A physician reported a certas valve occlusion: the valve was implanted on a (b)(6) year-old female via v-p shunt on (b)(6) 2019 with an unknown initial setting to treat snph (secondary normal pressure hydrocephalus).On (b)(6) 2020, the patient presented with gait disorder and cerebral ventricular enlargement was observed in a ct image.Then valve occlusion was suspected by contrast study.Therefore, it was replaced with a new valve on (b)(6) 2020.
|
Unique device identifier (udi): (b)(4).The certas valve was returned for evaluation: failure analysis - the position of the cam when valve was received was at setting 4.The valve was visually inspected; no defects were noted.The catheter was irrigated, no occlusions noted.The valve was hydrated.The valve passed the test for programming, leaks, occlusion, 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 biological debris and protein buildup interfering with the valve mechanism at the time of investigation, no occlusion issues were noted.
|