BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COREVALVE TRANSCATHETER AORTIC VALVE

    MDR report key: 8684773 · Received June 10, 2019

    Report

    Report Number
    2025587-2019-01877
    Event Type
    Injury
    Date Received
    June 10, 2019
    Date of Event
    May 6, 2019
    Report Date
    June 10, 2019
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: ROA GARRIDO J ET AL. TRANSFEMORAL TAVR AT HOSPITALS WITHOUT ON-SITE CARDIAC SURGERY DEPARTMENT IN SPAIN: A MULTICENTER REGISTRY. JACC CARDIOVASC INTERV. 2019 MAY 13; 12(9): 896-898. DOI: 10.1016/J.JCIN.2019.02.006. EPUB 2019 MAY 6. 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. (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 USE OF TRANSFEMORAL TRANSCATHETER AORTIC VALVE REPLACEMENT IN SPANISH HOSPITALS WITHOUT AN ON-SITE CARDIAC SURGERY DEPARTMENT. ALL DATA WERE COLLECTED FROM 10 CENTERS BETWEEN MAY 2010 AND MAY 2018. THE STUDY POPULATION INCLUDED 384 PATIENTS (PREDOMINANTLY FEMALE; MEAN AGE 82 YEARS), 351 OF WHICH WERE IMPLANTED WITH MEDTRONIC COREVALVE BIOPROSTHETIC VALVES (NO SERIAL NUMBERS PROVIDED). AMONG ALL PATIENTS, THE IN-HOSPITAL MORTALITY WAS 5.2% (20 PATIENTS): 8 CARDIOVASCULAR DEATHS AND 12 NON-CARDIOVASCULAR DEATHS. THE MORTALITY RATE WITHIN 30 DAYS POST IMPLANT WAS 6.1%, WITHIN 1-YEAR POST IMPLANT WAS 12.2%, AND TOTAL MORTALITY DURING FOLLOW-UP WAS 18.7%, RESPECTIVELY. MULTIPLE MANUFACTURERS WERE NOTED IN THE LITERATURE; BASED ON THE AVAILABLE INFORMATION, MEDTRONIC PRODUCT WAS NOT DIRECTLY ASSOCIATED WITH THE DEATHS. AMONG ALL PATIENTS, ADVERSE EVENTS INCLUDED: CONVERSION TO OPEN-HEART SURGERY DUE TO VENTRICULAR PERFORATION AND CARDIAC TAMPONADE (NOTED TO HAVE GOOD OUTCOME FOLLOWING SURGERY), HEART BLOCK REQUIRING PERMANENT PACEMAKER IMPLANTATION, CORONARY OBSTRUCTION, CARDIAC TAMPONADE, VALVE MALPOSITION, VALVE-IN-VALVE IMPLANTATION, AORTIC REGURGITATION (GREATER THAN OR EQUAL TO GRADE 2), MYOCARDIAL INFARCTION, STROKE, AND MAJOR BLEEDING. BASED ON THE AVAILABLE INFORMATION, MEDTRONIC PRODUCT MAY HAVE BEEN 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
    478351 COREVALVE TRANSCATHETER AORTIC VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT MEDTRONIC HEART VALVES DIVISION CRS

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Required Intervention