BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COREVALVE 29MM AORTIC VALVE

    MDR report key: 4181074 · Received October 17, 2014

    Report

    Report Number
    2025587-2014-00769
    Event Type
    Injury
    Date Received
    October 17, 2014
    Date of Event
    September 22, 2014
    Report Date
    January 20, 2015
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT REMAINS IMPLANTED AND THEREFORE HAS NOT BEEN RETURNED TO MEDTRONIC. (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    CONCLUSION: 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. PARAVALVULAR LEAK CAN BE CAUSED BY A VARIETY OF FACTORS, INCLUDING VALVE POSITIONING, PATIENT ANATOMY, OR PRESENCE OF PRE-EXISTING PATIENT CONDITIONS. IN THIS CASE, IT WAS REPORTED THAT THE MODERATE PARAVALVULAR LEAK WAS DUE TO PATIENT ANATOMY (HEAVY CALCIFICATION IN THE NATIVE ANNULUS AND VALVE LEAFLETS). POST-IMPLANT DILATATION WITH A BALLOON DID NOT IMPROVE THE LEAK. A SECOND VALVE WAS IMPLANTED VALVE-IN-VALVE, RESULTING IN TRACE PARAVALVULAR LEAKAGE AS OBSERVED BY ECHOCARDIOGRAM. A TRACE/MILD PVL HAS MINIMAL IMPACT ON THE PATIENT AND IS GENERALLY DEEMED AN ACCEPTABLE RESIDUAL CONDITION.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THAT A MODERATE PARAVALVULAR LEAK WAS OBSERVED AFTER THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC HEART VALVE, DUE TO HEAVY CALCIFICATION IN THE NATIVE ANNULUS AND VALVE LEAFLETS. POST-IMPLANT DILATATION WITH A BALLOON DID NOT IMPROVE THE LEAK. A SECOND VALVE WAS IMPLANTED VALVE-IN-VALVE, RESULTING IN TRACE PARAVALVULAR LEAKAGE AS OBSERVED BY ECHOCARDIOGRAM. NO SUBSEQUENT ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    661683 COREVALVE 29MM AORTIC VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT MEDTRONIC HEART VALVES DIVISION MCS-P3-29-AOA

    Patients

    Seq Age Sex Outcome Treatment
    1 00076 YR Required Intervention MCS-P3-29-AOA, (B)(4)