BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COREVALVE TRANSCATHETER AORTIC VALVE

    MDR report key: 6954689 · Received October 17, 2017

    Report

    Report Number
    2025587-2017-01857
    Event Type
    Injury
    Date Received
    October 17, 2017
    Date of Event
    May 29, 2015
    Report Date
    October 17, 2017
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: CHIEFFO, A. MD. IMPACT OF MIXED AORTIC VALVE STENOSIS ON VARC-2 OUTCOMES AND POSTPROCEDURAL AORTIC REGURGITATION IN PATIENTS UNDERGOING TRANSCATHETER AORTIC VALVE IMPLANTATION. CATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS (2015) 86:875¿885 DOI 10.1002/CCD.25975 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. (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION VIA LITERATURE REVIEW REGARDING THE IMPACT OF MIXED AORTIC VALVE STENOSIS ON OUTCOMES AND AORTIC REGURGITATION AFTER THE IMPLANT OF A TRANSCATHETER BIOPROSTHETIC AORTIC VALVE. ALL DATA WERE COLLECTED FROM A MULTI-CENTER, MULTI-COUNTRY REGISTRY BETWEEN 2005 AND 2011. THE STUDY POPULATION INCLUDED 1,062 PATIENTS, WHICH WERE IMPLANTED WITH EITHER A COREVALVE OR A NON- MEDTRONIC BALLOON EXPANDABLE TRANSCATHETER BIOPROSTHETIC AORTIC VALVE. THE STUDY POPULATION WAS PREDOMINANTLY MALE; MEAN AGE 81 ± 7.1 YEARS. SERIAL NUMBERS WERE NOT PROVIDED. AMONG ALL PATIENTS ADVERSE EVENTS INCLUDED: CORONARY OBSTRUCTION, MYOCARDIAL INFARCTION (MI), TRANSIENT ISCHEMIC ATTACK (TIA), CEREBRAL VASCULAR ACCIDENT (CVA), VASCULAR COMPLICATIONS, BLOOD LOSS, ELECTROCARDIOGRAM (ECG) CHANGES WITH PERMANENT PACEMAKER IMPLANT, VALVE-IN-VALVE IMPLANT AND MILD TO SEVERE PARAVALVULAR LEAK (PVL). BASED ON THE AVAILABLE INFORMATION, THESE EVENTS MAY HAVE BEEN ATTRIBUTED TO A 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
    735057 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