BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOLUT R TRANSCATHETER AORTIC VALVE

    MDR report key: 6153221 · Received December 7, 2016

    Report

    Report Number
    2025587-2016-01956
    Event Type
    Injury
    Date Received
    December 7, 2016
    Date of Event
    October 1, 2016
    Report Date
    November 15, 2016
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: RASHID S ET AL. LOTUS-IN-EVOLUT R TRANSCATHETER AORTIC VALVE IMPLANTATION FOR SEVERE PARAVALVULAR LEAK. JOURNAL OF CARDIOLOGY CASES 14 (2016) 97¿99. HTTP://DX.DOI.ORG/10.1016/J.JCCASE.2016.05.003 EARLIEST 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.

    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 AN (B)(6) YEAR-OLD FEMALE PATIENT WITH SEVERE CALCIFIC AORTIC STENOSIS WHO UNDERWENT IMPLANT OF A 26-MM MEDTRONIC COREVALVE EVOLUTR (SERIAL NUMBER NOT PROVIDED). THE VALVE WAS DEPLOYED 5 MM BELOW THE CORONARY SINUS RESULTING IN SEVERE PARAVALVULAR LEAK (PVL). THE PATIENT WAS NOTED WITH SEVERE CALCIFICATION OF HER ANNULUS AND LEFT VENTRICULAR OUTFLOW TRACT THAT INITIALLY PREVENTED THE VALVE FROM GENERATING A SEAL WITH THE NATIVE ANNULUS. A BALLOON AORTIC VALVULOPLASTY WAS PERFORMED REDUCING THE PVL TO MODERATE WITH SATISFACTORY HEMODYNAMICS. TWENTY-FOUR HOURS POST-PROCEDURE, THE PATIENT EXPERIENCED PULMONARY EDEMA AND SUBSEQUENT CARDIOGENIC SHOCK. TRANSESOPHAGEAL ECHOCARDIOGRAM CONFIRMED MODERATE PVL THAT WAS POORLY TOLERATED. A NON-MEDTRONIC VALVE WAS IMPLANTED BELOW THE FRAME OF THE FIRST VALVE COMPLETELY RESOLVING THE PVL. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    803255 EVOLUT R TRANSCATHETER AORTIC VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT MEDTRONIC HEART VALVES DIVISION EVOLUTR-23

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Required Intervention