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

Model Number	FX427T
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	09/11/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the complainant a progav had pressure adjustment failure postoperatively.The valve was implanted on (b)(6) 2017.It was noted that the pressure value could not be adjusted.It was revised on (b)(6) 2017 and was returned to the manufacturer.Further details were not provided.
Additional Manufacturer Narrative
This complaint was reopened in reference to (b)(4).Investigation: (description incoming product condition) we received the valve in the returnkit; the valve was not inserted in liquid and was sent dry.Results: first we want to point out that we received the valve dry in the kit (without liquid).The investigation of a dry valve is not significant because dry deposits of liquor and blood can affect the product performance.In spite of this, we still decided to investigate the valve.In the visual inspection of the valve, we could not detect any apparent damage.It was possible to adjust the valve up and down again in steps of 5 cmh2o.To prove if the brake function is fully in place we carried out a brake function test.The investigation has shown that the brake function is present.Further we carried out a permeability test.The investigation has shown that the valve is permeable.As a final step, we carried out a computer controlled test.Here the valve was tested in the lying position with a pressure range of 5 cmh2o.At the test teh opening pressure at the reference flow level of 5 ml/h is measured 13,53 cmh2o.The valve was working outside the tolerance (accepted tolerance of 5 +/- 2 cmh2o).On the basis of our investigation results we have detected an under-drainage instead of the suspected over-drainage.We suspect that deposits inside the valve may have affected the product performance.We have investigated the shunt assistant as well.The visual inspection revealed that there were no deformations or other abnormalities.The shunt assistant was tested in the same way for permeability.The test results showed that the valve was not penetrable.Because it was not penetrable, the computer controlled test measurement was not possible.Given the fact that during the treatment with shunts the following complications may arise (as described in the literature): infections, blockages caused by protein and/or blood in the cerebrospinal fluid (csf), over/under drainage, or in very rare cases, noise development, we decided to dismantle the valves.Inside the progav we have found apparent deposits or substances of protein.None were found in the shunt assistant.Based on our investigation results, we suspect that the found deposits could have affected the shunt system.No further actions required.The problem encountered is one of the known, unchanging risks of hc therapy with shunt implants.
Event or Problem Description
According to the complainant a progav had pressure adjustment failure postoperatively.The valve was implanted on (b)(6) 2017.It was noted that the pressure value could not be adjusted.It was revised on (b)(6) 2017 and was returned to the manufacturer.Further details were not provided.
Additional Manufacturer Narrative
This complaint was reopened in reference to (b)(4).Investigation: (description incoming product condition) we received the valve in the returnkit; the valve was not inserted in liquid and was sent dry.Results: first we want to point out that we received the valve dry in the kit (without liquid).The investigation of a dry valve is not significant because dry deposits of liquor and blood can affect the product performance.In spite of this, we still decided to investigate the valve.In the visual inspection of the valve, we could not detect any apparent damage.It was possible to adjust the valve up and down again in steps of 5 cmh2o.To prove if the brake function is fully in place we carried out a brake function test.The investigation has shown that the brake function is present.Further we carried out a permeability test.The investigation has shown that the valve is permeable.As a final step, we carried out a computer controlled test.Here the valve was tested in the lying position with a pressure range of 5 cmh2o.At the test teh opening pressure at the reference flow level of 5 ml/h is measured 13,53 cmh2o.The valve was working outside the tolerance (accepted tolerance of 5 +/- 2 cmh2o).On the basis of our investigation results we have detected an under-drainage instead of the suspected over-drainage.We suspect that deposits inside the valve may have affected the product performance.We have investigated the shunt assistant as well.The visual inspection revealed that there were no deformations or other abnormalities.The shunt assistant was tested in the same way for permeability.The test results showed that the valve was not penetrable.Because it was not penetrable, the computer controlled test measurement was not possible.Given the fact that during the treatment with shunts the following complications may arise (as described in the literature): infections, blockages caused by protein and/or blood in the cerebrospinal fluid (csf), over/under drainage, or in very rare cases, noise development, we decided to dismantle the valves.Inside the progav we have found apparent deposits or substances of protein.None were found in the shunt assistant.Based on our investigation results, we suspect that the found deposits could have affected the shunt system.No further actions required.The problem encountered is one of the known, unchanging risks of hc therapy with shunt implants.

• Brand Name: PROGAV 2.0 SYS W/SA20 A.SPRUNG RESERVOIR
• Common Device Name: HYDROCEPHALUS MANAGEMENT
• Manufacturer (Section D): CHRISTOPH MIETHKE GMBH & CO KG; ulanenweg 2; potsdam, 14469 ; GM 14469
• Manufacturer (Section G): CHRISTOPH MIETHKE GMBH & CO KG; ulanenweg 2; potsdam, 14469 ; GM 14469
• Manufacturer Contact: joerg knebel ; ulanenweg 2; potsdam, 14469 ; GM 14469
• MDR Report Key: 13047603
• Report Number: 3004721439-2021-00831
• Device Sequence Number: 1854939
• Product Code: JXG
• UDI-Device Identifier: 04041906136970
• UDI-Public: 4041906136970
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K141687
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2017
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/20/2021

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: 06/30/2021
• Device Model Number: FX427T
• Device Catalogue Number: FX427T
• Device Lot Number: 20031733
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/26/2017
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/12/2017
• Initial Report FDA Received Date: 12/20/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/02/2016
• 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 Sex: Unknown