BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COREVALVE TRANSCATHETER AORTIC VALVE

    MDR report key: 8191627 · Received December 21, 2018

    Report

    Report Number
    2025587-2018-03517
    Event Type
    Injury
    Date Received
    December 21, 2018
    Date of Event
    April 27, 2018
    Report Date
    December 21, 2018
    Manufacturer
    HEART VALVES SANTA ANA
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: SHINN ET AL. "A SYSTEMIC REVIEW AND META-ANALYSIS OF SUTURELESS AORTIC VALVE REPLACEMENT VERSUS TRANSCATHETER AORTIC VALVE IMPLANTATION." ANN THORAC SURG. 2018 SEP; 106 (3): 924-929. DOI: 10.1016/J.ATHORACSUR.2018.03.059. EPUB 2018 APR 27. 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 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 SYSTEMIC REVIEW AND META-ANALYSIS OF SUTURELESS AORTIC VALVE REPLACEMENT VERSUS TRANSCATHETER AORTIC VALVE IMPLANTATION. ALL DATA WERE COLLECTED FROM MULTIPLE DATABASES BETWEEN JANUARY 2000 TO OCTOBER 2016. OF SEVEN OBSERVATIONAL STUDIES REFERENCED, THE AGGREGATE STUDY POPULATION WAS 1238 PATIENTS (PREDOMINANTLY FEMALE, MEAN AGE 79 YEARS) IN WHICH 617 WERE IMPLANTED WITH A SUTURELESS AORTIC VALVE AND 621 WERE IMPLANTED WITH A TRANSCATHETER AORTIC VALVE. MEDTRONIC VALVES REPRESENTED INCLUDED COREVALVE TRANSCATHETER BIOPROSTHETIC VALVE (NO SERIAL NUMBERS PROVIDED). AMONG ALL PATIENTS, EARLY MORTALITY WAS 2.5% AND 5% IN THE SUTURELESS AND TRANSCATHETER COHORTS, RESPECTIVELY. IN ONE STUDY, AMONG ALL COREVALVE PATIENTS 1.8% MORTALITY OCCURRED. BASED ON THE AVAILABLE INFORMATION, MEDTRONIC PRODUCT DID NOT CAUSE OR CONTRIBUTE THESE DEATHS. AMONG ALL PATIENTS, ADVERSE EVENTS INCLUDED: POSTPROCEDURAL PARAVALVULAR LEAK, STROKE, ARRHYTHMIA REQUIRING PERMANENT PACEMAKER IMPLANT, AND PERIPHERAL VASCULAR COMPLICATION. MULTIPLE MANUFACTURERS WERE NOTED IN THE LITERATURE; BASED ON THE AVAILABLE INFORMATION A DIRECT CORRELATION COULD NOT BE MADE BETWEEN MEDTRONIC PRODUCT AND THE OBSERVED ADVERSE EVENTS. NO ADDITIONAL ADVERSE PATIENT EFFECTS OR PRODUCT PERFORMANCE ISSUES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1030416 COREVALVE TRANSCATHETER AORTIC VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT HEART VALVES SANTA ANA CRS

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention