BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC TRANSCATHETER VALVE

    MDR report key: 13773812 · Received March 15, 2022

    Report

    Report Number
    2025587-2022-00688
    Event Type
    Injury
    Date Received
    March 15, 2022
    Date of Event
    February 5, 2022
    Report Date
    March 15, 2022
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CITATION: KAKUTA ET AL. TRANSAORTIC TRANSCATHETER AORTIC VALVE REPLACEMENT IN PATIENTS FROM A SINGLE INSTITUTION: FEASIBILITY, SAFETY, AND MIDTERM OUTCOMES. CIRC J. 2022 FEB 25;86(3):393-401. DOI: 10.1253/CIRCJ.CJ-21-0877. EPUB 2022 FEB 5. EARLIEST DATE OF PUBLISH USED FOR DATE OF EVENT. MEDTRONIC PRODUCTS REFERENCED: COREVALVE, EVOLUT R, EVOLUT PRO, EVOLUT PRO+. EARLIEST APPROVED PRODUCT USED FOR PRODUCT CODE AND PMA#. 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 FEASIBILITY, SAFETY AND OUTCOMES FOR PATIENTS WHO UNDERWENT TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR). ALL DATA WERE COLLECTED FROM A SINGLE JAPANESE MEDICAL CENTER FROM 2011 TO 2021. THE STUDY POPULATION INCLUDED 84 PATIENTS (PREDOMINANTLY FEMALE, MEDIAN AGE 83 YEARS). MULTIPLE MANUFACTURER¿S DEVICES WERE IMPLANTED IN THE STUDY POPULATION. AMONG ALL PATIENTS 38 WERE IMPLANTED WITH A MEDTRONIC COREVALVE (N=18), EVOLUT R (N=13), EVOLUT PRO (N=3) OR EVOLUT PRO+ (N=4) BIOPROSTHETIC VALVE (UNIQUE DEVICE IDENTIFIER NUMBERS NOT PROVIDED). AMONG ALL PATIENTS, ONE IN-HOSPITAL DEATH OCCURRED DUE TO PREOPERATIVE CARDIOGENIC SHOCK. DURING THE FOLLOW-UP PERIOD WITH A MEDIAN 1.5 YEARS, SEVEN ALL-CAUSE DEATHS OCCURRED. NO FURTHER DETAILS WERE PROVIDED ON THESE DEATHS. BASED ON THE AVAILABLE INFORMATION MEDTRONIC PRODUCT WAS NOT DIRECTLY ASSOCIATED WITH THE DEATH(S). AMONG ALL PATIENTS, ADVERSE EVENTS INCLUDED: VALVE MIGRATION, UNSPECIFIED AORTIC INJURY, HIGH GRADIENTS (>20 MMHG), MODERATE PARAVAL VULAR LEAK (PVL), ARRHYTHMIA REQUIRING PERMANENT PACEMAKER IMPLANT, CARDIAC TAMPONADE, PLEURAL CAVITY BLEEDING, CEREBROVASCULAR EVENTS, BACTEREMIA INFECTION, ENDOCARDITIS. SOME OF THESE PATIENTS REQUIRED CONVERSION TO SURGERY OR FULL STERNOTOMY, OR WERE LATER RE- HOSPITALIZED FOR PROCEDURE-RELATED OR VALVE-RELATED COMPLICATIONS. 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
    779686 MEDTRONIC TRANSCATHETER VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV NPT MEDTRONIC HEART VALVES DIVISION MDT-TRANS VALVE

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Female Life Threatening| H| R