MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO. KG PROGAV 2.0 SYS M.SA25 U.SPRUNG RESERVOIR; HYDROCEPHALUS MANAGEMENT

Model Number	FX428T
Medical Device Problem Codes	Mechanical Problem (1384); Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	12/14/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The investigation is still pending.When additional informations are provided and the investigation is completed, a follow up will be provided in a supplemental report.
Event or Problem Description
It was reported that there was a problem with a progav 2.0 shuntsystem.The surgeon suspected an underdrainage and adjustment issues.Patient informations: age: (b)(6).Height: 170 cm.Weight: (b)(6).Gender: female.Implantation: (b)(6) 2018.Removal: (b)(6) 2020.
Additional Manufacturer Narrative
Investigation: visual inspection: some particles in the liquid and small deposits in the inlet spout, but no significant deformations or damage of the valves were detected during the visual inspection.Permeability test: a permeability test has shown that both valves are permeable.Adjustment test: the progav 2.0 was tested and is adjustable to all specified pressures.Braking force and brake function test: the brake functionality test has shown that the brake function is fully operational and the braking force is within the given tolerances.Computer controlled test: to investigate the clinical claim of underdrainage, the opening pressure is measured using a miethke computer controlled testing apparatus which simulates a cerebrospinal fluid flow.The progav 2.0 valve operates within the accepted tolerances in the horizontal position.The shunt assistant operates not within the accepted tolerance in the vertical position.Results: first, we performed a visual inspection of the progav 2.0 shunt system.No significant deformations or damage of the valves were detected during the visual inspection.Only particles in the delivery liquid and in the inlet are detected.Next, we tested the permeability, adjustability, and opening pressure of the valve, as well as the brake functionality and brake force.The opening pressure of the shuntassistant was out of tolerance, but all other specifications were met.The opening pressure of the shuntassistant was significantly lower than expected, shows an increased flow of liquid.Finally, we have dismantled the valves.Inside the progav 2.0 we have found build-up of substances (likely protein), in the shuntassistant were no visible deposits detected.Based on our investigation, we are unable to substantiate the clinical claim of under-drainage and dysfunction of adjustability.However, it is possible that the deposits observed inside the progav 2.0 could have caused the malfunction in the past.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 regulatory actions are required from our point of view.
Event or Problem Description
The investigatin is completed and the result will be submitted with this reoort.

• Brand Name: PROGAV 2.0 SYS M.SA25 U.SPRUNG RESERVOIR
• Common Device Name: HYDROCEPHALUS MANAGEMENT
• Manufacturer (Section D): CHRISTOPH MIETHKE GMBH & CO. KG; ulanenweg 2; potsdam, 14469 ; GM 14469
• MDR Report Key: 11164783
• Report Number: 3004721439-2020-00274
• Device Sequence Number: 3717517
• Product Code: JXG
• UDI-Device Identifier: 04041906136987
• UDI-Public: 4041906136987
• Combination Product (Y/N): Y
• Initial Reporter Country: GM
• PMA/510(K) Number: K161853
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/18/2021

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: 08/26/2023
• Device Model Number: FX428T
• Device Catalogue Number: FX428T
• Device Lot Number: 20039291
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/16/2020
• Supplement Date Received by Manufacturer: 01/11/2021
• Initial Report FDA Received Date: 01/13/2021
• Supplement Report FDA Received Date: 02/03/2021
• 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: 31 YR
• Patient Weight: 85