BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MELODY TRANSCATHER PULMONARY

    MDR report key: 2930284 · Received January 25, 2013

    Report

    Report Number
    2025587-2013-00009
    Event Type
    Malfunction
    Date Received
    January 25, 2013
    Date of Event
    December 18, 2012
    Report Date
    January 2, 2013
    Manufacturer
    HEART VALVES SANTA ANA
    Product Code
    NPV
    PMA / PMN Number
    H080002
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ANALYSIS: THE VALVE REMAINS IMPLANTED AND THEREFORE, HAS NOT BEEN RETURNED TO MEDTRONIC. CONCLUSION: WITHOUT THE RETURN OF THE PRODUCT, NO DEFINITIVE CONCLUSION CAN BE MADE 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. (B)(6). (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THAT FOUR YEARS POST IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, TWO SMALL TYPE I STENT FRACTURES WERE NOTED (ONE AT PROXIMAL ROW OF ZIGS <(>&<)> ONE AT DISTAL ROW OF ZIGS). IT WAS REPORTED THAT NO INTERVENTION HAS BEEN REQUIRED AND THE VALVE REMAINED IMPLANTED WITH NO ADVERSE PATIENT EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    35994 MELODY TRANSCATHER PULMONARY PULMONARY VALVE PROSTHESIS PERCUTANEOUSLY DELIVERED NPV HEART VALVES SANTA ANA PB10

    Patients

    Seq Age Sex Outcome Treatment
    1 00013 YR