BEUDAMED
    FDA Adverse Event Death Summary report: N

    MELODY TRANSCATHER PULMONARY VALVE

    MDR report key: 4211650 · Received October 29, 2014

    Report

    Report Number
    2025587-2014-00817
    Event Type
    Death
    Date Received
    October 29, 2014
    Date of Event
    July 1, 2013
    Report Date
    November 11, 2014
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPV
    PMA / PMN Number
    H080002
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    WITH NO DEVICE- OR PATIENT-IDENTIFYING INFORMATION, MEDTRONIC¿S COMPLAINT DATABASE COULD NOT BE SEARCHED TO IDENTIFY ANY PREVIOUSLY REPORTED COMPLAINTS THAT MAY HAVE BEEN INCLUDED IN THIS ARTICLE. (B)(4).

    Additional Manufacturer Narrative · 1

    DEATH, OCCLUSION, VALVE DISLODGMENT AND RUPTURE ARE KNOWN POTENTIAL ADVERSE EVENTS FOR THIS DEVICE. AS THE DEVICES EITHER WERE NOT RETURNED FOR EVALUATION OR IDENTIFIED TO DETERMINE IF A DEVICE HAD PREVIOUSLY BEEN RETURNED FOR ANALYSIS, A FAILURE MECHANISM WAS NOT ABLE TO BE DETERMINED.

    Additional Manufacturer Narrative · 1

    NO EVAL EXPLAIN CODE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION VIA A LITERATURE REVIEW ARTICLE REGARDING THE USE OF NEW DEVICES IN CONGENITAL HEART DEFECT REPAIR SURGERY OF A PROCEDURAL MORTALITY RATE OF LESS THAN 0.2% ASSOCIATED WITH THE IMPLANT OF THIS FAMILY OF TRANSCATHETER PULMONARY VALVES. THE ARTICLE WAS BASED ON A REVIEW OF PUBLISHED LITERATURE AND DID NOT INCLUDE DETAILS REGARDING THE NUMBER OR DATES OF DEVICE IMPLANTS OR DEATHS, OR PATIENT DEMOGRAPHICS. THE ARTICLE INDICATED THAT THE MAIN COMPLICATION TO AVOID DURING THE IMPLANTATION IS CORONARY COMPRESSION OR OCCLUSION, WHICH CAN BE EVALUATED BY A PRE-IMPLANTATION BALLOON INFLATION IN THE RIGHT VENTRICULAR OUTFLOW TRACT (RVOT), AND THAT OTHER COMPLICATIONS OBSERVED DURING IMPLANT ARE THE DISLODGEMENT OF THE DEVICE WHEN IMPLANTED IN DISTENSIBLE AND DILATED RVOTS AND THE RISK OF HOMOGRAFT RUPTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    691688 MELODY TRANSCATHER PULMONARY VALVE PULMONARY VALVE PROSTHESIS PERCUTANEOUSLY DELIVERED NPV MEDTRONIC HEART VALVES DIVISION PB 10

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| H| R