BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOLUT R TRANSCATHETER AORTIC VALVE

    MDR report key: 9235952 · Received October 24, 2019

    Report

    Report Number
    2025587-2019-03265
    Event Type
    Injury
    Date Received
    October 24, 2019
    Date of Event
    August 23, 2019
    Report Date
    October 24, 2019
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: MOSLEH W ET AL. COMPARATIVE OUTCOMES OF BALLOON-EXPANDABLE S3 VERSUS SELF-EXPANDING EVOLUT BIOPROSTHESES FOR TRANSCATHETER AORTIC VALVE IMPLANTATION. AM J CARDIOL. 2019 AUG 23. PII: S0002-9149(19)30954-3. DOI: 10.1016/J.AMJCARD.2019.08.014. EARLIEST DATE OF PUBLISH USED FOR EVENT DATE. 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 THE RETURN OF THE PRODUCT, NO DEFINITIVE CONCLUSION CAN BE MADE REGARDING THE CLINICAL OBSERVATIONS. ADDITIONAL PATIENT CODE(S): (B)(4). 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 A COMPARISON OF THE SAFETY, EFFICACY, AND PROCEDURAL EFFICIENCY OF THE EDWARDS SAPIEN S3 VERSUS THE MEDTRONIC EVOLUT BIOPROSTHESES IN PATIENTS WHO UNDERWENT TRANSCATHETER AORTIC VALVE IMPLANTATION FOR SEVERE AORTIC STENOSIS. ALL DATA WERE RETROSPECTIVELY COLLECTED FROM A SINGLE CENTER BETWEEN SEPTEMBER 2015 AND JANUARY 2019. THE STUDY POPULATION INCLUDED 581 PATIENTS (PREDOMINANTLY MALE; MEAN AGE 82 YEARS; 97% WHITE), 129 WERE IMPLANTED WITH MEDTRONIC EVOLUT R (72) OR EVOLUT PRO (57) BIOPROSTHETIC VALVES. NO SERIAL NUMBERS WERE PROVIDED. AMONG ALL EVOLUT R AND EVOLUT PRO PATIENTS, THE IN-HOSPITAL AND 30-DAY MORTALITY INCLUDED 1 AND 3 PATIENTS, RESPECTIVELY. NO OTHER DETAILS WERE REPORTED. BASED ON THE AVAILABLE INFORMATION, MEDTRONIC PRODUCT WAS NOT DIRECTLY ASSOCIATED WITH THE DEATHS. AMONG ALL EVOLUT R AND EVOLUT PRO PATIENTS, ADVERSE EVENTS INCLUDED: PERMANENT PACEMAKER IMPLANTATION, STROKE/TRANSIENT ISCHEMIC ATTACK (3 IN-HOSPITAL, 3 WITHIN 30 DAYS POST IMPLANT), CARDIAC ARREST DURING THE PROCEDURE, BLEEDING/VASCULAR COMPLICATIONS, MILD-MODERATE AORTIC REGURGITATION, AND PROSTHESIS-PATIENT MISMATCH. BASED ON THE AVAILABLE INFORMATION, MEDTRONIC PRODUCT WAS DIRECTLY 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
    1029200 EVOLUT R TRANSCATHETER AORTIC VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT MEDTRONIC HEART VALVES DIVISION EVOLUTR-23

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Required Intervention