BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COREVALVE 31MM AORTIC VALVE

    MDR report key: 3760234 · Received April 18, 2014

    Report

    Report Number
    2025587-2014-00226
    Event Type
    Injury
    Date Received
    April 18, 2014
    Date of Event
    March 26, 2014
    Report Date
    May 5, 2014
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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. PARAVALVULAR LEAK CAN BE CAUSED BY A VARIETY OF FACTORS, INCLUDING VALVE POSITIONING, PATIENT ANATOMY, OR THE PRESENCE OF PRE-EXISTING PATIENT CONDITIONS. IT APPEARS THAT THE PARAVALVULAR LEAK ASSOCIATED WITH THIS VALVE WAS DUE TO LOW POSITIONING; HOWEVER, WITHOUT RETURN OF THE PRODUCTS INVOLVED IN THE CLINICAL OBSERVATION, A CONCLUSIVE CAUSE COULD NOT BE DETERMINED FROM THE INFORMATION AVAILABLE.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT SEVERE PARAVALVULAR LEAK (PVL) WAS NOTED AFTER DISLODGEMENT OF THE FIRST TWO VALVES. THE THIRD VALVE HAD BEEN POSITIONED LOW IN THE LEFT VENTRICULAR OUTFLOW TRACT (LVOT).

    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. ADDITIONAL INFORMATION HAS BEEN REQUESTED. A SUPPLEMENTAL REPORT WILL BE FILED IF ADDITIONAL INFORMATION IS RECEIVED OR WHEN THE INVESTIGATION IS COMPLETED. (B)(4).

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THAT THIS WAS THE THIRD OF THREE TRANSCATHETER BIOPROSTHETIC VALVES THAT WERE NOT SUCCESSFULLY IMPLANTED. IT WAS REPORTED THAT THE FIRST VALVE DISLODGED OUT OF THE ANNULAR POSITION DURING THE REMOVAL OF THE DELIVERY CATHETER SYSTEM (DCS), POSSIBLY AFTER THE DCS NOSE CONE BECAME CAUGHT ON THE BOTTOM OF THE VALVE. THE SECOND VALVE DISLODGED FROM THE ANNULUS AFTER RELEASE FROM THE DCS; THERE WAS NO OBSERVED OR SUSPECTED REASON FOR THE DISLODGEMENT REPORTED. THIS VALVE WAS PLACED IN TOO DEEP A POSITION, RESULTING IN SEVERE PARAVALVULAR AORTIC REGURGITATION. AN ATTEMPT TO REPOSITION THE VALVE WITH A SNARE WAS UNSUCCESSFUL. IT WAS REPORTED THAT THE PATIENT BECAME HYPOTENSIVE, SO ANOTHER MANUFACTURER'S TRANSCATHETER BIOPROSTHETIC HEART VALVE WAS IMPLANTED WITHIN THIS VALVE. THE FIRST TWO VALVES ALSO WERE NOT EXPLANTED. NO SUBSEQUENT ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236884 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 Required Intervention