BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOLUT R TRANSCATHETER AORTIC VALVE

    MDR report key: 6995926 · Received November 2, 2017

    Report

    Report Number
    2025587-2017-01996
    Event Type
    Injury
    Date Received
    November 2, 2017
    Date of Event
    January 1, 2017
    Report Date
    November 2, 2017
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: PERRIN, N. MD ET AL. PARADOXICAL QRS COMPLEX NARROWING FOLLOWING TRANSCATHETER AORTIC VALVE IMPLANTATION. CARDIOVASCULAR MEDICINE (2017). 20(9): 213¿215. NO UNIQUE DEVICE IDENTIFIER (SERIAL/LOT) NUMBERS WERE PROVIDED; WITHOUT THIS INFORMATION, IT CANNOT BE DETERMINED WHETHER THIS EVENT HAS BEEN PREVIOUSLY REPORTED. CONCLUSION: CONDUCTION DISTURBANCES ARE KNOWN POTENTIAL ADVERSE EFFECTS ASSOCIATED WITH ANY CARDIAC OR THORACIC PROCEDURE (OPEN OR CATHETER-BASED) AND CAN BE RESOLVED WITH MEDICAL TREATMENT OR THE IMPLANT OF A PERMANENT PACEMAKER (WITH THE RISK-BENEFIT RATIO IN FAVOR OF IMPLANT OF THE PERCUTANEOUS AORTIC VALVE). A CONDUCTION DISTURBANCE DOES NOT INDICATE A DEVICE MALFUNCTION OR POTENTIAL MANUFACTURING ISSUE. 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 AN (B)(6)-OLD MALE PATIENT WITH A PAST MEDICAL HISTORY OF SEVERE AORTIC STENOSIS AND ATRIAL FIBRILLATION (AFIB) WITH A RIGHT BUNDLE BRANCH BLOCK (RBBB) WHO UNDERWENT IMPLANT OF A MEDTRONIC EVOLUTR TRANSCATHETER BIOPROSTHETIC AORTIC VALVE (SERIAL NUMBER NOT PROVIDED). AFTER THE IMPLANT, AN ECHOCARDIOGRAM INDICATED MILD PARAVALVULAR LEAK (PVL) AND AN ELECTROCARDIOGRAM (ECG) INDICATED TRANSIENT COMPLETE HEART BLOCK (CHB) AND ATRIAL FIBRILLATION (AFIB). SUBSEQUENTLY, A PERMANENT PACEMAKER WAS IMPLANTED TWO DAYS POST VALVE IMPLANT. NO ADDITIONAL ADVERSE PATIENT EFFECTS OR PRODUCT PERFORMANCE ISSUES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    777556 EVOLUT R TRANSCATHETER AORTIC VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT MEDTRONIC HEART VALVES DIVISION EVOLUTR-29

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Required Intervention