BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COREVALVE 23MM AORTIC VALVE

    MDR report key: 5866341 · Received August 10, 2016

    Report

    Report Number
    2025587-2016-01216
    Event Type
    Injury
    Date Received
    August 10, 2016
    Date of Event
    July 5, 2016
    Report Date
    November 21, 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. 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

    CORRECTION: CHANGE TO THE EVENT DESCRIPTION FROM "ATRIO-VENTRICULAR (AV) FISTULA" TO "ARTERIO-VENOUS FISTULA". THE PATIENT WAS NOTED WITH A FEMORAL ARTERIO-VENOUS FISTULA VASCULAR COMPLICATION THAT WAS TREATED WITH MANUAL COMPRESSION. 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

    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 1 (PLI 10): AN (B)(6) FEMALE PATIENT WITH A PREVIOUSLY IMPLANTED BIOPROSTHETIC MITRAL VALVE UNDERWENT TRANSCATHETER AORTIC VALVE IMPLANTATION WITH A 23-MM COREVALVE. THE PATIENT WAS NOTED WITH A FEMORAL ATRIO-VENTRICULAR FISTULA VASCULAR COMPLICATION THAT WAS TREATED WITH MANUAL COMPRESSION, AND COMPLETE HEART BLOCK WHICH REQUIRED PERMANENT PACEMAKER IMPLANT ONE MONTH 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
    517967 COREVALVE 23MM AORTIC VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT MEDTRONIC HEART VALVES DIVISION MCS-P4-23-AOA-US

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Required Intervention