BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOLUT R TRANSCATHETER AORTIC VALVE

    MDR report key: 6794198 · Received August 15, 2017

    Report

    Report Number
    2025587-2017-01390
    Event Type
    Injury
    Date Received
    August 15, 2017
    Date of Event
    March 17, 2017
    Report Date
    July 21, 2017
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: V. NIJENHUIS ET AL. SEVERE CONDUCTION DEFECTS REQUIRING PERMANENT PACEMAKER IMPLANTATION IN PATIENTS WITH A NEW-ONSET LEFT BUNDLE BRANCH BLOCK AFTER TRANSCATHETER AORTIC VALVE IMPLANTATION. EUROPACE (2017) 19, 1015¿1021 DOI: 10.1093/EUROPACE/EUW174 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 SEVERE CONDUCTION DEFECTS REQUIRING PERMANENT PACEMAKER IMPLANTATION IN PATIENTS WITH A NEW-ONSET LEFT BUNDLE BRANCH BLOCK AFTER TRANSCATHETER AORTIC VALVE IMPLANTATION. ALL DATA WERE COLLECTED FROM A SINGLE CENTER BETWEEN JUNE 2007 TO JUNE 2015. THE STUDY POPULATION INCLUDED 627 PATIENTS (EQUALLY MALE AND FEMALE, MEAN AGE OF 81 YEARS WHICH 77 WERE IMPLANTED WITH MEDTRONIC COREVALVE EVOLUTR. AMONG ALL PATIENTS 5 SUDDEN DEATHS OCCURRED. BASED ON THE AVAILABLE INFORMATION, NONE OF THE DEATHS WERE ATTRIBUTED TO MEDTRONIC PRODUCT. AMONG ALL PATIENTS ADVERSE EVENTS INCLUDED: TOTAL AV BLOCK, FIRST- OR SECOND-DEGREE AV BLOCK, ALTERNATING (LEFT AND RIGHT) BUNDLE BRANCH BLOCK, SINUS BRADYCARDIA, MYOCARDIAL INFARCTION, STROKE, BLEEDING (MINOR, MAJOR), PARAVALVULAR LEAK (MILD, MODERATE), ACUTE KIDNEY INJURY. BASED ON THE AVAILABLE INFORMATION, THESE ADVERSE EVENTS MAY HAVE BEEN ATTRIBUTED TO MEDTRONIC PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    574780 EVOLUT R TRANSCATHETER AORTIC VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT MEDTRONIC HEART VALVES DIVISION EVOLUTR-23

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention