BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COREVALVE 29MM AORTIC VALVE

    MDR report key: 3926409 · Received July 10, 2014

    Report

    Report Number
    2025587-2014-00455
    Event Type
    Injury
    Date Received
    July 10, 2014
    Date of Event
    June 13, 2014
    Report Date
    August 1, 2014
    Manufacturer
    HEART VALVES SANTA ANA
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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.

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THE REPORTED INFORMATION DOES 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 THE MODERATE TO SEVERE PVL WAS A RESULT OF THE VALVE WAS PLACED HIGH. INACCURATE DELIVERY IS OFTEN INFLUENCED BY PATIENT ANATOMY AND USER TECHNIQUE, BUT A ROOT CAUSE OF THE HIGH IMPLANT DEPTH COULD NOT BE DETERMINED FROM THE AVAILABLE INFORMATION. A SECOND VALVE WAS IMPLANTED AT A LOWER DEPTH, IMPROVING THE PARAVALVULAR LEAK TO MILD. A MILD PVL HAS MINIMAL IMPACT ON THE PATIENT AND IS GENERALLY DEEMED AN ACCEPTABLE RESIDUAL CONDITION.

    Additional Manufacturer Narrative · 1

    PRODUCT ANALYSIS: THE DEVICE REMAINS IMPLANTED, THEREFORE NO PRODUCT ANALYSIS CAN BE PERFORMED. (B)(4).

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, THE VALVE WAS PLACED HIGH WHICH RESULTED IN MODERATE TO SEVERE PARAVALVULAR LEAK (PVL). A SECOND VALVE WAS IMPLANTED INTO THE FIRST VALVE AT A LOWER DEPTH, REDUCING THE PVL TO MILD. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    404621 COREVALVE 29MM AORTIC VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT HEART VALVES SANTA ANA MCS-P3-29-AOA

    Patients

    Seq Age Sex Outcome Treatment
    1 00063 YR Required Intervention