A facility reported that on (b)(6) 2021, a certas valve (ref.(b)(4)) was implanted in a (b)(6) year-old male patient due to internal occlusive post-inflammatory hydrocephalus.In the postoperative period there was an increase of the intracranial hypertension and the patient was experiencing headaches in the frontal region and vomiting.On (b)(6) 2021, x-ray computed tomography showed signs of an enlarged fourth ventricle, internal occlusive hydrocephalus, dislocation of the cerebellar tonsils into the foramen magnum.On (b)(6)2021 the patient underwent revision surgery: vp shunt revision, replacement of the programmable valve with ((b)(4)) with pressure level - setting 4.There was an improvement in patient's well-being after revision surgery.Cerebral symptoms regressed.
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The certas valve was returned for evaluation: failure analysis - the valve was visually inspected; the needle guard was raised as well as a needle hole in the needle chamber.The valve was leak tested; only leaked from the needle hole in the needle chamber.The valve passed the tests for programming, occlusion, reflux, siphon guard and pressure.The needle chamber was dismantled; the needle guard was bent, and glue traces were noted on the needle guard and the silicone base.The root cause for the issue reported by the customer is probably due to the raised needle guard this is due to wrong handling as noted in the ifu: do not fold or bend the valve, folding or bending might cause rupture of the silicone housing, needle guard disc dislodgement or occlusion of the fluid pathway, at the time of investigation no functional issues were noted with the valve.
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