BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COREVALVE REVALVING SYSTEM

    MDR report key: 6272474 · Received January 24, 2017

    Report

    Report Number
    2025587-2017-00135
    Event Type
    Injury
    Date Received
    January 24, 2017
    Date of Event
    August 8, 2016
    Report Date
    January 7, 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: ALAIDE CHIEFFO, MD ARTICLE TITLE: ACUTE AND 30-DAY OUTCOMES IN WOMEN AFTER TAVR JOURNAL TITLE: JACC: CARDIOVASCULAR INTERVENTIONS 2016; 9(15):1589-600: 10.1016/J.JCIN.2016.05.015 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. 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.

    Additional Manufacturer Narrative · 1

    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 TO EXAMINE THE SAFETY AND PERFORMANCE OF TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) USING AN ALL-FEMALE REGISTRY AND TO FURTHER EXPLORE THE POTENTIAL IMPACT OF FEMALE SEX-SPECIFIC CHARACTERISTICS ON CLINICAL OUTCOMES AFTER TAVR. ALL DATA WERE COLLECTED FROM MULTIPLE CENTERS BETWEEN JANUARY 2013 AND DECEMBER 2015. THE STUDY POPULATION INCLUDED 1019 FEMALE PATIENTS; MEAN AGE 83 YEARS, 461 OF WHICH WERE IMPLANTED WITH MEDTRONIC COREVALVE/EVOLUT R (SERIAL NUMBERS NOT PROVIDED). AMONG ALL PATIENTS ADVERSE EVENTS INCLUDED: STROKE, VASCULAR COMPLICATIONS, BLEEDING, DISLODGED VALVE, ANNULUS OR AORTIC RUPTURE, VENTRICULAR PERFORATION, COMPLETE HEART BLOCK (CHB), MYOCARDIAL INFARCTION (MI), CORONARY OBSTRUCTION, VALVE-IN-VALVE, SURGICAL CONVERSION, ACUTE KIDNEY INJURY, ATRIAL FIBRILLATION, LEFT BUNDLE BRANCH BLOCK (LBBB), PERMANENT PACEMAKER IMPLANT. MULTIPLE MANUFACTURERS WERE NOTED IN THE LITERATURE; BASED ON THE AVAILABLE INFORMATION A DIRECT CORRELATION COULD NOT BE MADE BETWEEN THE OBSERVED ADVERSE EVENTS AND MEDTRONIC PRODUCT. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    55866 COREVALVE REVALVING SYSTEM AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT MEDTRONIC HEART VALVES DIVISION CRS

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Required Intervention