BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MELODY TRANSCATHER PULMONARY

    MDR report key: 4140609 · Received October 3, 2014

    Report

    Report Number
    2025587-2014-00733
    Event Type
    Malfunction
    Date Received
    October 3, 2014
    Date of Event
    January 18, 2010
    Report Date
    September 10, 2014
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPV
    PMA / PMN Number
    H080002
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE REMAINS IMPLANTED. THE DEVICE HISTORY RECORD WAS REVIEWED AND SHOWED THAT THIS PRODUCT MET ALL MANUFACTURING SPECIFICATIONS FOR PRODUCT RELEASED FOR DISTRIBUTION. NO ISSUES WERE IDENTIFIED THAT WOULD HAVE IMPACTED THIS EVENT. BASED ON CLINICAL DATA AND LITERATURE, MELODY STENT FRACTURES ARE A KNOWN PHENOMENON. PROMINENT MECHANICAL STRESSES ON THE OUTFLOW TRACT STENT, SUCH AS COMPRESSION BETWEEN THE ANTERIOR CHEST WALL AND HEART, APPEAR TO BE ASSOCIATED WITH AN INCREASED RISK OF STENT FRACTURE. IN THIS CASE, THERE IS INSUFFICIENT INFORMATION TO DETERMINE A TRUE ROOT CAUSE TO THE REPORTED TYPE 1 STENT FRACTURES. (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 DURING FOLLOW-UPS BETWEEN SIX AND 61 MONTHS POST-IMPLANT, THIS TRANSCATHETER PULMONARY VALVE WAS FOUND TO HAVE SIX OR SEVEN POSSIBLE TYPE 1 STENT FRACTURES. THERE WAS NO LOSS OF DEVICE INTEGRITY. THERE WAS NO TREATMENT OR INTERVENTION REQUIRED, AND NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    620232 MELODY TRANSCATHER PULMONARY PULMONARY VALVE PROSTHESIS PERCUTANEOUSLY DELIVERED NPV MEDTRONIC HEART VALVES DIVISION PB10F18

    Patients

    Seq Age Sex Outcome Treatment
    1 00016 YR