BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC SURGICAL TISSUE VALVE

    MDR report key: 12298087 · Received August 9, 2021

    Report

    Report Number
    2025587-2021-02498
    Event Type
    Injury
    Date Received
    August 9, 2021
    Date of Event
    June 13, 2018
    Report Date
    August 9, 2021
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    DYE
    PMA / PMN Number
    P870078
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: SHAH VN, ET AL. TRANSCATHETER AND MINISTERNOTOMY AORTIC VALVE REPLACEMENT AFTER BIOPROSTHETIC VALVE FAILURE. J CARD SURG. 2021 FEB;36(2):493-500. DOI: 10.1111/JOCS.15225. EPUB 2020 DEC 6. PRESENTED AT THE ORAL SESSION OF THE EIGHTEENTH ANNUAL SCIENTIFIC MEETING OF THE INTERNATIONAL SOCIETY FOR MINIMALLY INVASIVE CARDIOTHORACIC SURGERY, JUNE 13-16, 2018, VANCOUVER, CANADA. EARLIEST DATE OF PRESENTATION USED FOR DATE OF EVENT. MEDTRONIC PRODUCTS REFERENCED: FREESTYLE (PMA# P970031, PRODUCT CODE LWR), HANCOCK (PMA# P870078, PRODUCT CODE DYE), MOSAIC (PMA# P990064, PRODUCT CODE DYE), 3F (PMA# P060025, PRODUCT CODE LWR). EARLIEST APPROVED PRODUCT USED FOR PRODUCT CODE AND PMA#. 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 PATIENT OUTCOMES FOLLOWING TRANSCATHETER VALVE-IN-VALVE IMPLANTATION (TVIV) AND MINIMALLY INVASIVE REOPERATIVE AORTIC VALVE REPLACEMENT (MIRAVR) FOR BIOPROSTHETIC VALVE DEGENERATION. ALL DATA WAS RETROSPECTIVELY COLLECTED FROM A SINGLE CENTER BETWEEN MARCH 2009 AND OCTOBER 2018. THE STUDY POPULATION INCLUDED 68 PATIENTS (TVIV = 41; MIRAVR = 27) AND WAS PREDOMINANTLY MALE WITH A MEDIAN AGE OF 69 YEARS. OF THESE PATIENTS, 19 WERE PREVIOUSLY IMPLANTED WITH MEDTRONIC SURGICAL AORTIC VALVES: FREESTYLE (12), HANCOCK (2), MOSAIC (3), AND 3F (2). OF THE 41 PATIENTS WHO UNDERWENT TVIV, 10 WERE IMPLANTED WITH MEDTRONIC TRANSCATHETER AORTIC VALVES: COREVALVE (3), EVOLUT R (6), AND EVOLUT PRO (1). NO UNIQUE DEVICE IDENTIFIER NUMBERS WERE PROVIDED. AMONG ALL PATIENTS, ONE IN-HOSPITAL DEATH OCCURRED, AND ANOTHER DEATH OCCURRED WITHIN THIRTY DAYS OF THE PROCEDURE. THE DEATHS WERE NOT ATTRIBUTED TO MEDTRONIC PRODUCT. ADVERSE EVENTS ASSOCIATED WITH MEDTRONIC SURGICAL AORTIC VALVES: TVIV (MEAN 9.6 YEARS AFTER SURGICAL VALVE IMPLANT) OR MIRAVR (MEAN 7.9 YEARS AFTER SURGICAL VALVE IMPLANT) FOR BIOPROSTHETIC VALVE DEGENERATION (AORTIC INSUFFICIENCY, AORTIC STENOSIS, OR MIXED INSUFFICIENCY/STENOSIS), HEART FAILURE, AND ELEVATED GRADIENTS. ADVERSE EVENTS THAT MAY HAVE BEEN ASSOCIATED WITH MEDTRONIC TRANSCATHETER AORTIC VALVES: PERMANENT PACEMAKER IMPLANTATION; CORONARY OBSTRUCTION; NEED FOR BLOOD TRANSFUSION; MILD TO MODERATE PARAVALVULAR LEAK; ATRIAL FIBRILLATION; AND HOSPITAL READMISSION WITHIN THIRTY DAYS POST-IMPLANT. NO ADDITIONAL ADVERSE PATIENT EFFECTS OR PRODUCT PERFORMANCE ISSUES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1193577 MEDTRONIC SURGICAL TISSUE VALVE REPLACEMENT HEART-VALVE DYE MEDTRONIC HEART VALVES DIVISION MDT-TISSUE VALVE

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization| R