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	02/07/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This complaint was reopened in reference to (b)(4).Investigation: (description incoming product condition), we received the valve in the return kit.The valve was inserted in an unknown liquid.Summary: first, we performed a visual inspection of the system.Except for scratches, no significant deformations or damage of the valves were detected during the visual inspection.Next, we tested permeability, adjustability, and opening pressure of the valve, as well as the brake functionality and brake force.The brake function of the valve operates as expected.However, the braking force required was slightly outside the specified tolerances.Exerting too much pressure on the surface of the housing may impair the function.The valve could be tested as permeable even tough difficult.During the adjustment test the valve could be adjusted to any pressure level, both upward and downward.The first measurement of opening pressure of the valve has shown that the valve is outside the tolerance.A second test run showed an improvement.Based on our results, an under-drainage could be detected.The shunt assistant is operating within the specified tolerances in the vertical position.Finally, we have dismantled the valves.Inside both valves we have found slight build-up of substances (likely protein).Based on our investigation, we state that the valve shows a slower flow of liquid 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 christoph miethke gmbh & co.Kg.No further actions required.
Event or Problem Description
According to the complainant a progav had a malfunction postoperatively.The patient was originally implanted on (b)(6) 2016.The valve was explanted on (b)(6) 2017 and returned to the manufacturer for evaluation.Further details were not provided.Height: 164 cm.

• 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
• MDR Report Key: 12728837
• Report Number: 3004721439-2021-00704
• Device Sequence Number: 4499005
• Product Code: JXG
• UDI-Device Identifier: 04041906136970
• UDI-Public: 4041906136970
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K141687
• 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: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/01/2021

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: FX427T
• Device Catalogue Number: FX427T
• Device Lot Number: 20031361
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/17/2017
• Initial Report FDA Received Date: 11/01/2021
• 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
• Patient Age: 74 YR
• Patient Weight: 84