BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COREVALVE TRANSCATHETER AORTIC VALVE

    MDR report key: 7046544 · Received November 20, 2017

    Report

    Report Number
    2025587-2017-02214
    Event Type
    Injury
    Date Received
    November 20, 2017
    Date of Event
    July 1, 2015
    Report Date
    November 20, 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: O¿SULLIVAN, C. MD ET AL. EFFECT OF PULMONARY HYPERTENSION HEMODYNAMIC PRESENTATION ON CLINICAL OUTCOMES IN PATIENTS WITH SEVERE SYMPTOMATIC AORTIC VALVE STENOSIS UNDERGOING TRANSCATHETER AORTIC VALVE IMPLANTATION. CIRCULATION AND CARDIOVASCULAR INTERVENTIONS (2015). JUL;8(7):E002358 DOI 10.1161/CIRCINTERVENTIONS.114.002358 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).

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION VIA LITERATURE REVIEW REGARDING THE EFFECT OF PULMONARY HYPERTENSION ON CLINICAL OUTCOMES IN PATIENTS AFTER THE IMPLANT OF A TRANSCATHETER BIOPROSTHETIC AORTIC VALVE. ALL DATA WERE COLLECTED FROM A SINGLE CENTER BETWEEN 2007 AND 2012. THE STUDY POPULATION INCLUDED 433 PATIENTS, WHO WERE IMPLANTED WITH EITHER A COREVALVE OR A NON-MEDTRONIC TRANSCATHETER BIOPROSTHETIC VALVE. SERIAL NUMBERS WERE NOT REPORTED. THE STUDY POPULATION WAS PREDOMINANTLY FEMALE; MEAN AGE 82.4 ± 5.3 YEARS. AMONG ALL PATIENTS ADVERSE EVENTS INCLUDED: ATRIAL FIBRILLATION (AFIB), MYOCARDIAL INFARCTION (MI), CEREBRAL VASCULAR ACCIDENT (CVA), GREATER THAN MILD AORTIC REGURGITATION, TRANSIENT ISCHEMIC ATTACK (TIA) AND BLOOD LOSS. 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
    823614 COREVALVE TRANSCATHETER AORTIC VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT MEDTRONIC HEART VALVES DIVISION CRS

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Life Threatening