MAUDE Adverse Event Report: PROGAV SYS W/SA 25 A.CONTROL RESERVOIR; HYDROCEPHALUS MANAGEMENT

Model Number	FV435T
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	05/05/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This complaint was reopened in reference to (b)(4).Manufacturing site evaluation: manufacturing and quality control data: the progav® was manufactured by a qualified employee in march 2012.Deviations during assembly did not occur.The valve was sterilized by miethke and released for shipment after final inspection.The progav® has a normal pressure range of 0 to 20 cmh2o.The valve was inspected as article fv435t.All parameters have been inspected and approved during the manufacturing process.All parameters have been assessed as meeting specification.Device examination: the valve was received submersed in an unidentified liquid in the provided returnkit.Visual inspection: no significant deformations or damage to the valve were detected during the visual inspection.However, a measurement of the plane parallelism revealed that the valve was outside the permitted tolerance.Additional the progav housing was measured which confirmed the presence of a deformation.Permeability test: a permeability test has shown that the valve was permeable.Adjustment test: the progav® was tested and was adjustable to all specified pressures.Braking force and brake function test: the brake functionality test has shown that the brake function operated as expected.However, the braking force required was not within the given specification.Computer controlled test: to investigate the claim of over-drainage, the opening pressure was measured using a miethke computer controlled testing apparatus which simulates a cerebrospinal fluid flow.The results showed that the valve was not operating within the accepted tolerance in the horizontal body position.Contrary to the assumed over-drainage, the valve tends to under-drain.A second measurement showed an improvement of the values.Result: first, a visual inspection of the progav®.No significant deformations or damage to the valve were detected during the visual inspection.However, a measurement of the plane parallelism revealed that the valve was outside the permitted tolerance.Next, the permeability, adjustability, as well as the brake functionally and brake force, of the valve were tested.The valve was shown to be permeable and adjustable to all specified pressures.The brake operated as expected, however, the braking force was outside of tolerance.The first measurement of the opening pressure revealed that the valve tended to under-drain, contrary to the suspected over-drainage.Throughout the second measurement an improvement of the valves was observed.Presumably further testing would lead to a continued improvement of the values because any deposits inside the valve would be flushed out.Finally, the valve was dismantled.A build-up of a substance (likely protein) was observed inside the valve.Based on the investigation, deposits were confirmed to be present inside the valve which may have led to the reported malfunction.As described in scientific literature, the problem encountered is one of the known, inevitable risks of hydrocephalus (hc)-therapy by shunt implants.Manufacturing defects at the time of release have been excluded.The valve met all specifications of the final inspection when released from christoph miethke gmbh & co.Kg.No further regulatory actions are required.
Event or Problem Description
It was reported miethke that a progav sys w/sa 25 a.Control reservoir (part # fv435t) was implanted during a procedure performed on (b)(6) 2013.According to the complainant, the valve was suspected of operating in over-drainage.The patient underwent a revision procedure on (b)(6) 2017.The complaint device was returned to the manufacturer for evaluation.No patient complications were reported as a result of the revision procedure.Age: (b)(6), weight: (b)(6) kilograms (kg), height: 120 centimeters (cm), gender: unknown.

• Brand Name: PROGAV SYS W/SA 25 A.CONTROL RESERVOIR
• Common Device Name: HYDROCEPHALUS MANAGEMENT
• MDR Report Key: 12746977
• Report Number: 3004721439-2021-00737
• Device Sequence Number: 4480948
• Product Code: JXG
• UDI-Device Identifier: 04041906132477
• UDI-Public: 4041906132477
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K103003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2017
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: FV435T
• Device Catalogue Number: FV435T
• Device Lot Number: 20016284
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/15/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/17/2017
• Initial Report FDA Received Date: 11/03/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/19/2012
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 5 YR
• Patient Weight: 23