BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COREVALVE TRANSCATHETER AORTIC VALVE

    MDR report key: 8389721 · Received March 5, 2019

    Report

    Report Number
    2025587-2019-00807
    Event Type
    Injury
    Date Received
    March 5, 2019
    Date of Event
    May 19, 2015
    Report Date
    March 5, 2019
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: LANSKY, A. MD ET AL. A PROSPECTIVE RANDOMIZED EVALUATION OF THE TRIGUARD TM HDH EMBOLIC DEFLECTION DEVICE DURING TRANSCATHETER AORTIC VALVE IMPLANTATION: RESULTS FROM THE DEFLECT III TRIAL. EUROPEAN HEART JOURNAL (2015) 36, 2070¿2078. DOI: 10.1093/EURHEARTJ/EHV191. 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. 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 USE OF AN EMBOLIC DEFLECTION DEVICE DURING THE IMPLANT OF A TRANSCATHETER BIOPROSTHETIC AORTIC VALVE. ALL DATA WERE COLLECTED FROM MULTIPLE MEDICAL CENTERS BETWEEN FEBRUARY 2014 AND MARCH 2015. THE STUDY POPULATION INCLUDED 85 PATIENTS, 26 OF WHICH WERE IMPLANTED WITH A COREVALVE. THE REMAINING PATIENTS WERE IMPLANTED WITH A NON-MEDTRONIC TRANSCATHETER BIOPROSTHETIC AORTIC VALVE. SERIAL NUMBERS WERE NOT PROVIDED. THE STUDY POPULATION WAS PREDOMINANTLY FEMALE; MEAN AGE 82.4 ± YEARS. AMONG ALL PATIENTS ADVERSE EVENTS INCLUDED: CEREBRAL VASCULAR ACCIDENT (CVA), PERMANENT PACEMAKER IMPLANT, VALVE-IN-VALVE PROCEDURE, AORTIC RUPTURE AND BLOOD LOSS/MAJOR VASCULAR COMPLICATIONS. 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
    183105 COREVALVE TRANSCATHETER AORTIC VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT MEDTRONIC HEART VALVES DIVISION CRS

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Required Intervention