BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOSAIC AORTIC BIOPROSTHETIC HEART VALVE

    MDR report key: 1874456 · Received October 13, 2010

    Report

    Report Number
    2025587-2010-00124
    Event Type
    Injury
    Date Received
    October 13, 2010
    Date of Event
    September 13, 2010
    Report Date
    September 13, 2010
    Manufacturer
    MEDTRONIC HEART VALVES, INC.
    Product Code
    LWR
    PMA / PMN Number
    P990064
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): METHOD - DEVICE HISTORY REVIEWED. RESULTS - DEVICE HISTORY REVIEW FOUND THE PRODUCT MET SPECIFICATIONS WHEN RELEASED FOR DISTRIBUTION. CONCLUSION - CAUSE OF EVENT ATTRIBUTED TO OPERATIONAL TECHNIQUE. ANALYSIS: UPON RECEIPT AT MEDTRONIC'S QUALITY LABORATORY, ALL LEAFLETS WERE SLIGHTLY STIFF BUT FLEXIBLE. THE VALVE WAS DISTORTED; OVAL OR ALMOND-SHAPED. TWO TEARS AND ABRASIONS THROUGH THE FREE MARGIN AND LUNULA OF THE NON-CORONARY CUSP APPEARED TO BE DUE TO CONTACT WITH A LONG SUTURE TAIL. AN INDENTATION IN THE HOST TISSUE ALONG THE SIDE OF THE NON-CORONARY LEFT STENT POST SHOWED THE LOCATION OF A LONG SUTURE TAIL. A TINY ABRASION IN THE FREE MARGIN OF THE LEFT CUSP APPEARED TO HAVE ORIGINATED WITH A LONG SUTURE TAIL. REMNANTS OF GLISTENING OFF-WHITE PANNUS REMAINED ATTACHED TO THE SEWING RING ON THE OUTFLOW AND OUTFLOW RAIL ADJACENT TO THE NON-CORONARY STENT POST. A CREASE ALONG THE INFLOW MARGIN OF ATTACHMENT OF THE LEFT AND RIGHT CUSPS APPEARED TO BE ASSOCIATED WITH THE STENT DISTORTION. RADIOGRAPHY SHOWED NO EVIDENCE OF MINERALIZATION IN THE VALVE. CONCLUSION: THE DEVICE HISTORY RECORD WAS REVIEWED AND SHOWED THAT THIS PRODUCT MET ALL MANUFACTURING SPECIFICATION FOR PRODUCT RELEASED FOR DISTRIBUTION. NO ISSUES WERE IDENTIFIED THAT WOULD HAVE IMPACTED THIS EVENT. ANALYSIS CONCLUDED THAT THE POSSIBLE CAUSE OF THE PARAVALVULAR LEAK MAY HAVE BEEN DUE TO THE STENT DISTORTION AND THE TEARS WERE CAUSED BY A LONG SUTURE TAIL.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THAT THIS BIOPROSTHETIC VALVE, IMPLANTED 2.5 MONTHS, WAS EXPLANTED DUE TO PARAVALVULAR LEAK. THIS WAS THE FIRST MINIMALLY INVASIVE AORTIC VALVE REPLACEMENT PERFORMED BY THE SURGEON. A TEAR WAS ALSO IDENTIFIED ON THE LEADING EDGE OF ONE OF THE LEAFLETS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MOSAIC AORTIC BIOPROSTHETIC HEART VALVE LWR MEDTRONIC HEART VALVES, INC. 305 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention