BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS MC3 TRICUSPID ANNULOPLASTY SYSTEM

    MDR report key: 1810284 · Received August 20, 2010

    Report

    Report Number
    2015691-2010-13929
    Event Type
    Injury
    Date Received
    August 20, 2010
    Date of Event
    June 8, 2010
    Report Date
    July 23, 2010
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    KRH
    PMA / PMN Number
    K020864
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): SIZING ISSUE.DEVICE NOT RETURNED. THE EVENT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY. THROUGH FOLLOW-UP WITH THE HEALTH-CARE PROVIDER (VIA FAX), ADDITIONAL INFORMATION AND A COPY OF THE OPERATIVE REPORT WAS RECEIVED. THE DEVICE HISTORY RECORD (DHR) REVIEW HAS BEEN COMPLETED AND THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS WITH NO NONCONFORMANCE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS EXPLANTED AFTER AN IMPLANT DURATION OF ZERO DAYS. ON (B)(6) 2010 (THROUGH FOLLOW-UP WITH THE HEALTH-CARE PROVIDER), IT WAS LEARNED THAT THE DEVICE WAS EXPLANTED DUE TO A SIZING ISSUE. PER THE OPERATIVE REPORT OF (B)(6) 2010, THE 36 MM ANNULOPLASTY RING WAS IMPLANTED. "THE TRANSESOPHAGEAL ECHOCARDIOGRAPHY REVEALED MORE THAN 2+ TRICUSPID REGURGITATION. BECAUSE OF THIS, THE CARDIOPULMONARY BYPASS WAS RE-INSTITUTED. THE AORTA WAS CROSSCLAMPED AND THE COLD BLOOD CARDIOPLEGIA WAS GIVEN ANTEGRADE TO ARREST THE HEART. THE VENA CAVA WAS SNARED AND THE RING ATRIUM WAS OPENED PARTIALLY. THE PREVIOUSLY PLACED RING WAS EXPLANTED. FRESH ROWS OF SUTURES WERE PLACED. THE AORTA WAS UNCLAMPED BECAUSE THERE WAS NO NEED TO ARREST THE HEART. THE 32 MM RING WAS CHOSEN AND SUTURES WERE PASSED THROUGH THE SEWING RING. THE RING WAS SEATED. SEATING WAS SATISFACTORY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EDWARDS MC3 TRICUSPID ANNULOPLASTY SYSTEM ANNULOPLASTY RING KRH EDWARDS LIFESCIENCES 4900 R-08K2346

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention