFTER APPROXIMATELY 1 YEAR IMPLANT DURATION. SURGEON REPLACED WITH A MITRAL MAGNA VALVE. PER THE OPERATIVE REPORT, AFTER SURGERY, THE PATIENT WAS TRANSFERRED TO THE ICU IN SATISFACTORY CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARPENTIER-EDWARDS® PHYSIO II ANNULOPLASTY RING ANNULOPLASTY RING KRH EDWARDS LIFESCIENCES 5200 R-09J2022

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization| R