MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG PROGAV 2.0 WITH SHUNTASSISTANT 2.0 20; SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

Model Number	FX642T
Medical Device Problem Code	Unintended System Motion (1430)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	12/02/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation on-going.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted.
Event or Problem Description
It was reported to aesculap inc.That a progav 2.0 with shuntassistant 2.0 20 (part# fx642t) was implanted on an unspecified date.According to the complainant upon attempting to reprogram valve the device would not respond to adjustment.The valve is stuck at 5.Reportedly a revision is planned for sometime after the 2024 holiday season.The adverse event is filed under aic reference (b)(4).
Additional Manufacturer Narrative
Additional information: a2 patient age, a3 patient sex, a4 patient weight, b7 relevant history, d4 device information, d6a implant date,d6b explant date, d9 device returned to manufacturer, f9 approximate age of device.Visual inspection: during the investigation, no significant deformations or damage of the valves was determined.Permeability test: a permeability test has shown that the valve is permeable.Computer controlled test: to investigate the claim of over- drainage, the opening pressure is measured using a miethke computer controlled testing apparatus which simulates a cerebrospinal fluid flow.The valve is tested in the horizontal position.The results show that the valve operates within the accepted tolerances in the horizontal position.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 function is given.Internal inspection: after dismantling of the valve, deposits were found.Result : based on our investigation results, we can determine visible deposits.The deposits had no effect upon the specifications at the time of the examination.Deposits caused by substances naturally present in the patient's body, such as organic material, blood or tissue particles, are among the known and unavoidable risks and side effects of hydrocephalus therapy.Even small amounts of organic material can affect the integrity of the valve.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: PROGAV 2.0 WITH SHUNTASSISTANT 2.0 20
• 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: 20976498
• Report Number: 2916714-2024-00204
• Device Sequence Number: 8602411
• Product Code: JXG
• UDI-Device Identifier: 04041906502003
• UDI-Public: (01)04041906502003(11)230418(17)280417(10)20059076
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/25/2025
• Report Date (Section F): 12/19/2024

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
• Device Model Number: FX642T
• Device Catalogue Number: FX642T
• Device Lot Number: 20065334
• 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: 02/12/2024
• Device Age: 21 MO
• Event Location: Hospital
• Date Report to Manufacturer: 12/02/2024
• 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: 12/19/2024
• Supplement Report FDA Received Date: 02/25/2025
• 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 Age: 24 MO
• Patient Sex: Female
• Patient Weight: 14 KG
• Date Report Sent to FDA: 12/19/2024