BEUDAMED
    FDA Adverse Event Injury Summary report: N

    U-CLIP VALVE CLIP

    MDR report key: 2142339 · Received June 20, 2011

    Report

    Report Number
    2135394-2011-00007
    Event Type
    Injury
    Date Received
    June 20, 2011
    Date of Event
    May 11, 2011
    Report Date
    June 1, 2011
    Manufacturer
    MEDTRONIC PERFUSION SYSTEMS
    Product Code
    FZP
    PMA / PMN Number
    K031623
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION METHOD: OTHER - DEVICE HISTORY WAS NOT REVIEWED AS NO LOT NUMBER WAS PROVIDED. RESULTS: OTHER - NO PRODUCT WAS RETURNED. CONCLUSION: OTHER - CAUSE OF EVENT CANNOT BE DETERMINED. ANALYSIS: NO PRODUCT WAS RETURNED. CONCLUSION: WITHOUT FURTHER INFORMATION OR RETURNED PRODUCT, A DEFINITIVE CONCLUSION CANNOT BE DRAWN.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED THROUGH MEDTRONIC'S LEGAL DEPARTMENT THAT THIS ANNULOPLASTY BAND (NON-MEDTRONIC MANUFACTURER) AND U-CLIP FAILED (NO INFORMATION WAS PROVIDED ON THE FAILURE MECHANISM). IT WAS REPORTED THAT THE BAND WAS IMPLANTED (B)(6) 2009, BY USE OF A DAVINCI ROBOTIC MITRAL PROCEDURE AND FIXATED WITH U-CLIPS. IT WAS REPORTED THAT THE PATIENT HAD A COMPLICATION (NOT DEFINED) AND UNDERWENT SURGERY (B)(6) 2009, FOR REVISION OF THE BAND AND U-CLIP. THE PATIENT WAS REPORTED TO HAVE MULTIPLE ORGAN FAILURE AND "OTHER PROBLEMS." ADDITIONAL INFORMATION WAS NOT MADE AVAILABLE DUE TO LEGAL PROCESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 U-CLIP VALVE CLIP FZP MEDTRONIC PERFUSION SYSTEMS V100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention