BEUDAMED
    FDA Adverse Event Death Summary report: N

    MEDTRONIC TRANSCATHETER VALVE

    MDR report key: 14463936 · Received May 20, 2022

    Report

    Report Number
    2025587-2022-01424
    Event Type
    Death
    Date Received
    May 20, 2022
    Date of Event
    January 3, 2020
    Report Date
    May 20, 2022
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CITATION: FAROUX L, ET AL. CLINICAL IMPACT OF CONDUCTION DISTURBANCES IN TRANSCATHETER AORTIC VALVE REPLACEMENT RECIPIENTS: A SYSTEMATIC REVIEW AND META-ANALYSIS. EUR HEART J. 2020 AUG 1;41(29):2771-2781. DOI: 10.1093/EURHEARTJ/EHZ924. ONLINE PUBLISH-AHEAD-OF-PRINT 3 JANUARY 2020. EARLIEST DATE OF PUBLISH USED FOR DATE OF EVENT AND DATE OF DEATH. APPROVED MEDTRONIC TRANSCATHETER VALVE PRODUCTS REFERENCED: COREVALVE (PMA# P130021, PRODUCT CODE NPT), EVOLUT R (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 · 0

    MEDTRONIC RECEIVED INFORMATION FROM A LITERATURE ARTICLE REGARDING THE IMPACT OF PERI-PROCEDURAL NEW-ONSET PERSISTENT LEFT BUNDLE BRANCH BLOCK (NOP-LBBB) AND PERMANENT PACEMAKER IMPLANTATION (PPI) AFTER TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR). ALL DATA WAS COLLECTED FROM A META-ANALYSIS REVIEW OF 33 STUDIES PUBLISHED BETWEEN 2011 AND 2019. OVERALL, 50,719 PATIENTS WERE INCLUDED IN THE STUDY POPULATION. PATIENT DEMOGRAPHIC DATA WAS NOT REPORTED FOR ALL THE STUDIES INCLUDED IN THE ANALYSIS. AN UNDISCLOSED TOTAL NUMBER OF PATIENTS IN THE STUDY UNDERWENT TAVR WITH A MEDTRONIC TRANSCATHETER VALVE (COREVALVE OR EVOLUT R). NO UNIQUE DEVICE IDENTIFIER NUMBERS WERE PROVIDED. MEDTRONIC TRANSCATHETER VALVES WERE ASSOCIATED WITH NOP-LBBB, NEED FOR PPI, AND HOSPITALIZATION FOR HEART FAILURE AFTER TAVR. INDICATIONS FOR PPI MAY HAVE INCLUDED: THIRD-DEGREE ATRIOVENTRICULAR BLOCK, SECOND-DEGREE ATRIOVENTRICULAR BLOCK, FIRST-DEGREE ATRIOVENTRICULAR BLOCK, HIGH-DEGREE ATRIOVENTRICULAR BLOCK, LBBB, ALTERNATING BBB, BRADYCARDIA, ATRIAL FIBRILLATION WITH INADEQUATE ESCAPE RHYTHM, SICK SINUS SYNDROME, OR SYNCOPE. THE AUTHORS STATED THAT NOP-LBBB AND PPI AFTER TAVRWERE ASSOCIATED WITH AN INCREASED RISK OF ALL-CAUSE DEATH AT ONE-YEAR FOLLOW-UP. ADDITIONALLY, NOP-LBBB AFTER TAVR WAS ASSOCIATED WITH AN INCREASED RISK OF CARDIAC DEATH WITHIN ONE YEAR OF VALVE IMPLANT. AS MEDTRONIC TRANSCATHETER VALVES WERE LINKED WITH THE OCCURRENCE OF NOP-LBBB AND THE NEED FOR PPI AFTER TAVR, IT IS LIKELY THEY WERE A CONTRIBUTORY FACTOR IN SOME OF THESE DEATHS. NO ADDITIONAL ADVERSE PATIENT EFFECTS OR PRODUCT PERFORMANCE ISSUES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1617724 MEDTRONIC TRANSCATHETER VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV NPT MEDTRONIC HEART VALVES DIVISION MDT-TRANS VALVE

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death