BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COREVALVE TRANSCATHETER AORTIC VALVE

    MDR report key: 3952142 · Received July 23, 2014

    Report

    Report Number
    2025587-2014-00506
    Event Type
    Injury
    Date Received
    July 23, 2014
    Date of Event
    June 30, 2014
    Report Date
    March 4, 2019
    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 OR IF ADDITIONAL INFORMATION IS RECEIVED. (B)(4).

    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. PARAVALVULAR LEAK (PVL) 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 LIMITED INFORMATION AVAILABLE. IN THIS CASE, THE PVL WAS MOST LIKELY THE RESULT OF THE TOO LOW POSITIONING OF THE VALVE DURING IMPLANT, AS IT WAS REPORTED THAT THE VALVE WAS IMPLANTED TOO LOW. FROM THE INFORMATION PROVIDED, THE IMPLANT DEPTH OF THE VALVE IS UNKNOWN. PER THE INSTRUCTIONS FOR USE (IFU), THE BIOPROSTHESIS SHOULD BE PLACED SO THAT THE SKIRT IS WITHIN THE AORTIC ANNULUS. INACCURATE DELIVERY/POSITIONING DIFFICULTY IS OFTEN INFLUENCED BY PATIENT ANATOMY AND USER TECHNIQUE, BUT A ROOT CAUSE OF THE LOW IMPLANT DEPTH COULD NOT BE DETERMINED FROM THE LIMITED INFORMATION AVAILABLE.

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED WITH THE PATIENT'S WEIGHT AND WAS POPULATED. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT POSITIONING OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, THE VALVE MOVED TOO LOW A POSITION, RESULTING IN SEVERE PARAVALVULAR AORTIC REGURGITATION (AR). A SECOND VALVE WAS IMPLANTED SUCCESSFULLY, WITH MILD AR OBSERVED IMMEDIATELY POST-IMPLANT. THERE WAS NO SUBSEQUENT INTERVENTION, AND NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    431487 COREVALVE TRANSCATHETER AORTIC VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT MEDTRONIC HEART VALVES DIVISION MCS-P3-31-AOA

    Patients

    Seq Age Sex Outcome Treatment
    1 00073 YR Required Intervention