BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MELODY TRANSCATHER PULMONARY

    MDR report key: 2870268 · Received December 12, 2012

    Report

    Report Number
    2025587-2012-00192
    Event Type
    Malfunction
    Date Received
    December 12, 2012
    Date of Event
    September 4, 2012
    Report Date
    November 20, 2012
    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

    SUPPLEMENTAL REPORT SENT TO CORRECT EXPIRATION DATE.

    Additional Manufacturer Narrative · 1

    PRODUCT ANALYSIS/CONCLUSION: 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. THIS PRODUCT REMAINS IMPLANTED. WITHOUT THE RETURN OF THE PRODUCT, NO DEFINITIVE CONCLUSION CAN BE MADE REGARDING THE CLINICAL OBSERVATION. SHOULD ADDITIONAL INFORMATION BE PROVIDED, OR THE PRODUCT IS RETURNED, A FOLLOW-UP REPORT WILL BE SUBMITTED. (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 OVER FOUR YEARS POST IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, A CHEST RADIOGRAPH SHOWED A SINGLE WIRE FRACTURE ALONG THE ANTERIOR ASPECT OF THE STENT AT ITS MIDPORTION, IMMEDIATELY ADJACENT TO AN OVERLAP WELD. 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
    1 MELODY TRANSCATHER PULMONARY PULMONARY VALVE PROSTHESIS PERCUTANEOUSLY DELIVERED NPV HEART VALVES SANTA ANA PB10

    Patients

    Seq Age Sex Outcome Treatment
    1 00016 YR Other