BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COREVALVE 31MM AORTIC VALVE

    MDR report key: 4132942 · Received October 1, 2014

    Report

    Report Number
    2025587-2014-00721
    Event Type
    Injury
    Date Received
    October 1, 2014
    Date of Event
    September 9, 2014
    Report Date
    January 2, 2015
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT REMAINS IMPLANTED AND THEREFORE HAS NOT BEEN RETURNED TO MEDTRONIC. A SUPPLEMENTAL REPORT WILL BE FILED WHEN THE INVESTIGATION IS COMPLETED. (B)(4).

    Additional Manufacturer Narrative · 1

    THE REPORTED INFORMATION DID NOT INDICATE A POTENTIAL MANUFACTURING ISSUE. PARAVALVULAR LEAK (PVL) CAN BE CAUSED BY A VARIETY OF FACTORS, INCLUDING VALVE POSITIONING, PATIENT ANATOMY, OR THE PRESENCE OF PRE-EXISTING PATIENT CONDITIONS. IN THIS CASE, IT WAS REPORTED THAT CALCIFIED ANNULUS (PATIENT ANATOMY) WOULD NOT ALLOW FULL EXPANSION OF THE VALVE LEAFLETS. THE ISSUE WAS SUCCESSFULLY RESOLVED THROUGH IMPLANT OF A SECOND VALVE, VALVE-IN-VALVE AT THE SAME DEPTH, WHICH IMPROVED THE PVL FROM SEVERE TO MILD. A MILD PVL HAS MINIMAL IMPACT ON THE PATIENT AND IS GENERALLY DEEMED AN ACCEPTABLE RESIDUAL CONDITION.

    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 FOLLOWING DEPLOYMENT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE THE PATIENT¿S CALCIFIED ANNULUS WOULD NOT ALLOW FULL EXPANSION OF THE VALVE LEAFLETS, RESULTING IN SEVERE PARAVALVULAR LEAK (PVL). A SECOND TRANSCATHETER BIOPROSTHETIC VALVE WAS SUCCESSFULLY IMPLANTED VALVE-IN-VALVE, WHICH IMPROVED THE PVL FROM SEVERE TO MILD. THERE WAS NO FURTHER TREATMENT OR INTERVENTION. NO SUBSEQUENT ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    612351 COREVALVE 31MM AORTIC VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT MEDTRONIC HEART VALVES DIVISION MCS-P3-31-AOA

    Patients

    Seq Age Sex Outcome Treatment
    1 00091 YR Required Intervention