This is 4 of 5 reports: background: a (b)(6) year-old male had a valve implanted (non-integra) on an unknown date.The valve was revised due to increased ventricle size on ct and fractured shunt showed on x-ray.At procedure, the old shunt was disconnected, a temporary catheter was connected due to catheter fracture and valve was confirmed as blocked with no csf egress.On (b)(6) 2020, a certas right angled valve was implanted (ref 828824 lot 4436813).On (b)(6) 2020 (1st revision), the certas valve (ref 828824 lot 4436813) was found to be blocked and was removed.The valve was not replaced with another valve: a rickham reservoir (ref 821623 lot 3711879) was inserted to allow access for csf testing and icp monitoring.A procedure for endoscopic third ventriculostomy was performed.On (b)(6) 2020, the patient had a surgery to insert a new certas valve (ref 828824 lot 4936170) and bactiseal ventricular catheter (ref 823073 lot 440595) and bactiseal ventricular and peritoneal catheter kit (ref 823072 lot# 4407195) were also inserted.On (b)(6) 2020, (2nd revision) the certas valve (ref 828824 lot 4936170) was found to be blocked.A ventriculoperitoneal (vp) shunt revision was performed and the valve was replaced with a new certas valve (ref 828824 lot 4837586) with setting of 4.On (b)(6) 2020, (3rd revision) the certas valve (ref 828824 lot 4837586) that was implanted on november 16, 2020 with a setting of 4 was found to be blocked.A new certas valve (ref 828824 lot 4123593) was placed with a setting of 3.On (b)(6) 2020, (4th revision) the certas valve that was implanted on (b)(6) 2020 (ref 828824 lot 4123593) appears blocked and the abdominal catheter was not flowing.The valve was revised with hakim valve and the valve was set at 90mmh.Also, the catheter kit implanted on november 11 (ref 823072 lot 4407195) was not flowing and was replaced with bactiseal ventricular and peritoneal catheter kit 823072 lot# 4451774.Each time the patient has a valve revision, he had an initial improvement of symptoms for a couple of days after insertion.Other mfg report no.: 3013886523-2020-00250 - second revision.3013886523-2020-00249 - third revision.3013886523-2020-00247 - fourth revision - product 1 (valve).3013886523-2020-00248 - fourth revision - product 2 (catheter kit).
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Unique device identifier (udi) : (b)(4).The valve was not returned for evaluation (as per customer, product not available) 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.The possible root cause for ¿valve was found to be blocked and was removed¿ could be due to biological debris and protein build up that may cause an occlusion.
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