BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COREVALVE REVALVING SYSTEM

    MDR report key: 6664811 · Received June 23, 2017

    Report

    Report Number
    2025587-2017-01033
    Event Type
    Injury
    Date Received
    June 23, 2017
    Date of Event
    May 31, 2017
    Report Date
    June 12, 2017
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: HIDEHIRO KANEKO AND FRANK HOELSCHERMANN, MD ARTICLE TITLE. JAPANESE ASSOCIATION OF CARDIOVASCULAR INTERVENTION AND THERAPEUTICS MAY 31, 2017 10.1007/S12928-017-0473-X DIFFERENT IMPACT OF AORTIC REGURGITATION ASSESSED BY AORTIC ROOT ANGIOGRAPHY AFTER TRANSCATHETER AORTIC VALVE IMPLANTATION ACCORDING TO BASELINE LEFT VENTRICULAR EJECTION FRACTION AND N-TERMINAL PRO-B 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

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION VIA LITERATURE REGARDING THE IMPACT OF AORTIC REGURGITATION FOLLOWING TRANSCATHETER BIOPROSTHETIC VALVE IMPLANTATION (TAVI). ALL DATA WERE COLLECTED FROM A SINGLE CENTER BETWEEN JULY 2008 AND MAY 2015. THE STUDY POPULATION INCLUDED 856 PATIENTS, PREDOMINANTLY MALE, MEAN AGE 81 YEARS, 278 OF WHICH WERE IMPLANTED WITH MEDTRONIC COREVALVE/EVOLUTR. (SERIAL NUMBERS NOT PROVIDED). AMONG ALL PATIENTS, MORTALITY WAS DISCUSSED IN PERCENTAGES BASED ON CERTAIN PHYSICAL FINDINGS. BASED ON THE AVAILABLE INFORMATION, NONE OF THE DEATHS WERE ATTRIBUTED TO MEDTRONIC PRODUCT. AMONG ALL PATIENTS ADVERSE EVENTS INCLUDED: MILD, MODERATE AND SEVERE PARAVALVULAR LEAK (PVL), AORTIC DISSECTION, CEREBRAL INFARCTION, CORONARY OCCLUSION, HEART FAILURE. 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. AMONG ALL PATIENTS DEVICE MALFUNCTIONS INCLUDED: UNDER EXPANSION. MULTIPLE MANUFACTURERS WERE NOTED IN THE LITERATURE; BASED ON THE AVAILABLE INFORMATION A DIRECT CORRELATION COULD NOT BE MADE BETWEEN THE OBSERVED MALFUNCTION AND MEDTRONIC PRODUCT. NO ADDITIONAL ADVERSE PATIENT EFFECTS OR PRODUCT PERFORMANCE ISSUES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    445344 COREVALVE REVALVING SYSTEM AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT MEDTRONIC HEART VALVES DIVISION CRS

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention