BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COREVALVE TRANSCATHETER AORTIC VALVE

    MDR report key: 6939787 · Received October 11, 2017

    Report

    Report Number
    2025587-2017-01809
    Event Type
    Injury
    Date Received
    October 11, 2017
    Date of Event
    February 11, 2015
    Report Date
    September 28, 2017
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: BERNARDI, F. MD. SURGICAL CUTDOWN VERSUS PERCUTANEOUS ACCESS IN TRANSFEMORAL TRANSCATHETER AORTIC VALVE IMPLANTATION: INSIGHTS FROM THE BRAZILIAN TAVI REGISTRY. CATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS; (2105). 86(3):501-5. DOI 10.1002/CCD.25820 EARLIEST DATE OF E-PUBLISH/PUBLISH USED FOR EVENT DATE. NO UNIQUE DEVICE IDENTIFIER (SERIAL/LOT) NUMBERS WERE PROVIDED; WITHOUT THIS INFORMATION, IT CANNOT BE DETERMINED WHETHER THIS EVENT HAS BEEN PREVIOUSLY REPORTED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION VIA LITERATURE REVIEW REGARDING 1-YEAR OUTCOMES OF COMPLETE PERCUTANEOUS APPROACH VERSUS SURGICAL VASCULAR APPROACH FOR TRANSFEMORAL TRANSCATHETER AORTIC VALVE IMPLANTATION. ALL DATA WERE COLLECTED FROM A MULTI-CENTER REGISTRY BETWEEN 2008 AND 2013. THE STUDY POPULATION INCLUDED 402 PATIENTS (PREDOMINANTLY FEMALE; MEAN AGE 81 YEARS). PATIENT WERE IMPLANTED WITH EITHER A COREVALVE OR A NON-MEDTRONIC BALLOON EXPANDABLE TRANSCATHETER BIOPROSTHETIC AORTIC VALVE VIA PERCUTANEOUS (182) OR SURGICAL VASCULAR (220) APPROACH. SERIAL NUMBERS WERE NOT PROVIDED. AMONG ALL PATIENTS ADVERSE EVENTS INCLUDED: VALVE DISLODGMENT/MIGRATION, IMPLANT OF A SECOND VALVE, MODERATE TO SEVERE PERI-VALVULAR LEAK, CEREBROVASCULAR ACCIDENT, CORONARY OBSTRUCTION, VASCULAR COMPLICATION, BLOOD LOSS AND VALVE RELATED REPEAT PROCEDURE. BASED ON THE AVAILABLE INFORMATION, THESE EVENTS MAY HAVE BEEN ATTRIBUTED TO MEDTRONIC PRODUCT. HOWEVER AS MULTIPLE MANUFACTURERS WERE NOTED IN THE LITERATURE, A DIRECT CORRELATION COULD NOT BE MADE BETWEEN THE OBSERVED ADVERSE EVENTS AND THE MEDTRONIC PRODUCT. NO ADDITIONAL ADVERSE PATIENT EFFECTS OR PRODUCT PERFORMANCE ISSUES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    721420 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