BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RING 620R27 DURAN ANCORE ANNULOPLASTY 27

    MDR report key: 5887172 · Received August 18, 2016

    Report

    Report Number
    2025587-2016-01282
    Event Type
    Injury
    Date Received
    August 18, 2016
    Date of Event
    March 1, 2009
    Report Date
    July 20, 2016
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    KRH
    PMA / PMN Number
    K960356
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: YUNOKI J. J CARD SURG 2009;24:143-145. MITRAL VALVE STENOSIS CAUSED BY ABNORMAL PANNUS EXTENSION OVER THE PROSTHETIC RING AND LEAFLETS AFTER DURAN RING MITRAL ANNULOPLASTY 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.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION VIA LITERATURE OF A (B)(6) YEAR-OLD FEMALE PATIENT WITH FOR NON-RHEUMATIC MITRAL REGURGITATION (MR) ASSOCIATED WITH A RUPTURED POSTERIOR LEAFLET CHORDAE. SHE UNDERWENT A PROCEDURE WITH QUADRANGULAR RESECTION, RECONSTRUCTION OF THE POSTERIOR LEAFLET CHORDAE, AND IMPLANT OF A 27-MM MEDTRONIC DURAN RING. SUBSEQUENTLY, FIVE YEARS AND EIGHT MONTHS (AT THE AGE OF (B)(6) YEARS) AFTER THE INITIAL IMPLANT THE PATIENT PRESENTED WITH EXERTIONAL DYSPNEA. RADIOGRAPHY SHOWED MILD CARDIAC ENLARGEMENT. ELECTROCARDIOGRAM REVEALED SINUS RHYTHM WITH LEFT ATRIAL OVERLOAD. CARDIAC CATHETERIZATION SHOWED PULMONARY ARTERY PRESSURE OF 60/35. DURING A STERNOTOMY THE MITRAL RING AND BOTH LEAFLETS WERE FOUND COVERED BY PANNUS WHICH NARROWED THE MITRAL ORIFICE AND RESTRICTED THE LEAFLET MOBILITY. THE RING AND BOTH LEAFLETS WERE RESECTED. HISTOPATHOLOGICAL EXAMINATION SHOWED FOREIGN BODY GRANULOMA ASSOCIATED WITH GIANT CELLS AROUND THE EXCISED DURAN RING AND LEAFLET THICKENING TOGETHER WITH INFILTRATION OF INFLAMMATORY CELLS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    537011 RING 620R27 DURAN ANCORE ANNULOPLASTY 27 RING, ANNULOPLASTY KRH MEDTRONIC HEART VALVES DIVISION 620R27

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention