MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG PROGAV SYS W/SA 20 A.CONTROL RESERVOIR; HYDROCEPHALUS VALVES

Model Number	FV434T
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	08/29/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This complaint was reopened in reference to (b)(4).Investigation: visual inspection: except scratches no significant deformations or damage were detected.Although no significant deformations or damage of the valve were detected during the visual inspection, the measurement of the plane parallelism has revealed that the valve is with a value of -0.0405mm outside tolerance of 0 ± 0.02 mm.Permeability test: a permeability test has shown that the valve is permeable.Adjustment test: the progav® was tested and is not adjustable throughout the normal range.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 claim of overdrainage, the opening pressure is measured using a miethke computer controlled testing apparatus which simulates a cerebrospinal fluid flow.The first measurement in the horizontal body position has shown that the valve with a value of 7.04 cmh2o is slightly outside the permissible tolerance.We performed a second measurement.The measured values of the second measurement were now 7.32 cmh2o.This indicates that the valve is still outside the permissible tolerance, but an improvement in the values can be observed.Presumably further testing would lead to a continued improvement of the values, since the distilled water would flush any deposits inside the valve out.The measurements confirm the suspicion of overdrainage.Result: first, we performed a visual inspection of the progav®.Although except scratches no significant deformations or damage of the valve were detected during the visual inspection, the measurement of the plane parallelism has revealed that the valve is with a value of -0.0405mm outside tolerance of 0 ± 0.02 mm.Significant outside pressure, for example by too much force from the progav® adjustment tool or by a fall or impact to the head of the patient, can compromise the integrity of the valve.Next, we tested the permeability, adjustability, and opening pressure of the valve, as well as the brake functionality and brake force.The valve is permeable, the break is fully functional and the break force is within the given tolerance.The adjustment test has revealed that the progav® is not adjustable throughout the normal range.The first measurement of the opening pressure in the horizontal body position has shown that the valve is slightly outside the permissible tolerance.We performed a second measurement.The measured values of the second measurement were still outside the permissible tolerance, but an improvement in the values can be observed.Presumably further testing would lead to a continued improvement of the values, since the distilled water would flush any deposits inside the valve out.The measurements confirm the suspicion of overdrainage.Finally, we have dismantled the valve.Inside the valve we have found a small amount of build-up of substances (likely protein).Based on our investigation, we observed 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 hg-therapy by shunt implants.We can exclude a defect at the time of release.The valve 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
It was reported to miethke that a progav sys w/sa 20 a.Control reservoir (# fv434t) was implanted during a procedure performed on (b)(6) 2017.According to the complainant, the valve was believed to be overdrainage.The patient underwent a revision procedure on (b)(6) 2017.The complainant device was returned to the manufacturer for evaluation.Further details were not provided.Height: 135cm.

• Brand Name: PROGAV SYS W/SA 20 A.CONTROL RESERVOIR
• Common Device Name: HYDROCEPHALUS VALVES
• 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: 12964544
• Report Number: 3004721439-2021-00815
• Device Sequence Number: 4416376
• Product Code: JXG
• UDI-Device Identifier: 04041906132460
• UDI-Public: 4041906132460
• 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: 2017
• Device Explanted Year: 2017
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/08/2021

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: 07/31/2015
• Device Model Number: FV434T
• Device Catalogue Number: FV434T
• Device Lot Number: 4502824903
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/04/2017
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/13/2017
• Initial Report FDA Received Date: 12/08/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/26/2010
• 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: 7 MO
• Patient Sex: Unknown
• Patient Weight: 23 KG