PROGAV 2.0 SYSTEM WITH CONTROL RESERVOIR FX431T

[188548928] Manufacturing and quality control data - we have only received the product data, article number (b)(4) and serial number (b)(4). The product itself is not available for an investigation. Nevertheless, our traceability can prove that there were no deviations. The valve was manufactured by a qualified employee in december 2017. Deviations during assembly did not occur. The progav has a normal pressure range of 0 to 20 cmh2o. All parameters (opening pressure, reflux, adjustability and brake function) are inspected and signed during the manufacturing process. Investigation: description incoming product condition: no products received for investigation. Optical inspection : not applicable, because no products were available for investigation. Testing : not applicable, because no products were available for investigation. Result : an investigation was not possible because no product was sent for it. Please note that it is important to position the adjustment tool centrally over the valve. Please be aware that the steps for changing the pressure setting should not be more than 8 cmh2o per step. The rotor turns correctly. Please note that despite correct use of the setting tool, it may be difficult to adjust the valve as the skin swells in the first few days postoperatively. In the treatment of hydrocephalus with shunts, the following complications may arise: infections, blockages caused by protein and/or blood in the cerebrospinal fluid, over/under drainage or in very rare cases noise development. Violent shocks from the outside (accident, fall) may put the integrity of the shunt system at risk. Why the valve to adjusted itself does not explain us. This would require an examination of the product. Further actions: based on the current information, no further actions are required from our point of view.
Patient Sequence No: 1, Text Type: N, H10

[188548929] It was reported that there was an issue with the shunt system, via a complaint form and information from medwatch (b)(4). The patient was initially implanted with a progav valve on (b)(6) 2018, which had been set to a specific setting. Postoperatively, the setting changed and became lower. It was reset but changed a second time on the same day. This led to over-drainage of the ventricles and intracranial hypotension; the patient experienced cerebellar hemorrhage and "decline" in his exam. Emergency craniotomy was performed 2 days later for decompression. Clot evaluation and valve replacement occurred soon after. It was noted that the valve had reset on its own again prior to that revision. The patient remained intubated and was transferred to the intensive care unit (icu) after the surgery. Additional information was not provided, however, it has been requested.
Patient Sequence No: 1, Text Type: D, B5