BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COSGROVE-EDWARDS TRICUSPID ANNULOPLASTY SYSTEM WITH DURAFLO TREATMENT

    MDR report key: 1707848 · Received June 2, 2010

    Report

    Report Number
    2015691-2010-13471
    Event Type
    Injury
    Date Received
    June 2, 2010
    Date of Event
    April 20, 2010
    Report Date
    May 3, 2010
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    KRH
    PMA / PMN Number
    K980487
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED. THIS EVENT WAS DETERMINED TO BE REPORTABLE PER EDWARDS LIFESCIENCES PROCEDURES. THE EVENT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY. THROUGH FOLLOW-UP WITH THE HEALTH-CARE PROVIDER (VIA FAX), ADDITIONAL INFORMATION AND THE OPERATIVE REPORT WAS RECEIVED ON 05/12/2010. THE DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED AND THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS WITH NO NONCONFORMANCE.

    Description of Event or Problem · 1

    IT WAS REPORTED IN AN ARTICLE IN NEUROSURGERY THAT THE PATIENT SUFFERED A PERI PROCEDURAL BASILAR ARTERY DISSECTION. THERE WAS NO REPORTED CLINICAL CONSEQUENCE TO THE PATIENT, THE PATIENT OUTCOME AFTER THE PROCEDURE WAS NOTED AS UNCHANGED COMPARED TO PRE PROCEDURE. NO OTHER INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS EXPLANTED AFTER AN IMPLANT DURATION OF APPROXIMATELY 73.1 MONTHS. ON 05/12/2010 (THROUGH FOLLOW-UP WITH THE HEALTH-CARE PROVIDER), IT WAS LEARNED THAT THE DEVICE WAS EXPLANTED DUE TO MITRAL REGURGITATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COSGROVE-EDWARDS TRICUSPID ANNULOPLASTY SYSTEM WITH DURAFLO TREATMENT ANNULOPLASTY RING KRH EDWARDS LIFESCIENCES 4625 3D0809

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Required Intervention