MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG PROGAV 2.0 SYS W/SA20 A.CONTROL RESERV.; HYDROCEPHALUS MANAGEMENT

Model Number	FX434T
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	10/08/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation: visual inspection: no significant deformations or damage of the valves were detected during the visual inspection.Visible deposits in the control reservoir.Permeability test: a permeability test has shown that both valves are permeable.Adjustment test: the progav (b)(4) valve was tested, and is not adjustable throughout the normal range.The valve is only adjustable from 0 to 6 cmh2o.Braking force and brake function test: the brake functionality test has shown that the brake function is operational, however the braking force cannot be measured due to the non-adjustability of the valve.Results: first, we performed a visual inspection of the progav (b)(4) shunt system.No significant deformations, or damage of the valves were detected during the visual inspection.In the control reservoir are visible deposits detected.Next, we tested the permeability.Both valves were shown to be permeable.Additionally, we tested the adjustability as well as the brake functionality and break force of the progav (b)(4).The valve was not adjustable to all settings.The brake functionality was fully operational, however due to the inability of the valve to set all pressure ranges, it was not possible to measure the brake force.Finally, we have dismantled the valves.Inside both valves we have found build-up of substances (likely protein).Based on our investigation, we confirm that the progav 2.0 was not completely adjustable at the time of our investigation.This is likely due to the deposits observed inside the valves.As described in scientific literature, the problem encountered is one of the known, inevitable risks of hc-therapy by shunt implants.We can exclude a defect at the time of release.The shunt system met all specifications of the final inspection when released from (b)(6) gmbh & co.Kg.No further regulatory actions are required from our point of view.
Event or Problem Description
It was reported that there was a problem with a progav (b)(4) shunt system.The surgeon has reported that the valve is non-adjustable.Age: unknown; weight: unknown; height: unknown; gender: unknown; date of implantation: (b)(6) 2018.Date of removal: (b)(6) 2020.

• Brand Name: PROGAV 2.0 SYS W/SA20 A.CONTROL RESERV.
• Common Device Name: HYDROCEPHALUS MANAGEMENT
• Manufacturer (Section D): CHRISTOPH MIETHKE GMBH & CO KG; ulanenweg 2; potsdam, 14469 ; GM 14469
• MDR Report Key: 10822709
• Report Number: 3004721439-2020-00226
• Device Sequence Number: 3570354
• Product Code: JXG
• UDI-Device Identifier: 04041906137328
• UDI-Public: 04041906137328
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K161853
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/10/2020

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: 04/18/2023
• Device Model Number: FX434T
• Device Catalogue Number: FX434T
• Device Lot Number: 20037632
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/15/2020
• Initial Report FDA Received Date: 11/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention