BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NA

    MDR report key: 7161068 · Received January 3, 2018

    Report

    Report Number
    2025587-2018-00031
    Event Type
    Injury
    Date Received
    January 3, 2018
    Date of Event
    September 30, 2017
    Report Date
    January 3, 2018
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    DYE
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: HAJI ZEINALI AM, ABBASI K, SAHEB JAM M, YAZDANI S, MORTAZAVI SH. TRANSCATHETER HEART VALVE IN VALVE IMPLANTATION WITH EDWARDS SAPIEN BIOPROSTHETIC VALVE FOR DIFFERENT DEGENERATED BIOPROSTHETIC VALVE POSITIONS (FIRST IRANIAN VIV REPORT WITH MID-TERM FOLLOW UP). J CARDIOVASC THORAC RES 2017;9(3):152-157. DOI: 10.15171/JCVTR.2017.26 EARLIEST DATE OF E-PUBLISH/PUBLISH USED FOR EVENT DATE. NO UNIQUE DEVICE IDENTIFIER (SERIAL/LOT) NUMBERS WERE PROVIDED; WITHOUT THIS INFORMATION, IT CANNOT BE DETERMINED WHETHER THIS EVENT HAS BEEN PREVIOUSLY REPORTED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION VIA LITERATURE REVIEW REGARDING OUTCOMES AFTER THE IMPLANT OF A NON MEDTRONIC BALLOON EXPANDABLE TRANSCATHETER AORTIC VALVE IMPLANTED VALVE-IN-VALVE INTO FAILED SURGICAL VALVES. ALL DATA WERE COLLECTED FROM A SINGLE CENTER BETWEEN 2015 AND 2016. THE STUDY POPULATION INCLUDED 5 PATIENTS, 3 OF WHICH HAD PREVIOUSLY BEEN IMPLANTED WITH A MEDTRONIC DEVICE. SERIAL NUMBERS WERE NOT PROVIDED. MEDTRONIC RECEIVED INFORMATION THAT (B)(6) MALE PATIENT HAD BEEN IMPLANTED WITH A 25MM PULMONARY VALVE. SEVEN YEARS POST IMPLANT, THE VALVE WAS REPLACED IN A VALVE-IN-VALVE PROCEDURE DUE TO PULMONARY INSUFFICIENCY AND STENOSIS. NO ADDITIONAL ADVERSE PATIENT EFFECTS OR PRODUCT PERFORMANCE ISSUES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    3448 NA DYE MEDTRONIC HEART VALVES DIVISION SH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Required Intervention