BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC TRANSCATHETER VALVE

    MDR report key: 12708328 · Received October 27, 2021

    Report

    Report Number
    2025587-2021-03189
    Event Type
    Injury
    Date Received
    October 27, 2021
    Date of Event
    March 30, 2021
    Report Date
    October 27, 2021
    Manufacturer
    HEART VALVES SANTA ANA
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    CITATION: FERRERIA ET AL. PREDICTORS OF HIGH-DEGREE CONDUCTION DISTURBANCES AND PACEMAKER IMPLANTATION AFTER TRANSCATHETER AORTIC VALVE REPLACEMENT: PROGNOSTIC ROLE OF THE ELECTROPHYSIOLOGICAL STUDY. PACING CLIN ELECTROPHYSIOL. 2021 MAY;44(5):843-855. DOI: 10.1111/PACE.14225. EPUB 2021 MAR 30. 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 PREDICTORS OF HIGH-DEGREE CONDUCTION DISTURBANCES AND PACEMAKER IMPLANTATION AFTER TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR). ALL DATA WERE COLLECTED FROM A SINGLE CENTER BETWEEN JUNE 2018 AND JULY 2019. THE STUDY POPULATION INCLUDED 74 PATIENTS (PREDOMINANTLY FEMALE, MEAN AGE 82 YEARS). MULTIPLE MANUFACTURER¿S DEVICES WERE IMPLANTED IN THE STUDY POPULATION. AMONG ALL PATIENTS, 36 WERE IMPLANTED WITH A MEDTRONIC EVOLUT R OR EVOLUT PRO BIOPROSTHETIC VALVE (UNIQUE DEVICE IDENTIFIER NUMBERS NOT PROVIDED). AMONG ALL PATIENTS, FIVE DEATHS OCCURRED, TWO DURING HOSPITALIZATION AND THREE DURING FOLLOW-UP. 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 MEDTRONIC EVOLUT PATIENTS, ADVERSE EVENTS INCLUDED: FIRST, SECOND AND THIRD DEGREE ATRIO-VENTRICULAR (AV) BLOCK, ATRIAL FI BRILLATION (AFIB), LEFT ANTERIOR HEMIBLOCK, LEFT BUNDLE BRANCH BLOCK (LBBB), RIGHT BUNDLE BRANCH BLOCK (RBBB), AND NEED FOR PERMANENT PACEMAKER IMPLANT. BASED ON THE AVAILABLE INFORMATION MEDTRONIC PRODUCT WAS 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
    1604828 MEDTRONIC TRANSCATHETER VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV NPT HEART VALVES SANTA ANA MDT-TRANS VALVE

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Life Threatening| R