BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC TRANSCATHETER VALVE

    MDR report key: 14782993 · Received June 22, 2022

    Report

    Report Number
    2025587-2022-01757
    Event Type
    Injury
    Date Received
    June 22, 2022
    Date of Event
    June 7, 2021
    Report Date
    June 22, 2022
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CITATION: TESTA ET AL. TRANSCATHETER AORTIC VALVE REPLACEMENT FOR DEGENERATED TRANSCATHETER AORTIC VALVES: THE TRANSIT INTERNATIONAL PROJECT. CIRC CARDIOVASC INTERV. 2021 JUN;14(6):E010440. DOI: 10.1161/CIRCINTERVENTIONS.120.010440. EPUB 2021 JUN 7. EARLIEST DATE OF PUBLICATION USED FOR DATE OF EVENT. MEDTRONIC PRODUCTS REFERENCED: COREVALVE, EVOLUT R. 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 TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) FOR DEGENERATED TRANSCATHETER AORTIC VALVES. ALL DATA WERE COLLECTED FROM 28 CENTERS ENROLLED IN AN INVESTIGATOR-INITIATED REGISTRY STARTED IN JANUARY 2020. THE STUDY POPULATION INCLUDED 172 PATIENTS WHO WERE PREDOMINANTLY MALE WITH A MEAN AGE OF 79.9 YEARS. MULTIPLE MANUFACTURER¿S DEVICES WERE IMPLANTED IN THE STUDY POPULATION. FOR THE FIRST BIOPROSTHETIC VALVE, 84 OF THE 172 PATIENTS WERE IMPLANTED WITH A MEDTRONIC COREVALVE (N=37) OR EVOLUT R (N = 47) BIOPROSTHETIC VALVE. FOR THE SECOND VALVE, 87 OF THE 172 PATIENTS WERE IMPLANTED WITH A MEDTRONIC EVOLUT R BIOPROSTHETIC VALVE. NO UNIQUE DEVICE IDENTIFIER NUMBERS WERE PROVIDED. AMONG ALL PATIENTS, 7 PERI-PROCEDURAL DEATHS AND 12 DEATHS WITHIN 30 DAYS OF IMPLANT OCCURRED. NO FURTHER DETAILS WERE PROVIDED ON THE DEATHS. THERE WAS NO STATEMENT OF CAUSAL OR CONTRIBUTORY RELATIONSHIP BETWEEN MEDTRONIC PRODUCT AND THE DEATHS. AMONG ALL PATIENTS, ADVERSE EVENTS INCLUDED: ANNULUS RUPTURE, MAJOR VASCULAR COMPLICATION, MAJOR BLEEDING, SEVERE AORTIC REGURGITATION (AR), ARRHYTHMIA REQUIRING PERMANENT PACEMAKER IMPLANT, MEAN GRADIENTS GREATER THAN 20 MMHG, SEPSIS, CONGESTIVE HEART FAILURE (CHF), MYOCARDIAL INFARCTION (MI), STROKE, TRANSIENT ISCHEMIC ATTACK (TIA), AND VALVE THROMBOSIS. 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
    256949 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| L| H