BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCUTRAK DELIVERY CATHETER SYSTEM

    MDR report key: 11300567 · Received February 9, 2021

    Report

    Report Number
    2025587-2021-00483
    Event Type
    Injury
    Date Received
    February 9, 2021
    Date of Event
    November 19, 2019
    Report Date
    February 9, 2021
    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

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: KOTRONIAS RA, SCARSINI R, DE MARIA GL, RAJASUNDARAM S, SAYEED R, KRASOPOULOS G, GREBENIK C, KEIRALLA A, NEWTON JD, BANNING AP, KHARBANDA RK. ULTRASOUND GUIDED VASCULAR ACCESS SITE MANAGEMENT AND LEFT VENTRICULAR PACING ARE ASSOCIATED WITH IMPROVED OUTCOMES IN CONTEMPORARY TRANSCATHETER AORTIC VALVE REPLACEMENT: INSIGHTS FROM THE OXTAVI REGISTRY. CATHETER CARDIOVASC INTERV. 2020 AUG;96(2):432-439. DOI: 10.1002/CCD.28578. 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 · 1

    MEDTRONIC RECEIVED INFORMATION VIA LITERATURE REGARDING PREDICTORS OF COMPLICATIONS DURING A TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR). ALL DATA WERE COLLECTED FROM A SINGLE CENTER BETWEEN JANUARY 2015 AND SEPTEMBER 2018. THE STUDY POPULATION INCLUDED 529 PATIENTS (PREDOMINANTLY MALE, MEAN AGE 83 YEARS), 88 OF WHOM WERE IMPLANTED WITH MEDTRONIC COREVALVE (NO SERIAL NUMBERS PROVIDED). AMONG ALL PATIENTS, ADVERSE EVENTS INCLUDED: BLOOD LOSS, MINOR AND MAJOR ACCESS SITE COMPLICATIONS AND PERICARDIAL EFFUSION THAT REQUIRED INTERVENTION. BASED ON THE AVAILABLE INFORMATION A 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
    200903 ACCUTRAK DELIVERY CATHETER SYSTEM AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT MEDTRONIC HEART VALVES DIVISION DCS UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Required Intervention