BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC TRANSCATHETER VALVE

    MDR report key: 13067001 · Received December 22, 2021

    Report

    Report Number
    2025587-2021-03832
    Event Type
    Injury
    Date Received
    December 22, 2021
    Date of Event
    February 10, 2020
    Report Date
    December 22, 2021
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CITATION: ALPASLAN ET AL. NEW RISK FACTORS IN DETERMINING LONG-TERM MORTALITY IN PATIENTS UNDERGOING TAVI: CAN THE CONVENTIONAL RISK SCORES BE USED AS A LONG-TERM MORTALITY PREDICTOR? (B)(6). (B)(6) 2020; 78(3):219-226. DOI: (B)(4). EPUB(B)(4), (B)(6) 2020. EARLIEST DATE OF PUBLISH USED FOR DATE OF EVENT. NO UNIQUE DEVICE IDENTIFIER (SERIAL/LOT) NUMBERS WERE PROVIDED; WITHOUT THIS INFORMATION IT COULD NOT BE DETERMINED WHETHER THESE OBSERVATIONS HAVE BEEN PREVIOUSLY REPORTED. WITHOUT RETURN OF THE PRODUCT NO DEFINITIVE CONCLUSION CAN BE MADE REGARDING THE CLINICAL OBSERVATIONS. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    MEDTRONIC RECEIVED INFORMATION VIA LITERATURE REGARDING NEW RISK FACTORS IN DETERMINING LONG-TERM MORTALITY IN PATIENTS UNDERGOING TRANSCATHETER AORTIC VALVE IMPLANTATION (TAVI). ALL DATA WERE COLLECTED FROM MULTIPLE CENTERS BETWEEN JUNE 2012 AND MARCH 2016. THE STUDY POPULATION INCLUDED 121 PATIENTS (PREDOMINANTLY FEMALE, MEAN (B)(6). MULTIPLE MANUFACTURER¿S DEVICES WERE IMPLANTED IN THE STUDY POPULATION. EIGHTY-EIGHT PATIENTS WERE IMPLANTED WITH A MEDTRONIC COREVALVE OR EVOLUT R BIOPROSTHETIC VALVE (UNIQUE DEVICE IDENTIFIER NUMBERS NOT PROVIDED). AMONG ALL PATIENTS, TWO DEATHS OCCURRED IN-HOSPITAL AND 26 DEATHS OCCURRED DURING FOLLOW-UP. NO STATEMENT WAS MADE INDICATING A CAUSAL OR CONTRIBUTORY RELATIONSHIP BETWEEN MEDTRONIC PRODUCT AND THE DEATH(S). BASED ON THE AVAILABLE INFORMATION MEDTRONIC PRODUCT WAS NOT DIRECTLY ASSOCIATED WITH THE DEATH(S). AMONG ALL PATIENTS, ADVERSE EVENTS INCLUDED: VASCULAR COMPLICATION, CORONARY OBSTRUCTION, NEW LEFT BUNDLE BRANCH BLOCK (LBBB), MODERATE TO SEVERE PARAVALVULAR LEAK (PVL) OR AORTIC REGURGITATION (AR), ARRHYTHMIA REQUIRING PERMANENT PACEMAKER IMPLANT, STROKE, AND VENTRICULAR SEPTAL DEFECT. BASED ON THE AVAILABLE INFORMATION MEDTRONIC PRODUCT MAY HAVE BEEN ASSOCIATED WITH THE ADVERSE EVENT(S). NO ADDITIONAL ADVERSE PATIENT EFFECTS OR PRODUCT PERFORMANCE ISSUES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1961058 MEDTRONIC TRANSCATHETER VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV NPT MEDTRONIC HEART VALVES DIVISION MDT-TRANS VALVE

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Female Life Threatening| R