BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COREVALVE TRANSCATHETER AORTIC VALVE

    MDR report key: 7135680 · Received December 20, 2017

    Report

    Report Number
    2025587-2017-02518
    Event Type
    Injury
    Date Received
    December 20, 2017
    Date of Event
    July 15, 2014
    Report Date
    December 20, 2017
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: VARELA-LEMA L POST-INTRODUCTION OBSERVATION OF TRANSCATHETER AORTIC VALVE IMPLANTATION IN GALICIA (SPAIN). J EVAL CLIN PRACT. 2015 FEB;21(1):34-42. DOI: 10.1111/JEP.12225. 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. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION VIA LITERATURE REGARDING POST-INTRODUCTION OBSERVATION OF TRANSCATHETER AORTIC VALVE IMPLANTATION (TAVI). ALL DATA WERE COLLECTED FROM MULTIPLE CENTERS IN 2009. THE STUDY POPULATION INCLUDED 94 PATIENTS (PREDOMINANTLY FEMALE; MEAN AGE 82 YEARS), 33 OF WHICH WERE IMPLANTED WITH MEDTRONIC COREVALVE (SERIAL NUMBERS NOT PROVIDED). AMONG ALL PATIENTS SEVEN DEATHS OCCURRED FOLLOWING THE INTERVENTION DUE TO CARDIOVASCULAR CAUSES, SIX DEATHS OCCURRED WITHIN ONE YEAR DUE TO UNSPECIFIED CAUSES. BASED ON THE AVAILABLE INFORMATION, NONE OF THE DEATHS WERE ATTRIBUTED TO MEDTRONIC PRODUCT. AMONG ALL PATIENTS ADVERSE EVENTS INCLUDED: CONVERSION TO OPEN SURGERY, VALVE MIGRATION, POST-PROCEDURE MEAN GRADIENT OF 10 MMHG, MODERATE AORTIC REGURGITATION, ATRIAL FIBRILLATION (AFIB), VENTRICULAR ARRHYTHMIA, HEART BLOCK REQUIRING A PERMANENT PACEMAKER IMPLANT, STROKE, THROMBOSIS, MYOCARDIAL INFARCTION, ENDOCARDITIS, TAMPONADE, LEFT VENTRICLE RUPTURE, HEMORRHAGE, ILIAC/FEMORAL ARTERY LESIONS, AND VASCULAR ACCESS SITE COMPLICATIONS. MULTIPLE MANUFACTURERS WERE NOTED IN THE LITERATURE; BASED ON THE AVAILABLE INFORMATION A DIRECT CORRELATION COULD NOT BE MADE BETWEEN THE OBSERVED ADVERSE EVENTS AND MEDTRONIC PRODUCT. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    914503 COREVALVE TRANSCATHETER AORTIC VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT MEDTRONIC HEART VALVES DIVISION CRS

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Required Intervention