BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COREVALVE TRANSCATHETER AORTIC VALVE

    MDR report key: 6917017 · Received October 5, 2017

    Report

    Report Number
    2025587-2017-01766
    Event Type
    Injury
    Date Received
    October 5, 2017
    Date of Event
    June 17, 2014
    Report Date
    September 20, 2017
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: SARKAR, KUNAL MD. ET AL. CORE VALVE IMPLANT FAILURE IN THE PRESENCE OF MECHANICAL MITRAL PROSTHESIS: IMPORTANCE OF ASSESSING LEFT VENTRICULAR OUTFLOW TRACT. CATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS; (2015) 85:920¿924 DOI 10.1002/CCD.25376. EARLIEST DATE OF E-PUBLISH/PUBLISH USED FOR EVENT DATE.   NO UNIQUE DEVICE IDENTIFIER (SERIAL/LOT) NUMBERS WERE PROVIDED; WITHOUT THIS INFORMATION IT CANNOT BE DETERMINED WHETHER THIS EVENT HAS BEEN PREVIOUSLY REPORTED. 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 LITERATURE REGARDING A (B)(6)-YEAR-OLD FEMALE PATIENT WITH A PREVIOUSLY IMPLANTED NON MEDTRONIC MECHANICAL MITRAL VALVE. TEN YEARS AFTER THE IMPLANT OF THE MITRAL VALVE, A 31MM VALVE WAS IMPLANTED 8MM BELOW THE ANNULUS AND RESULTED IN MILD AORTIC REGURGITATION. THE PATIENT WAS DISCHARGED, BUT REMAINED ON HIGH DOSES OF DIURETICS AND COMPLAINED OF DYSPNEA A FOLLOW UP TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) INDICATED SEVERE CENTRAL REGURGITATION, FOCAL UNDER EXPANSION AND SUBSEQUENT POOR COAPTATION OF THE VALVE DUE TO INTERFERENCE OF THE MECHANICAL MITRAL VALVE. TWO BALLOON AORTIC VALVULOPLASTIES WERE PERFORMED AND RESOLVED THE REGURGITATION. IT WAS REPORTED THAT THE TRANSCATHETER VALVE WAS APPROPRIATELY SIZED AND IMPLANTED AT AN APPROPRIATE DEPTH. HOWEVER, THE MITRAL VALVE HAD BEEN SUTURED BELOW THE ANNULUS WHICH HAD ALTERED THE GEOMETRY OF THE LEFT VENTRICULAR OUTFLOW TRACT. NO ADDITIONAL ADVERSE PATIENT EFFECTS OR PRODUCT PERFORMANCE ISSUES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    697915 COREVALVE TRANSCATHETER AORTIC VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT MEDTRONIC HEART VALVES DIVISION MCS-P3-31-AOA-US

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention