BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC TRANSCATHETER VALVE

    MDR report key: 11988566 · Received June 12, 2021

    Report

    Report Number
    2025587-2021-01865
    Event Type
    Injury
    Date Received
    June 12, 2021
    Date of Event
    September 4, 2020
    Report Date
    June 11, 2021
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: ELZENEINI M., ET AL. PREDICTORS OF VENTRICULAR PACING BURDEN AFTER PERMANENT PACEMAKER IMPLANTATION FOLLOWING TRANSCATHETER AORTIC VALVE REPLACEMENT. CLIN CARDIOL, 2020 NOV; 43(11): 1334¿1342. PUBLISHED ONLINE 2020 SEP 4. PMID: 32886389. DOI: 10.1002/CLC.23447. EARLIEST DATE OF PUBLISH USED FOR DATE OF EVENT [AND DATE OF DEATH]. [MEDTRONIC PRODUCTS REFERENCED: COREVALVE, EVOLUT R, EVOLUT PRO (PMA# P130021, PRODUCT CODE: NPT). 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 · 1

    MEDTRONIC RECEIVED INFORMATION VIA LITERATURE REGARDING THE PREDICTORS OF VENTRICULAR PACING BURDEN NEEDED AFTER PERMANENT PACEMAKER IMPLANTATION PERFORMED POST-TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR). ALL DATA WERE RETROSPECTIVELY COLLECTED FROM A SINGLE CENTER BETWEEN SEPTEMBER 2013 AND JULY 2019. THE STUDY POPULATION INCLUDED 30 PATIENTS (PREDOMINANTLY MALE, MEAN AGE 76 YEARS), 6 OF WHICH WERE IMPLANTED WITH MEDTRONIC COREVALVE, EVOLUT R OR EVOLUT PRO BIOPROSTHETIC VALVES. (UNIQUE DEVICE IDENTIFIER NUMBERS NOT PROVIDED). AMONG ALL PATIENTS, FOUR DEATHS OCCURRED DURING FOLLOW-UP. NO FURTHER INFORMATION WAS PROVIDED. BASED ON THE AVAILABLE INFORMATION MEDTRONIC PRODUCT WAS NOT DIRECTLY ASSOCIATED WITH THE DEATHS. AMONG ALL PATIENTS, ADVERSE EVENTS INCLUDED: NEW-ONSET LEFT BUNDLE BRANCH BLOCK (LBBB), HIGH-DEGREE ATRIO-VENTRICULAR BLOCK (AVB) AND SYMPTOMATIC BRADYCARDIA, ALL REQUIRING PERMANENT PACEMAKER IMPLANTATION. BASED ON THE AVAILABLE INFORMATION MEDTRONIC PRODUCT MAY HAVE BEEN ASSOCIATED WITH THE ADVERSE EVENTS. NO ADDITIONAL ADVERSE PATIENT EFFECTS OR PRODUCT PERFORMANCE ISSUES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    885198 MEDTRONIC TRANSCATHETER VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV NPT MEDTRONIC HEART VALVES DIVISION MDT-TRANS VALVE

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization| L| R