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Model Number 31M-101 |
Device Problem
Gradient Increase (1270)
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Patient Problems
Right Ventricular Dysfunction (2054); Thrombus (2101); Regurgitation, Valvular (2335)
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Event Date 12/02/2014 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).The results of this investigation concluded thrombus formation in the recessed pivot area, and both leaflets opened and closed with difficulty with incomplete closure of one of the leaflets.Special stains were negative for organisms, and no acute inflammation or significant calcifications were present.There was no evidence found to suggest the cause of the thrombus formation was due to an intrinsic defect in the valve, as supported by review of the valve's device history record and the analysis performed.The cause of the fibrin and tears remains unknown.
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Event Description
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A 2d echocardiogram demonstrated a mechanical mitral valve with restricted opening, mild paravalvular regurgitation, elevated gradients, and significant right ventricular dysfunction.The mechanical valve was explanted and replaced with a smaller 27 mm sjm epic tissue valve.At the time of explant, thrombus was observed on the valve.The patient was reported to be stable postoperatively.
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Manufacturer Narrative
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(b)(4).
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Search Alerts/Recalls
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