BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COREVALVE TRANSCATHETER AORTIC VALVE

    MDR report key: 12356589 · Received August 23, 2021

    Report

    Report Number
    2025587-2021-02629
    Event Type
    Injury
    Date Received
    August 23, 2021
    Date of Event
    December 18, 2020
    Report Date
    August 23, 2021
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: BUZZATTI N, ET AL. A COMPUTED TOMOGRAPHY STUDY OF CORONARY ACCESS AND CORONARY OBSTRUCTION AFTER REDO TRANSCATHETER AORTIC VALVE IMPLANTATION. EUROINTERVENTION. 2020 DEC 18;16(12):E1005-E1013. DOI: 10.4244/EIJ-D-20-00475. EARLIEST DATE OF PUBLISH USED FOR DATE OF EVENT. 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 FROM A LITERATURE ARTICLE REGARDING THE USE OF MULTI-DETECTOR COMPUTED TOMOGRAPHY TO INVESTIGATE THE POTENTIAL RISK OF IMPAIRED CORONARY ACCESS AND CORONARY OBSTRUCTION IF REDO TRANSCATHETER AORTIC VALVE IMPLANTATION (TAVI) IS REQUIRED. ALL DATA WAS RETROSPECTIVELY COLLECTED AND ANALYZED FROM THREE EUROPEAN CENTERS BETWEEN 2007 AND MAY 2018. OF THE 221 PATIENTS INCLUDED IN THE STUDY POPULATION (PREDOMINANTLY FEMALE, MEAN AGE 80.9 YEARS), 138 UNDERWENT INITIAL TAVI WITH THE MEDTRONIC COREVALVE. NO UNIQUE DEVICE IDENTIFIER NUMBERS WERE PROVIDED. AMONG ALL PATIENTS, ADVERSE EVENTS INCLUDED: REDO TAVI DUE TO VALVE MALPOSITION/LOW IMPLANT DEPTH (NINE CASES, INCLUDING ONE PATIENT INITIALLY TREATED WITH A 29 MM COREVALVE); VALVULOPLASTY (ONE CASE); AND LEAK CLOSURE (ONE CASE). COREVALVE 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
    1253205 COREVALVE TRANSCATHETER AORTIC VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV NPT MEDTRONIC HEART VALVES DIVISION CRS

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention