BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MELODY TRANSATHER PULMONARY VALVE

    MDR report key: 2233299 · Received July 22, 2011

    Report

    Report Number
    2025587-2011-00094
    Event Type
    Malfunction
    Date Received
    July 22, 2011
    Date of Event
    June 24, 2011
    Report Date
    June 24, 2011
    Manufacturer
    MEDTRONIC HEART VALVES, INC.
    Product Code
    NPV
    PMA / PMN Number
    H080002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE HISTORY REVIEWED. DEVICE HISTORY REVIEW FOUND THE PRODUCT MET SPECIFICATIONS WHEN RELEASED FOR DISTRIBUTION. CAUSE OF EVENT CANNOT BE DETERMINED. ANALYSIS: NO PRODUCT WAS RETURNED. CONCLUSION: THE DEVICE HISTORY RECORD WAS REVIEWED AND SHOWED THAT THIS VALVE MET ALL MANUFACTURING SPECIFICATIONS FOR PRODUCT RELEASED FOR DISTRIBUTION. NO ISSUES WERE IDENTIFIED THAT WOULD HAVE IMPACTED THIS EVENT. WITHOUT THE RETURN OF THE PRODUCT, NO DEFINITIVE CONCLUSION CAN BE MADE REGARDING THE CLINICAL OBSERVATION.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THAT THIS TRANSCATHETER BIOPROSTHETIC VALVE EXHIBITED MINOR STENT FRACTURE AS OBSERVED ON FLUOROSCOPY AT 6 MONTH FOLLOW UP. NO INTERVENTION HAS BEEN PERFORMED. NO ADVERSE PT EFFECTS HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MELODY TRANSATHER PULMONARY VALVE NPV MEDTRONIC HEART VALVES, INC. PB 10 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Life Threatening