BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MELODY TRANSCATHER PULMONARY

    MDR report key: 2190316 · Received July 20, 2011

    Report

    Report Number
    2025587-2011-00088
    Event Type
    Injury
    Date Received
    July 20, 2011
    Date of Event
    January 21, 2009
    Report Date
    September 5, 2012
    Manufacturer
    MEDTRONIC HEART VALVES, INC.
    Product Code
    NPV
    PMA / PMN Number
    H080002
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SINCE THE INITIAL REPORT WAS SUBMITTED, ADDITIONAL INFORMATION WAS RECEIVED THAT APPROXIMATELY THREE AND ONE -HALF YEARS FOLLOWING IMPLANT, A VALVE IN VALVE PROCEDURE WAS PERFORMED DUE TO A TYPE II STENT FRACTURE AND STENOSIS. THE VALVE REMAINS IMPLANTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED. WITHOUT THE RETURN OF THE PRODUCT, NO DEFINITIVE CONCLUSION CAN BE MADE REGARDING THE CLINICAL OBSERVATION. (B)(4).

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFO THAT ONE YEAR POST IMPLANT OF THIS PULMONARY VALVED CONDUIT, A BALLOON ANGIOPLASTY WAS PERFORMED FOR STENOSIS. ACCORDING TO THE AVAILABLE INFO, THIS VALVE REMAINS IMPLANTED AND THERE WERE NO ADVERSE PT EFFECTS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention