BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THV 1000-27 3F AORTIC BIO 27MM

    MDR report key: 2827718 · Received November 9, 2012

    Report

    Report Number
    2031780-2012-00009
    Event Type
    Injury
    Date Received
    November 9, 2012
    Report Date
    March 27, 2014
    Manufacturer
    MEDTRONIC ATS 3F THERAPEUTICS
    Product Code
    LWR
    PMA / PMN Number
    P060025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THIS DEVICE REMAINS IMPLANTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM THE ARTICLE'S AUTHOR. A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED. (B)(6). (B)(4).

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THROUGH AN OCTOBER 2012 ARTICLE IN CIRCULATION: CARDIOVASCULAR INTERVENTIONS (DOI: 10.1161/CIRCINTERV ENTIONS.112.972331) THAT AN ATS 3F AORTIC BIOPROSTHESIS IMPLANTED 16 MONTHS EXHIBITED AORTIC STENOSIS AND AORTIC REGURGITATION. THE PATIENT SUBSEQUENTLY RECEIVED A VALVE-IN-VALVE IMPLANT OF ANOTHER MODEL TRANSCATHETER BIOPROSTHETIC VALVE THAT SUCCESSFULLY RESOLVED THE REPORTED CONDITIONS. THERE WERE NO ADVERSE PATIENT EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THV 1000-27 3F AORTIC BIO 27MM HEART-VALVE, NON-ALLOGRAFT TISSUE LWR MEDTRONIC ATS 3F THERAPEUTICS 1000-27

    Patients

    Seq Age Sex Outcome Treatment
    1 00065 YR Required Intervention