BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOSAIC MITRAL BIOPROSTHETIC HEART VALVE

    MDR report key: 1833837 · Received September 9, 2010

    Report

    Report Number
    2025587-2010-00104
    Event Type
    Injury
    Date Received
    September 9, 2010
    Date of Event
    August 6, 2010
    Report Date
    August 12, 2010
    Manufacturer
    MEDTRONIC HEART VALVES, INC.
    Product Code
    LWR
    PMA / PMN Number
    P990064
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): EVAL RESULTS: DEVICE HISTORY REVIEW FOUND THE PRODUCT MET SPECIFICATIONS WHEN RELEASED FOR DISTRIBUTION. CONCLUSION: CAUSE OF EVENT ATTRIBUTED TO PT CONDITION. ANALYSIS: UPON RECEIPT AT MEDTRONIC'S QUALITY LABORATORY, A LARGE TEAR IN THE RIGHT CUSP ALONG THE MARGIN OF ATTACHMENT APPEARED TO BE ASSOCIATED WITH HOST TISSUE INFILTRATION THAT MAY HAVE ORIGINATED WITH A SLIGHT PERFORATION AT IMPLANT. SEVERAL COLLAGEN BANDS WERE NOTED ON THE OUTFLOW OF ALL CUSPS. A LARGE COLLAGEN BAND IN THE BELLY OF THE RIGHT CUSP WAS THICKENED DUE TO HOST TISSUE INFILTRATION. THE ELASTIC SPACE TISSUE AND SMALLER COLLAGEN BANDS ALONG THE OUTFLOW MARGIN OF ATTACHMENT OF THE RIGHT CUSP WERE SLIGHTLY DISCOLORED SHOWING EVIDENCE OF HOST TISSUE INFILTRATION. A SMALL PERFORATION WAS NOTED IN THE RIGHT CUSP ALONG THE INFLOW MARGIN OF ATTACHMENT ADJACENT TO THE LEFT RIGHT INFERIOR COAPTIVE AREA. REMNANTS OF PANNUS REMAINED ATTACHED TO THE INFLOW MARGIN OF ATTACHMENT OF ALL CUSPS INTO THE RIGHT NON-CORONARY INFERIOR COAPTIVE AREA. PANNUS ON THE OUTFLOW RAILS OF THE RIGHT AND NON-CORONARY CUSPS EXTENDED OVER TO THE OUTFLOW MARGIN OF ATTACHMENT. HOST TISSUE INFILTRATED THE RIGHT CUSP FROM THE MARGIN OF ATTACHMENT TO THE BELLY. RADIOGRAPHY SHOWED NO EVIDENCE OF MINERALIZATION IN THE VALVE AND/OR HOST TISSUE. CONCLUSION: THE DEVICE HISTORY RECORD WAS REVIEWED AND SHOWED THAT THIS PRODUCT MET ALL MFG SPECIFICATION FOR PRODUCT RELEASED FOR DISTRIBUTION. NO ISSUES WERE IDENTIFIED THAT WOULD HAVE IMPACTED THIS EVENT. REDUCED PERFORMANCE OF THE VALVE IS ATTRIBUTED TO HOST TISSUE OVERGROWTH. THERE FINDINGS ARE GENERALLY CONSIDERED A PT RELATED CONDITION.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFO THAT THIS BIOPROSTHETIC VALUE, IMPLANTED 3 YEARS, WAS EXPLANTED DUE TO MITRAL REGURGITATION. THERE WERE NO ADVERSE PT EFFECTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MOSAIC MITRAL BIOPROSTHETIC HEART VALVE LWR MEDTRONIC HEART VALVES, INC. 310 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention