A physician reported a certas valve was implanted in a (b)(6) year-old patient via unknown shunt about a year ago with an unknown setting.On (b)(6) 2021, obstruction was suspected and patient symptoms (unknown symptoms) worsened, therefore, the valve was removed and replaced to a new one on (b)(6) 2021.
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The certas valve was returned for evaluation.Failure analysis: the valve was visually inspected; no defects noted.The valve was hydrated.The valve passed the test for programming, occlusion, leaks, reflux, siphon guard and pressure.No root cause could be determined as the technician could not confirm any problem with the valve at the time of investigation.The possible root cause for the issue reported by the customer could be due to biological debris and protein build up interfering with the valve mechanism, at the time of investigation the no occlusion issues were noted with the valve.At present, we consider this complaint to be closed.
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