MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG PROSA VALVE; SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

Model Number	FV701T
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	10/03/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The adverse event is filed under aic reference (b)(4).Investigation on-going.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted.
Event or Problem Description
According to the complainant the patient was implanted with a prosa valve 10 years ago.Reportedly the surgeon recently had to do a shunt revision and it appeared the prosa wasn't working so the surgeon explanted the valve and wants to send it to for testing.No patient complications were reported as a result of the revision procedure.
Additional Manufacturer Narrative
Visual inspection: during the investigation, scratches and a visible deformation of the outer housing of the prosa, were determined.Permeability test: a permeability test has shown that the prosa is permeable.Computer controlled test: to determine the opening pressure of the prosa a miethke computer controlled testing apparatus which simulates a cerebrospinal fluid flow is used.The valve is tested in both the horizontal as well as the vertical positions.The results show that the prosa is operating within the acceptable tolerance in either position.Adjustment test: the m.Blue valve 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 did not operate as expected.The results indicate that the rotor no longer performs as required.Internal inspection: after dismantling of the valve, deposits were found in prosa results: according to the results of the investigation, it was determined that the valve was not adjustable.The detected deformation of the outer housing led to the dysfunction.At the time of the examination, we are unable to explain how the deformation occurred.An excessive pressure with the adjustment tool can lead to this type of deformation and affect the function of adjustment.The examination of the return has been completed with the drafting of this report.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.

• Brand Name: PROSA VALVE
• Common Device Name: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): CHRISTOPH MIETHKE GMBH & CO KG; ulanenweg 2; potsdam, 14469 ; GM 14469
• MDR Report Key: 23341380
• Report Number: 2916714-2025-00068
• Device Sequence Number: 9470190
• Product Code: JXG
• UDI-Device Identifier: 04041906133023
• UDI-Public: (01)04041906133023(17)231003(10)20039433
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/18/2025
• Report Date (Section F): 10/20/2025

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: 10/03/2023
• Device Model Number: FV701T
• Device Catalogue Number: FV701T
• Device Lot Number: 20039433
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 10/03/2025
• Device Age: 7 YR
• Event Location: Hospital
• Date Report to Manufacturer: 10/03/2025
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/20/2025
• Supplement Report FDA Received Date: 11/18/2025
• 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 Sex: Unknown
• Date Report Sent to FDA: 10/20/2025