1 of 2 reports.Other mfg report number: 3013886523-2021-00295.A physician reported that the certas valve was implanted to a (b)(6) year-old female patient via v-p shunt on (b)(6) 2021 with an unknown setting.On (b)(6) 2021, a shunt contrast was performed because the patient presented with disorientation and ventricular enlargement was confirmed.Obstruction was confirmed using a contrast medium, distribution was confirmed up to the inside of the valve, and there was a possibility of obstruction at the sg site and the distal catheter site.On (b)(6) 2021, the valve and bactiseal catheter (823073, serial (b)(4)) were revised, but not replaced.The physician tried to replace the shunt; however, it was found that the abdominal catheter was not placed properly.The same one was placed again.
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The certas valve (828814) was not returned for evaluation therefore, an evaluation of the device could not be performed.Lot number information has been provided; therefore, manufacturing records were reviewed and found no anomalies.The cause(s) of the difficulty reported by the customer could not be determined.If additional relevant information becomes available in the future, this complaint will be reopened, and the respective evaluation performed.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.
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