BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC TRANSCATHETER VALVE

    MDR report key: 14988261 · Received July 12, 2022

    Report

    Report Number
    2025587-2022-01902
    Event Type
    Injury
    Date Received
    July 12, 2022
    Date of Event
    January 12, 2021
    Report Date
    July 12, 2022
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CITATION: PISANIELLO AD, ET AL. LOW RATES OF PERMANENT PACING ARE OBSERVED FOLLOWING SELF-EXPANDING TRANSCATHETER AORTIC VALVE REPLACEMENT USING AN ANNULAR PLANE PROJECTION FOR DEPLOYMENT. CIRC CARDIOVASC INTERV. 2021 JAN;14(1):E009258. DOI: 10.1161/CIRCINTERVENTI ONS.120.009258. EPUB 2021 JAN 12. EARLIEST DATE OF PUBLISH USED FOR DATE OF EVENT. MEDTRONIC PRODUCTS REFERENCED: EVOLUT R (PMA# P130021, PRODUCT CODE NPT), 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 · 0

    MEDTRONIC RECEIVED INFORMATION FROM A LITERATURE ARTICLE REGARDING PERMANENT PACEMAKER IMPLANTATION RATES FOLLOWING TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) USING ANNULAR PLANE PROJECTION FOR DEPLOYMENT. ALL DATA WAS COLLECTED FROM A SINGLE CENTER. THE AUTHORS RETROSPECTIVELY ANALYZED 527 SUCCESSFUL TAVR IMPLANTS PERFORMED BETWEEN JANUARY 2013 AND AUGUST 2019. PATIENTS UNDERWENT TAVR WITH EITHER AN EDWARDS SAPIEN VALVE (N = 434) OR A MEDTRONIC EVOLUT R (N = 50) OR EVOLUT PRO VALVE (N = 43). NO UNIQUE DEVICE IDENTIFIER NUMBERS WERE PROVIDED. THE EVOLUT R/PRO PATIENTS WERE PREDOMINANTLY MALE WITH A MEAN AGE OF 79.6 YEARS. AMONG ALL EVOLUT R/PRO PATIENTS, ADVERSE EVENTS INCLUDED: PERMANENT PACEMAKER IMPLANTATION WITHIN 30 DAYS OF TAVR (EVOLUT R = 3 CASES, EVOLUT PRO = 1 CASE). THE INDICATION FOR PERMANENT PACING WAS COMPLETE HEART BLOCK OR SLOW ATRIAL FIBRILLATION. OTHER ADVERSE EVENTS OBSERVED: VALVE-IN-VALVE IMPLANTATION FOR AN UNKNOWN REASON, NEW LEFT BUNDLE BRANCH BLOCK, AND MODERATE AORTIC REGURGITATION. NO ADDITIONAL ADVERSE PATIENT EFFECTS OR PRODUCT PERFORMANCE ISSUES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    700535 MEDTRONIC TRANSCATHETER VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV NPT MEDTRONIC HEART VALVES DIVISION MDT-TRANS VALVE

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Male Required Intervention