(b)(4).Upon completion of the investigation, it was noted that the valve was visually inspected it was noted that the stator was dislodged.Therefore; the cam position/pressure could not be determined.The valve was hydrated for 24 hours.The valve was flushed, the valve passed the test no occlusion was noted.The valve was leak tested, no leaks were noted.The valve was reflux tested, the valve passed the test.The valve was dried.The valve was dismantled and was examined under microscope at appropriate magnification: a scratch mark was noted in the valve casing.This is probably due to the valve receiving some form of impact.The cam magnets were controlled.The magnets passed.Review of the history device records confirmed the valve product code 82-3110, with lot ckcbp8, conformed to the specifications when released to stock on the 10th march 2009.The stator dislodgement of chpv was investigated.The investigation concluded that several factors may contribute to the stator dislodgement.Trauma to the valve, whether it occurs while implanted or at explant, was the root cause of stator dislodgement.This issue will continued to be monitored through monthly complaint trending and the post market surveillance process.Based on the results of this investigation, no further action is required.Trends will be monitored for this and similar complaints.At the present time this complaint is closed.
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