BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS MC3 TRICUSPID ANNULOPLASTY RING

    MDR report key: 2499292 · Received March 21, 2012

    Report

    Report Number
    2015691-2012-17132
    Event Type
    Injury
    Date Received
    March 21, 2012
    Date of Event
    February 21, 2012
    Report Date
    February 22, 2012
    Manufacturer
    EDWARDS LIFESCIENCES LLC
    Product Code
    KRH
    PMA / PMN Number
    K020864
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: DEVICE RETURN ANTICIPATED, NOT YET RECEIVED. THE OPERATIVE REPORT RECEIVED CONFIRMED THE REPORT OF THE TRICUSPID RING DEHISCENCE AS WELL AS INDICATING THE PATIENT HAD A HISTORY OF TRICUSPID REGURGITATION. DEHISCENCE MAY OCCUR EARLY OR LATE, AND MAY BE DUE TO MULTIPLE FACTORS. THE DEVICE HISTORY RECORD REVIEW WAS COMPLETED AND CONFIRMS THAT THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS. THERE HAS BEEN NO INFORMATION TO SUGGEST A DEVICE QUALITY DEFICIENCY THAT MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A 4900 26MM TRICUSPID ANNULOPLASTY RING WAS EXPLANTED AFTER AN IMPLANT DURATION OF 22 MONTHS DUE TO DEHISCENCE. AS PER THE OPERATIVE NOTE, SEVERE TRICUSPID REGURGITATION WAS NOTED AS WELL AS RING DEHISCENCE AND RECURRENT SEVERE VALVULAR REGURGITANT LESIONS. "EXTREMELY DENSE PERICARDIAL ADHESIONS, DILATED MITRAL AND TRICUSPID ANNULUSES" WERE ALSO NOTED. THE RING WAS EXPLANTED AND A EDWARDS VALVE WAS SEATED WITHOUT ANY COMPLICATIONS. THE PATIENT ARRIVED AT THE ICU IN STABLE CONDITION. NO INFORMATION TO SUGGEST A DEVICE QUALITY DEFICIENCY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EDWARDS MC3 TRICUSPID ANNULOPLASTY RING ANNULOPLASTY RING KRH EDWARDS LIFESCIENCES LLC 4900 R-10B0380

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Hospitalization| O| S