BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COREVALVE 31MM AORTIC VALVE

    MDR report key: 3944178 · Received July 18, 2014

    Report

    Report Number
    2025587-2014-00490
    Event Type
    Injury
    Date Received
    July 18, 2014
    Date of Event
    June 24, 2014
    Report Date
    December 5, 2014
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Product Problem
    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. A SUPPLEMENTAL REPORT WILL BE FILED WHEN THE INVESTIGATION IS COMPLETED. (B)(4).

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORDS WERE REVIEWED AND SHOWED THAT THIS FINISHED DEVICE AND FRAME MET ALL MANUFACTURING SPECIFICATIONS FOR PRODUCT RELEASED FOR DISTRIBUTION. NO ISSUES WERE IDENTIFIED THAT WOULD HAVE IMPACTED THIS EVENT. THE DEVICE REMAINS IMPLANTED AND NO PROCEDURAL IMAGES WERE SUBMITTED FOR ANALYSIS. HISTORICALLY, FRAME UNDER-EXPANSION HAS OFTEN BEEN ATTRIBUTED TO PATIENT CONDITIONS SUCH AS COMPLEX ANATOMY AT THE DESIRED DEPLOYMENT LOCATION OR PRE-EXISTING CALCIFICATION WHICH PREVENTS THE FRAME FROM EXPANDING FULLY; HOWEVER, A ROOT CAUSE COULD NOT BE ESTABLISHED FROM THE INFORMATION AVAILABLE. PARAVALVULAR LEAK CAN BE CAUSED BY A VARIETY OF FACTORS, INCLUDING VALVE POSITIONING, PATIENT ANATOMY, OR PRESENCE OF PRE-EXISTING PATIENT CONDITIONS, AND A CONCLUSIVE CAUSE COULD NOT BE DETERMINED FROM THE INFORMATION AVAILABLE.

    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 THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, A POST-IMPLANT BALLOON AORTIC VALVULOPLASTY (BAV) WAS PERFORMED FOR MODERATE PARAVALVULAR LEAK (PVL), WHICH WAS UNRESOLVED BY THE BAV. IT WAS NOTED THAT THE VALVE DID NOT APPEAR TO OPPOSE THE INNER CURVATURE PORTION OF THE ANNULUS EVEN AFTER THE POST BAV. A SECOND VALVE WAS IMPLANTED SUCCESSFULLY INTO THE FIRST VALVE TO RESOLVE THE PVL. A SEPARATE MEDWATCH REPORT HAS BEEN FILED FOR A REPORT OF PROCEDURE-RELATED BLEEDING. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    422319 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 00083 YR Other