BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COREVALVE TRANSCATHETER AORTIC VALVE

    MDR report key: 7156411 · Received January 1, 2018

    Report

    Report Number
    2025587-2018-02590
    Event Type
    Injury
    Date Received
    January 1, 2018
    Date of Event
    May 13, 2015
    Report Date
    January 1, 2018
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: WEBER M. IMPACT OF LEFT VENTRICULAR CONDUCTION DEFECT WITH OR WITHOUT NEED FOR PERMANENT RIGHT VENTRICULAR PACING ON FUNCTIONAL AND CLINICAL RECOVERY AFTER TAVR. CLIN RES CARDIOL. 2015 NOV;104(11):964-74. DOI: 10.1007/S00392-015-0865-9. 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. 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 REGARDING THE IMPACT OF LEFT VENTRICULAR CONDUCTION DEFECT WITH OR WITHOUT NEED FOR PERMANENT RIGHT VENTRICULAR PACING AFTER TRANSCATHETER AORTIC VALVE REPLACEMENT. ALL DATA WERE COLLECTED FROM A SINGLE CENTER BETWEEN 2008 AND 2012. THE STUDY POPULATION INCLUDED 212 PATIENTS (PREDOMINANTLY MALE; MEAN AGE 81 YEARS), ALL OF WHICH WERE IMPLANTED WITH MEDTRONIC COREVALVE (SERIAL NUMBERS NOT PROVIDED). AMONG ALL PATIENTS 30-DAY, 3 AND 9 MONTH MORTALITY OCCURRED DUE TO UNSPECIFIED CAUSES. BASED ON THE AVAILABLE INFORMATION, NONE OF THE DEATHS WERE ATTRIBUTED TO MEDTRONIC PRODUCT. AMONG ALL PATIENTS ADVERSE EVENTS INCLUDED: LEFT BUNDLE BRANCH BLOCK (LBBB), SECOND AND THIRD DEGREE ATRIO-VENTRICULAR (AV) BLOCK REQUIRING A PERMANENT PACEMAKER, VENTRICULAR PERFORATION REQUIRING EMERGENT SURGERY, VALVE EMBOLIZATION INTO THE ASCENDING AORTA, SECOND VALVE IMPLANT DUE TO MALPOSITIONING, STROKE, MYOCARDIAL INFARCTION, AND VASCULAR COMPLICATIONS. BASED ON THE AVAILABLE INFORMATION, A DIRECT CORRELATION COULD 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
    36 COREVALVE TRANSCATHETER AORTIC VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT MEDTRONIC HEART VALVES DIVISION CRS

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention