BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COREVALVE TRANSCATHETER AORTIC VALVE

    MDR report key: 6891089 · Received September 25, 2017

    Report

    Report Number
    2025587-2017-01677
    Event Type
    Injury
    Date Received
    September 25, 2017
    Date of Event
    February 3, 2015
    Report Date
    September 19, 2017
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: ARAI, TAKAHIDE MD ET AL. IMPACT OF PRE- AND POST-PROCEDURAL ANEMIA ON THE INCIDENCE OF ACUTE KIDNEY INJURY AND 1-YEAR MORTALITY IN PATIENTS UNDERGOING TRANSCATHETER AORTIC VALVE IMPLANTATION (FROM THE FRENCH AORTIC NATIONAL COREVALVE AND EDWARDS 2 [FRANCE 2] REGISTRY) CATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS (2015) 85:1231¿1239. DOI 10.1002/CCD.25832 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. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. 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 ANEMIA ON THE INCIDENCE OF ACUTE KIDNEY INJURY AND ONE YEAR MORTALITY AFTER THE IMPLANT OF A TRANSCATHETER BIOPROSTHETIC AORTIC VALVE. ALL DATA WERE COLLECTED FROM MULTI-CENTER AND MULTI-COUNTRY REGISTRY. THE STUDY POPULATION INCLUDED 3,742 PATIENTS (PREDOMINATELY MALE, MEAN AGE 82 YEARS) THAT WERE IMPLANTED WITH EITHER A MEDTRONIC COREVALVE OR A NON MEDTRONIC BALLOON EXPANDABLE VALVE (SERIAL NUMBERS NOT PROVIDED). AMONG ALL PATIENTS ADVERSE EVENTS INCLUDED: CEREBRAL VASCULAR ACCIDENT (CVA), VASCULAR COMPLICATIONS, BLEEDING AND VALVE-IN-VALVE IMPLANT. NO ADDITIONAL ADVERSE PATIENT EFFECTS OR PRODUCT PERFORMANCE ISSUES WERE REPORTED. 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 WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    669697 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