BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COREVALVE 29MM AORTIC VALVE

    MDR report key: 5900303 · Received August 24, 2016

    Report

    Report Number
    2025587-2016-01315
    Event Type
    Injury
    Date Received
    August 24, 2016
    Date of Event
    March 1, 2010
    Report Date
    July 28, 2016
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: ZAHN R ET AL. SEVERE AORTIC REGURGITATION AFTER PERCUTANEOUS TRANSCATHETER AORTIC VALVE IMPLANTATION: ON THE IMPORTANCE TO CLARIFY THE UNDERLYING PATHOPHYSIOLOGY. CLIN RES CARDIOL (2010) 99:193¿197 DATE OF PUBLISH USED FOR EVENT DATE. NO UNIQUE DEVICE IDENTIFIER (SERIAL/LOT) NUMBERS WERE PROVIDED; WITHOUT THIS INFORMATION IT COULD NOT BE DETERMINED WHETHER THESE OBSERVATIONS HAVE BEEN PREVIOUSLY REPORTED. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION VIA LITERATURE OF A (B)(6) MALE PATIENT WITH RECURRENT HEART FAILURE DUE TO SEVERE AORTIC STENOSIS UNDERWENT TRANSCATHETER AORTIC VALVE IMPLANTATION (TAVI) WITH A MEDTRONIC 29-MM COREVALVE (SERIAL NUMBER NOT PROVIDED). IMMEDIATELY AFTER VALVE IMPLANTATION ANGIOGRAPHY DEMONSTRATED A MODERATE TO SEVERE AORTIC INSUFFICIENCY. UNDER THE ASSUMPTION OF A PARAVALVULAR LEAKAGE, A BALLOON VALVULOPLASTY WAS ATTEMPTED BUT A RUPTURE OF THE BALLOON OCCURRED WHICH MAY POSSIBLY HAVE DAMAGED THE VALVE LEAFLETS. IN THE FOLLOWING DAYS THE PATIENT HAD CONTINUED HEART FAILURE WITH SEVERE AORTIC INSUFFICIENCY. A TRANSESOPHAGEAL ECHOCARDIOGRAM REVEALED A SMALL PARAVALVULAR AND LARGE VALVULAR LEAKAGE, WHICH WAS SUSPECTED TO BE DUE TO POOR LEAFLET MOVEMENT/COAPTATION OF THE IMPLANTED VALVE. IN A SECOND TAVI PROCEDURE, A VALVE-IN-VALVE IMPLANTATION OF A NEW 29-MM COREVALVE WAS SUCCESSFULLY PERFORMED RESULTING IN SMALL PARAVALVULAR AORTIC INSUFFICIENCY. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    554004 COREVALVE 29MM AORTIC VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT MEDTRONIC HEART VALVES DIVISION MCS-P3-29-AOA-US

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR Required Intervention