BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COREVALVE 31MM AORTIC VALVE

    MDR report key: 3935096 · Received July 15, 2014

    Report

    Report Number
    2025587-2014-00479
    Event Type
    Injury
    Date Received
    July 15, 2014
    Date of Event
    June 20, 2014
    Report Date
    August 4, 2014
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CLINICAL OBSERVATION DOES NOT INDICATE A POTENTIAL MANUFACTURING ISSUE, AND REVIEW OF THE DEVICE HISTORY RECORD 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 AND AORTIC REGURGITATION CAN BE CAUSED BY A VARIETY OF FACTORS, INCLUDING VALVE POSITIONING, PATIENT ANATOMY, OR PRESENCE OF PRE-EXISTING PATIENT CONDITIONS. IN THIS CASE, THE REPORT STATED THIS ISSUE WAS DUE TO POSITIONING AND INACCURATE DELIVERY, WHICH IS OFTEN INFLUENCED BY PATIENT ANATOMY AND USER TECHNIQUE, BUT A ROOT CAUSE OF THE LOW IMPLANT DEPTH COULD NOT BE DETERMINED FROM THE AVAILABLE INFORMATION.

    Additional Manufacturer Narrative · 1

    MODERATE CENTRAL AORTIC REGURGITATION (AR) WAS ALSO NOTED BEFORE THE SECOND VALVE WAS IMPLANTED.

    Additional Manufacturer Narrative · 1

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

    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).

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, THE VALVE WAS IMPLANTED AT A DEPTH OF 8 MILLIMETER (MM), RESULTING IN SEVERE PARAVALVULAR LEAK. A SECOND VALVE WAS IMPLANTED VALVE-IN-VALVE WITH GOOD HEMODYNAMIC RESULTS. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    412837 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 00067 YR Required Intervention