BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENVEO R DELIVERY SYSTEM

    MDR report key: 5866365 · Received August 10, 2016

    Report

    Report Number
    2025587-2016-01217
    Event Type
    Injury
    Date Received
    August 10, 2016
    Date of Event
    July 5, 2016
    Report Date
    July 15, 2016
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: ASIL S. TRANSCATHETER AORTIC VALVE IMPLANTATION IN PATIENTS WITH A MITRAL PROSTHESIS; SINGLE CENTER EXPERIENCE AND REVIEW OF LITERATURE. INTERNATIONAL JOURNAL OF CARDIOLOGY. 2016; 221: 390¿395. 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

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

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION VIA LITERATURE REVIEW REGARDING TRANSCATHETER AORTIC VALVE IMPLANTATION (TAVI) IN PATIENTS WITH A MITRAL PROSTHESIS. ALL DATA WERE COLLECTED FROM A SINGLE CENTER BETWEEN FEBRUARY 2013 AND DECEMBER 2015. THE STUDY POPULATION INCLUDED 108 PATIENTS (PREDOMINANTLY FEMALE; MEAN AGE 76 YEARS), ALL OF WHICH WERE IMPLANTED WITH MEDTRONIC COREVALVE OR COREVALVE EVOLUT-R (SERIAL NUMBERS NOT PROVIDED). SIX OF THOSE 108 PATIENTS RECEIVED A TRANSCATHETER AORTIC VALVE AFTER HAVING A PREVIOUSLY IMPLANTED PROSTHETIC MITRAL VALVE (BRAND/MODEL/SERIALS NUMBERS NOT PROVIDED). PATIENT 6 (PLI 60 AND 70): A (B)(6) FEMALE PATIENT WITH A PREVIOUSLY IMPLANTED METALLIC BILEAFLET PROSTHETIC MITRAL VALVE UNDERWENT TRANSCATHETER AORTIC VALVE IMPLANTATION WITH A 29-MM COREVALVE EVOLUT-R. THE PATIENT WAS NOTED WITH MODERATE AORTIC REGURGITATION, AND A FEMORAL PSEUDOANEURYSM EXTRAVASATION VASCULAR COMPLICATION CLOSE TO THE EXTERNAL ILIAC ARTERY TREATED SURGICALLY TWO DAYS POST-TAVI. NO DYSFUNCTION OF THE MITRAL PROSTHESIS WAS NOTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    517514 ENVEO R DELIVERY SYSTEM AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT MEDTRONIC HEART VALVES DIVISION ENVEOR-L UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention