BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COREVALVE 29MM AORTIC VALVE

    MDR report key: 3802577 · Received May 9, 2014

    Report

    Report Number
    2025587-2014-00275
    Event Type
    Injury
    Date Received
    May 9, 2014
    Date of Event
    April 16, 2014
    Report Date
    June 3, 2014
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION CONCLUSION: A DEVICE HISTORY REVIEW IS NOT REQUIRED AS ONCE AGAIN, THE EVENT DESCRIPTION DOES NOT INDICATE A POTENTIAL MANUFACTURING ISSUE. PARAVALULAR LEAKAGE 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 AS THE VALVE WAS PLACE TOO LOW (14MM).

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    SEPARATE REPORTS HAVE BEEN FILED ON THE UNSUCCESSFUL PLACEMENTS OF THE FIRST AND SECOND VALVES. A SUPPLEMENTAL REPORT WILL BE FILED WHEN THE INVESTIGATION IS COMPLETED OR IF ADDITIONAL INFORMATION IS RECEIVED. (B)(4).

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THAT DURING IMPLANT, A TRANSCATHETER BIOPROSTHETIC VALVE WAS PLACED IN TOO LOW A POSITION, RESULTING IN CENTRAL REGURGITATION. A SNARE WAS USED ALONG WITH THE DELIVERY CATHETER SYSTEM (DCS) IN AN ATTEMPT TO BETTER POSITION THE VALVE; HOWEVER, IT MOVED ABOVE THE TARGET LOCATION AND WAS LEFT POSITIONED IN THE ASCENDING AORTA. A SUBSEQUENT ATTEMPT TO PLACE A SECOND VALVE OF THE SAME SIZE IN THE DESIRED LOCATION WAS UNSUCCESSFUL. THE IMPLANT OF THIS VALVE RESULTED IN ITS PLACEMENT IN A LOW POSITION. A FOURTH VALVE OF A SMALLER SIZE WAS THEN SUCCESSFULLY IMPLANTED VALVE-IN-VALVE INSIDE THIS VALVE. NO SUBSEQUENT ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281361 COREVALVE 29MM AORTIC VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT MEDTRONIC HEART VALVES DIVISION MCS-P3-29-AOA

    Patients

    Seq Age Sex Outcome Treatment
    1 00079 YR Required Intervention