BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCUTRAK DELIVERY CATHETER SYSTEM

    MDR report key: 12332002 · Received August 17, 2021

    Report

    Report Number
    2025587-2021-02566
    Event Type
    Injury
    Date Received
    August 17, 2021
    Date of Event
    January 1, 2021
    Report Date
    August 17, 2021
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: ÜSTÜNEL L, ET AL. THE IMPACT OF CLOSURE DEVICES ON VASCULAR COMPLICATIONS DURING TRANSCATHETER AORTIC VALVE IMPLANTATION PROCEDURES IN GERIATRIC PATIENTS. TURKISH JOURNAL OF GERIATRICS. 2021; 24(2): 204-211. DOI: 10.31086/TJGERI.2021.216. EARLIEST DATE OF PUBLISH USED FOR DATE OF EVENT: JANUARY 1, 2021 (YEAR VALID). 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 FROM A LITERATURE ARTICLE REGARDING THE IMPACT OF CLOSURE DEVICES AND SURGICAL EXPLORATION TECHNIQUES ON VASCULAR ACCESS COMPLICATIONS DURING TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR). ALL DATA WAS RETROSPECTIVELY ANALYZED FROM A SINGLE CENTER BETWEEN AUGUST 2014 AND JANUARY 2019. OF THE 169 PATIENTS INCLUDED IN THE STUDY POPULATION (PREDOMINANTLY MALE, MEAN AGE 76.6 YEARS), 21 UNDERWENT TAVR WITH THE MEDTRONIC COREVALVE AND ACCUTRAK DELIVERY CATHETER SYSTEM. NO UNIQUE DEVICE IDENTIFIER NUMBERS WERE PROVIDED. AMONG ALL PATIENTS, 12 POST-OPERATIVE DEATHS OCCURRED. NO STATEMENT WAS MADE SUGGESTING A CAUSAL OR CONTRIBUTORY RELATIONSHIP BETWEEN MEDTRONIC PRODUCT AND THE DEATHS. AMONG ALL PATIENTS, POST-OPERATIVE ADVERSE EVENTS INCLUDED: VASCULAR ACCESS BLEEDING NECESSITATING EMERGENCY SURGERY; AND SURGICAL/ENTRY SITE INFECTION TREATED WITH ANTIBIOTICS. THE ACCUTRAK DELIVERY CATHETER SYSTEM MAY HAVE BEEN ASSOCIATED WITH THESE ADVERSE EVENTS. NO ADDITIONAL ADVERSE PATIENT EFFECTS OR PRODUCT PERFORMANCE ISSUES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1228755 ACCUTRAK DELIVERY CATHETER SYSTEM AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV NPT MEDTRONIC HEART VALVES DIVISION DCS UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention