MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG PROGAV 2.0 SYS W/SA15 A.SPRUNG RESERVOIR; HYDROCEPHALUS MANAGEMENT

Model Number	FX426T
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Hydrocephalus (3272)
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the complainant a progav was blocked postoperatively.The patient was implanted on (b)(6) 2015.Once the product was implanted, pressure could not be adjusted.However, the product was remained since the patient condition was good.The surgery for brain tumor had been done twice since the primary surgery without valve failure.However this time, the revision surgery was needed due to underdrainage.Therefore, the valve investigation included adjustment failure was requested.The valve was explanted on (b)(6) returned to the manufacturer for evaluation.Further details were not provided.Height: 172 cm.
Additional Manufacturer Narrative
This complaint was reopened in reference to (b)(4).Investigation ( description incoming product condition) we received the progav 2.0 valve under use of the returnkit.The valve was insert in liquid.The progav 2.0 was set to pressure range 5 cmh2o at the time of delivery.Result: in the visual inspection of the valve we could, scratch but has noapparent deformations or other abnormalities determine.It was possible to adjust the valve up and down again in steps of 5 cmh2o.To proof if the brake function is full in place we carried out a brake function test.The investigation has shown that the brake function is present.The braking force lies within the accepted tolerance.In the further course of the investigation, we tested the valve to permeability.The investigation results that the valve is permeable.Given the fact that during the treatment with shunts the following complications may arise: infections, blockages caused by protein and/or blood in the cerebrospinal fluid, over/under drainage, we decided to dismantle the valve.Inside the valve we found slight deposits of protein, perhaps the deposits inside the valve could have influenced the function in the past.A further explanation for non-adjustability could also be that the implantation site was chosen unfavorably or the skin over the valve was too thick.In this case, there is the possibility that the valve can no longer be adjusted.But at the time of delivery, there is no fault with this progav 2.0 valve.No further actions required.

• Brand Name: PROGAV 2.0 SYS W/SA15 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: 12892808
• Report Number: 3004721439-2021-00758
• Device Sequence Number: 1491887
• Product Code: JXG
• UDI-Device Identifier: 04041906136963
• UDI-Public: 4041906136963
• 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 Implanted Year: 2015
• Device Explanted Year: 2016
• 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): 11/30/2021

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: 06/30/2020
• Device Model Number: FX426T
• Device Catalogue Number: FX426T
• Device Lot Number: 20028164
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2017
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/02/2017
• Initial Report FDA Received Date: 11/30/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/13/2015
• 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: 65 YR
• Patient Sex: Male
• Patient Weight: 69 KG