BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENVEO R DELIVERY SYSTEM

    MDR report key: 6825732 · Received August 28, 2017

    Report

    Report Number
    2025587-2017-01490
    Event Type
    Injury
    Date Received
    August 28, 2017
    Date of Event
    May 30, 2017
    Report Date
    August 4, 2017
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: A. OLASINSKA-WISNIEWSKA ET AL. "FEMORAL ARTERY ANATOMY-TAILORED APPROACH IN TRANSCATHETER AORTIC VALVE IMPLANTATION" ADV INTERV CARDIOL 2017; 13, 2 (48): 150¿156; DOI: HTTPS://DOI.ORG/10.5114/PWKI.2017.68050 EARLIEST DATE OF PUBLISH USED FOR EVENT DATE IN B3. NO UNIQUE DEVICE IDENTIFIER (SERIAL/LOT) NUMBERS WERE PROVIDED; WITHOUT THIS INFORMATION IT COULD NOT BE DETERMINED WHETHER THESE OBSERVATIONS HAVE BEEN PREVIOUSLY REPORTED. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. 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 FEMORAL ARTERY ANATOMY-TAILORED APPROACH IN TRANSCATHETER AORTIC VALVE IMPLANTATION. ALL DATA WERE COLLECTED FROM A SINGLE CENTER BETWEEN SEPTEMBER 2010 AND SEPTEMBER 2015. THE STUDY POPULATION INCLUDED 152 PATIENTS (PREDOMINANTLY FEMALE, MEAN AGE 79 YEARS), 21 WERE IMPLANTED WITH EVOLUT R (SERIAL NUMBERS NOT PROVIDED). AMONG ALL PATIENTS FOUR DEATHS OCCURRED. BASED ON THE AVAILABLE INFORMATION, NONE OF THE DEATHS WERE ATTRIBUTED TO MEDTRONIC PRODUCT. AMONG ALL PATIENTS ADVERSE EVENTS INCLUDED: HEMATOMA, PSEUDOANEURYSM, ACCESS SITE BLEEDING, FEMORAL ARTERY DISSECTION, POST-PROCEDURAL BLEEDING, RETROPERITONEAL BLEEDING, ILIAC ARTERY INJURY WITH MAJOR BLEEDING, MINOR BLEEDING, LIFE-THREATENING BLEEDING. BASED ON THE AVAILABLE INFORMATION, THESE ADVERSE EVENTS MAY HAVE BEEN ATTRIBUTED TO MEDTRONIC PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    605155 ENVEO R DELIVERY SYSTEM AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT MEDTRONIC HEART VALVES DIVISION ENVEOR-L UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Life Threatening| R