BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOLUT R TRANSCATHETER AORTIC VALVE

    MDR report key: 8233359 · Received January 10, 2019

    Report

    Report Number
    2025587-2019-00132
    Event Type
    Injury
    Date Received
    January 10, 2019
    Date of Event
    November 28, 2018
    Report Date
    January 9, 2019
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: ABDELGHANI M ET AL. BIOPROSTHETIC VALVE PERFORMANCE AFTER TRANSCATHETER AORTIC VALVE REPLACEMENT WITH SELF-EXPANDING VERSUS BALLOON-EXPANDABLE VALVES IN LARGE VERSUS SMALL AORTIC VALVE ANNULI: INSIGHTS FROM THE CHOICE TRIAL AND THE CHOICE-EXTEND REGISTRY. JACC CARDIOVASC INTERV. 2018 DEC 24; 11 (24):2507-2518. DOI: 10.1016/J.JCIN.2018.07.050. EPUB 2018 NOV 28. 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. (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 SELF-EXPANDING AND BALLOON-EXPANDABLE TRANSCATHETER HEART VALVES IN LARGE VERSUS SMALL AORTIC VALVE ANNULI. ALL DATA WERE COLLECTED FROM MULTIPLE CENTERS BETWEEN MARCH 2012 AND MARCH 2014. THE STUDY POPULATION INCLUDED 635 PATIENTS (PREDOMINANTLY FEMALE; MEAN AGE 81 YEARS), 120 OF WHICH WERE IMPLANTED WITH A MEDTRONIC COREVALVE BIOPROSTHETIC VALVE AND 135 WERE IMPLANTED WITH A MEDTRONIC EVOLUT R BIOPROSTHETIC VALVE (23, 26, 29, 31, AND 34 MM PROSTHESIS SIZES WERE USED). NO SERIAL NUMBERS WERE PROVIDED. AMONG ALL PATIENTS, 31 DEATHS OCCURRED. MULTIPLE MANUFACTURERS WERE NOTED IN THE LITERATURE; BASED ON THE LIMITED AVAILABLE INFORMATION, MEDTRONIC PRODUCT DID NOT CAUSE OR CONTRIBUTE TO THESE DEATHS. AMONG ALL PATIENTS, ADVERSE EVENTS INCLUDED: NEW PERMANENT PACEMAKER IMPLANTATION (REPORTED FOR EVOLUT R AND EDWARDS SAPIEN 3 RECIPIENTS), VALVE-IN-VALVE PROCEDURES, CEREBROVASCULAR ACCIDENT/STROKE, TRANSIENT ISCHEMIC ATTACK (REPORTED FOR EVOLUT R AND EDWARDS SAPIEN 3 RECIPIENTS), PROSTHESIS-PATIENT MISMATCH, MILD-MODERATE-SEVERE PARAVALVULAR REGURGITATION, MAJOR VASCULAR COMPLICATIONS, LIFE-THREATENING/MAJOR BLEEDING, AND ELEVATED TRANSVALVULAR MEAN PRESSURE GRADIENTS. MULTIPLE MANUFACTURERS WERE NOTED IN THE LITERATURE; HOWEVER, BASED ON THE AVAILABLE INFORMATION, MEDTRONIC PRODUCT MAY HAVE CAUSED OR CONTRIBUTED TO 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
    31129 EVOLUT R TRANSCATHETER AORTIC VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT MEDTRONIC HEART VALVES DIVISION EVOLUTR-23

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention