BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COREVALVE 29MM AORTIC VALVE

    MDR report key: 4377945 · Received January 2, 2015

    Report

    Report Number
    2025587-2015-00019
    Event Type
    Injury
    Date Received
    January 2, 2015
    Date of Event
    December 8, 2014
    Report Date
    April 21, 2015
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT REMAINS IMPLANTED AND THEREFORE HAS NOT BEEN RETURNED TO MEDTRONIC. (B)(4)

    Additional Manufacturer Narrative · 1

    CONCLUSION: THE DEVICE HISTORY RECORD (DHR) FOR THIS VALVE WAS REVIEWED AND SHOWED THAT THIS DEVICE MET ALL MANUFACTURING SPECIFICATIONS FOR PRODUCT RELEASED FOR DISTRIBUTION. NO ISSUES WERE IDENTIFIED THAT WOULD HAVE IMPACTED THIS EVENT. A PARAVALVULAR LEAK CAN BE CAUSED BY A VARIETY OF FACTORS, INCLUDING VALVE POSITIONING, PATIENT ANATOMY, SIZING, OR PRESENCE OF PRE-EXISTING PATIENT CONDITIONS. THE OBSERVED PARAVALVULAR LEAK (PVL) WAS MOST LIKELY DUE TO SUBOPTIMAL POSITION CAUSED BY THE PATIENT ANATOMY, AS IT WAS REPORTED. INACCURATE DELIVERY/POSITIONING DIFFICULTY IS OFTEN INFLUENCED BY PATIENT ANATOMY AND USER TECHNIQUE. IN THIS CASE, MOST LIKELY WAS DUE TO PATIENT ANATOMY, AS CALCIFIED NATIVE LEAFLETS WERE REPORTED.

    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 DURING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE A 29MM VALVE WAS DEPLOYED INTO A 23MM ANNULUS. AT 2/3 DEPLOYMENT, THE VALVE WAS CORRECTLY POSITIONED AT 4MM ON THE NONCORONARY CUSP SIDE AND 1MM ON THE LEFT CORONARY CUSP SIDE IN WHICH VALVE WAS REPORTED TO NOT BE COMPLETELY SEATED AGAINST THE LEFT CORONARY CUSP. THE PHYSICIAN REPORTED THAT THE IMPROPER SEATING WAS DUE TO THE CALCIFICATION ON THE NATIVE LEAFLETS. THE VALVE WAS FULLY DEPLOYED AND WAS TOO HIGH AT NEGATIVE 2 MM ON NONCORONARY CUSP SIDE AND 0MM ON LEFT CORONARY CUSP SIDE. AN ANGIOGRAM REVEALED MODERATE TO SEVERE PARAVALVULAR LEAK (PVL). A POST BALLOON AORTIC VALVULOPLASTY (BAV) WAS COMPLETED WITH A 22MM BALLOON WITH NO REDUCTION IN THE SEVERITY OF LEAKAGE. A SECOND VALVE WAS IMPLANTED DEEPER INTO THE FIRST WITH SLIGHT IMPROVEMENT OF PVL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    820 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 00081 YR Required Intervention