MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG PROSA VALVE W/MININAV 5 DIST.CATHETER; HYDROCEPHALUS VALVES

Model Number	FV708T
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	02/01/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This complaint was reopened in reference to (b)(4).Investigation: visual inspection: scratches on the outer housing of the valve were observed through the visual inspection., but no significant deformations or damage were detected.Even though no significant visual deformations were observed, the measurement of the plane parallelism has shown that the valve is slightly outside the permissible tolerance of 0 ± 0.02 mm with a value of -0.0365 mm.Excessive pressure on the valve body can damage the housing membrane and impair its function.Permeability test: a permeability test has shown that the valve is permeable with difficulty.We assume that deposits in the valve could have impared the permeablility.Adjustment test: the prosa® valve 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.Results: first, we performed a visual inspection of the valve.Even though no significant visual deformations were observed, the measurement of the plane parallelism has shown that the valve is slightly outside the permissible tolerance of 0 ± 0.02 mm with a value of -0.0365 mm.Too much pressure on the housing can led to damage of the membrane.The exact cause of the deformation remains unclear.Next, we tested the permeability, adjustability, as well as the brake functionality and brake force.The valve was permeable with difficulty and met all other specifications.Finally, we have dismantled the valve.Inside the valve we have found a build-up of substances (likely protein).Based on our investigation, we are unable to substantiate the clinical claim of occlusion.At the time of our investigation the valve was shown to be permeable, albeit with difficulty.However, it is possible that the deposits observed inside the valve could have caused the malfunction in the past.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 (b)(4).No further regulatory actions are required from our point of view.
Event or Problem Description
It was reported that a prosa valve.(#fv708t) was implanted during a procedure performed on (b)(6) 2015.According to the complainant, the valve was believed to be blocked.The patient underwent a revision procedure on (b)(6) 2017.The complainant device was returned to the manufacturer for evaluation.

• Brand Name: PROSA VALVE W/MININAV 5 DIST.CATHETER
• Common Device Name: HYDROCEPHALUS VALVES
• Manufacturer (Section D): CHRISTOPH MIETHKE GMBH & CO KG; ulanenweg 2; potsdam, 14469 ; GM 14469
• MDR Report Key: 12658488
• Report Number: 3004721439-2021-00699
• Device Sequence Number: 4480848
• Product Code: JXG
• UDI-Device Identifier: 04041906133573
• UDI-Public: 4041906133573
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K120559
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2017
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/19/2021

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 Model Number: FV708T
• Device Catalogue Number: FV708T
• Device Lot Number: 20016949
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2017
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/09/2017
• Initial Report FDA Received Date: 10/19/2021
• 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: 18 MO