BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOSAIC AORTIC BIOPROSTETIC HEART VAVLE

    MDR report key: 2202492 · Received August 5, 2011

    Report

    Report Number
    2025587-2011-00101
    Event Type
    Injury
    Date Received
    August 5, 2011
    Date of Event
    July 6, 2011
    Report Date
    July 6, 2011
    Manufacturer
    MEDTRONIC HEART VALVES, INC.
    Product Code
    LWR
    PMA / PMN Number
    P990064
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL METHOD: DEVICE HISTORY REVIEWED. RESULTS CODE: OTHER = DEVICE HISTORY REVIEW FOUND THE PRODUCT MET SPECIFICATIONS WHEN RELEASED FOR DISTRIBUTION. CONCLUSION: CAUSE OF EVENT DETERMINED TO BE RELATED TO PT CONDITION AND/OR IMPLANT TECHNIQUE. ANALYSIS: UPON RECEIPT AT MEDTRONIC'S QUALITY LABORATORY, ALL LEAFLETS WERE SLIGHTLY STIFF BUT FLEXIBLE EXCEPT WHERE HOST TISSUE EXTENDED ON THE INFLOW. THIS FINDING IS EXPECTED SINCE THE VALVE WENT THROUGH DECONTAMINATION PROCESS THAT INCLUDES A HIGH CONCENTRATION OF A TISSUE FIXATION AND ALONG WITH BLOOD CONTACT, ARE BOTH KNOWN TO CAUSE STIFFNESS OF THE TISSUE. A LARGE TEAR AND ABRASIONS ON THE LEFT CUSP THROUGH THE FREE MARGIN AND LUNULA WERE NOTED, DUE TO A LONG SUTURE TAIL AND/OR CONTACT WITH THE BIAS CLOTH. A HOLE IN THE SEWING RING AND HOST TISSUE WAS INLINE WITH THE TEAR. A TEAR IN THE NON-CORONARY CUSP ADJACENT TO THE NON-CORONARY LEFT STENT POST WAS NOTED, DUE TO CONTACT WITH THE BIAS CLOTH. GLISTENING OFF-WHITE PANNUS REMAINED ATTACHED TO THE SEWING RING ADJACENT TO THE NON-CORONARY AND LEFT CUSPS, EXTENDING ALONG THE INFLOW MARGIN OF ATTACHMENT OF ALL CUSPS, INTO ALL INFERIOR COAPTIVE AREAS AND 1 TO 2 MM ONTO ALL CUSPS SLIGHTLY REDUCING THE INFLOW ORIFICE AREA. RADIOGRAPHY SHOWED NO EVIDENCE OF MINERALIZATION IN THE VALVE AND/OR HOST TISSUE. CONCLUSION: THE DEVICE HISTORY RECORD WAS REVIEWED AND SHOWED THAT THIS VALVE 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. THIS FINDING IS GENERALLY CONSIDERED A PT RELATED CONDITION. ADDITIONALLY, THE TEAR IN THE LEAFLET WAS CAUSED BY A LONG SUTURE TAIL AND/OR BIAS WEAR, WHICH IS RELATED TO IMPLANT TECHNIQUE.

    Description of Event or Problem · 1

    MEDTRONIC REC'D INFO THAT THIS BIOPROSTHETIC VALVE WAS EXPLAINED AFTER 9 MONTHS IMPLANT DURATION, DUE TO A TORN LEAFLET. NO ADVERSE PT EFFECTS HAVE BEEN REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention