BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOLUT R TRANSCATHETER AORTIC VALVE

    MDR report key: 8200861 · Received December 27, 2018

    Report

    Report Number
    2025587-2018-03558
    Event Type
    Injury
    Date Received
    December 27, 2018
    Date of Event
    November 28, 2017
    Report Date
    January 8, 2019
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTED DATA: DATE MFR REC: 2019-01-02. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE PHYSICIAN/AUTHOR STATED THAT MEDTRONIC PRODUCT DID NOT CAUSE OR CONTRIBUTE TO THE OBSERVED ADVERSE EVENTS. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    CITATION: DZIEWIERZ A ET AL. IMPACT OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE AND FRAILTY ON LONG-TERM OUTCOMES AND QUALITY OF LIFE AFTER TRANSCATHETER AORTIC VALVE IMPLANTATION. AGING CLIN EXP RES. 2018 SEP;30(9):1033-1040. DOI: 10.1007/S40520-017-0864-Y. EPUB 2017 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 THE IMPACT OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD) ON LONG-TERM OUTCOMES AND QUALITY OF LIFE IN PATIENTS WITH SEVERE AORTIC STENOSIS UNDERGOING TRANSCATHETER AORTIC VALVE IMPLANTATION. ALL DATA WERE COLLECTED FROM A SINGLE CENTER. THE STUDY POPULATION INCLUDED 148 PATIENTS (PREDOMINANTLY FEMALE; MEAN AGE 82 YEARS), 29 OF WHICH WERE IMPLANTED WITH EITHER A MEDTRONIC COREVALVE BIOPROSTHETIC VALVE OR A MEDTRONIC EVOLUT R BIOPROSTHETIC VALVE. NO SERIAL NUMBERS WERE PROVIDED. THE 30-DAY AND 12-MONTH ALL-CAUSE MORTALITY RATES WERE REPORTED FOR PATIENTS WITHOUT COPD AND PATIENTS WITH COPD:7.8% AND 10.5%, 11.6% AND 36.8%, RESPECTIVELY. BASED ON THE AVAILABLE INFORMATION, MEDTRONIC PRODUCT DID NOT CAUSE OR CONTRIBUTE TO THESE DEATHS. AMONG ALL PATIENTS, ADVERSE EVENTS INCLUDED: NEW PERMANENT PACEMAKER IMPLANTATION, MYOCARDIAL INFARCTION, CEREBROVASCULAR ACCIDENT, NEW ONSET OF ATRIAL FIBRILLATION, AND MILD/MODERATE/SEVERE (GRADE 1, 2, OR 3) AORTIC REGURGITATION. 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
    1038219 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