BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MELODY TRANSCATHER PULMONARY

    MDR report key: 3790684 · Received May 5, 2014

    Report

    Report Number
    2025587-2014-00264
    Event Type
    Injury
    Date Received
    May 5, 2014
    Date of Event
    April 9, 2014
    Report Date
    May 29, 2014
    Manufacturer
    MEDTRONIC HEART VALVES, INC.
    Product Code
    NPV
    PMA / PMN Number
    H080002
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT REMAINS IMPLANTED AND THEREFORE HAS NOT BEEN RETURNED TO MEDTRONIC. WITHOUT THE SERIAL NUMBER OF THE PRODUCT NO DEVICE HISTORY COULD BE PULLED AND REVIEWED. ADDITIONAL INFORMATION HAS BEEN REQUESTED. A SUPPLEMENTAL REPORT WILL BE FILED WHEN THE INVESTIGATION IS COMPLETED. (B)(4).

    Additional Manufacturer Narrative · 1

    WITHOUT THE SERIAL NUMBER A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED. A CONCLUSIVE ROOT CAUSE TO THIS VALVE¿S STENT FRACTURE WAS NOT DETERMINED. BASED ON CLINICAL DATA AND LITERATURE, STENT FRACTURES ARE A KNOWN PHENOMENON AND PROMINENT MECHANICAL STRESSES ON THE OUTFLOW TRACT STENT APPEAR TO BE ASSOCIATED WITH AN INCREASED RISK OF STENT FRACTURE.

    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 APPROXIMATELY SIX YEARS FOLLOWING THE IMPLANT OF THIS TRANSCATHETER PULMONARY VALVE (TPV), ANOTHER MANUFACTURER¿S VALVE WAS IMPLANTED WITHIN THIS DEVICE DUE TO STENOSIS AND CENTRAL REGURGITATION. THIS TPV INITIALLY WAS IMPLANTED WITHIN ANOTHER TPV DUE TO STENT FRACTURES. A STENTING OF THIS VALVE WAS PERFORMED; HOWEVER, THE RESULT OF THE STENTING WAS INCONCLUSIVE AND THE PHYSICIAN CONCLUDED THAT THE SCAFFOLDING OF THE STENOSED AREA WAS NOT STRONG ENOUGH TO SUPPORT A THIRD VALVE OF THIS TYPE. NO SUBSEQUENT ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    SUBSEQUENTLY, THE FACILITY THAT PERFORMED THE VALVE REPLACEMENT PROCEDURE INDICATED THAT THEY DID NOT HAVE THE SERIAL NUMBER OF THE PREVIOUS DEVICE IMPLANTS AS THEY WERE PERFORMED AT ANOTHER FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    268561 MELODY TRANSCATHER PULMONARY PULMONARY VALVE PROSTHESIS PERCUTANEOUSLY DELIVERED NPV MEDTRONIC HEART VALVES, INC. PB1018

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention