ST. JUDE MEDICAL PUERTO RICO, INC. REGENT AORTIC MHV,FLEX C UFF,19MM; HEART-VALVE, MECHANICAL
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Model Number 19AGFN-756 |
Device Problems
Crack (1135); Noise, Audible (3273)
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Patient Problem
Death (1802)
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Event Date 08/25/2014 |
Event Type
Death
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Manufacturer Narrative
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The results of this investigation concluded a fracture went through the entire thickness of the orifice at the blend radius section.Both leaflets were fully mobile and no damage was found to the recessed pivot areas, or leaflets.There was no evidence of material defect in the carbon coating that may have caused or contributed to the orifice damage.Rather, the orifice damage was apparently caused by some external force applied to the orifice which overstressed the carbon material.There was no evidence found to suggest there was an intrinsic defect in the valve, as supported by the review of the device history record and the analysis performed.The cause of the reported event remains unknown.
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Event Description
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The patient underwent double valve replacement and an aortic annular enlargement.After implanting the mitral valve, this 19mm sjm regent valve was implanted in the aortic position.While attempting to rotate the valve, an audible "pop" was heard and a crack was observed on the valve orifice near the pivot guard.The valve was removed and replaced with another 19mm sjm regent valve.The patient expired due to lv failure on an unknown date.According to the physician, the patient was unstable for multiple reasons after undergoing surgery.
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Manufacturer Narrative
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(b)(4).
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