MAUDE Adverse Event Report: PROGAV VALVE; HYDROCEPHALUS MANAGEMENT

Model Number	FV410T
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	05/17/2017
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 valve was manufactured by a qualified employee in february 2016.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 cmh20.The valve was inspected as article fv410t.All parameters of the valve have been inspected and approved during the manufacturing process.All parameters have been assessed as meeting specification.Device examination: the progav® valve was returned submersed in an unidentified liquid in the provided returnkit.Visual inspection: scratches and a significant deformation of the outer housing was detected during the visual inspection.A measurement of the plane parallelism confirmed the deformation.Permeability test: a permeability test has shown that the valve had a blockage.Adjustment test: the valve was tested and was not able to be adjusted throughout the normal range.Braking force and brake function test: the brake functionality test has shown that the brake function was not operational.The rotor no longer performed as intended.Computer controlled test: a computer controlled test was not able to be performed because the valve was not permeable.Result: first, a visual inspection of the valve was performed.Scratches and a significant deformation of the outer housing was detected during the visual inspection.A measurement of the plane parallelism confirmed the deformation.Next, the permeability, adjustability, as well as the brake functionally and brake force, of the valve were tested.The valve was neither permeable or adjustable.The brake was defective so the brake force and brake functionality tests were not able to be performed.Additionally, since the valve had a blockage, an investigation of the suspected over-drainage was not possible.Finally, the valve was dismantled.A build-up of a substance (likely protein) was observed inside the valve.Based on the investigation, the claim of the valve not operating as intended was able to be substantiated.It is possible that the deposits observed inside the valve 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.The cause of the deformation of the progav valve and the resultant defect of the rotor could not be determined.Manufacturing defects at the time of release have been excluded.The valve met all specifications of the final inspection when released from christoph miethke (b)(4).No further regulatory actions are required.
Event or Problem Description
It was reported to miethke that a progav valve (part # fv410t) was implanted during a procedure performed on (b)(6) 2016.According to the complainant, the valve was suspected of operating in over-drainage and a mechanism defect was observed.The patient underwent a revision procedure on an (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.

• Brand Name: PROGAV VALVE
• Common Device Name: HYDROCEPHALUS MANAGEMENT
• MDR Report Key: 12746508
• Report Number: 3004721439-2021-00743
• Device Sequence Number: 19953452
• Product Code: JXG
• UDI-Device Identifier: 04041906132071
• UDI-Public: 4041906132071
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• PMA/510(K) Number: K103003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• 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 Expiration Date: 12/31/2020
• Device Model Number: FV410T
• Device Catalogue Number: FV410T
• Device Lot Number: 20029340
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/24/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/31/2017
• Initial Report FDA Received Date: 11/03/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/17/2016
• 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: 37 YR
• Patient Weight: 19