MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG PROGAV 2.0 SYS SA2.0 15 & CONTROL RES.; HYDROCEPHALUS AND ICP MANAGEMENT

Model Number	FX550T
Medical Device Problem Codes	Mechanical Problem (1384); Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	02/29/2024
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 sys sa2.0 15 & control res.(part # fx550t) was implanted during a revision surgery on (b)(6) 2023.According to the complainant the shunt setting was at 10.Reportedly the patient underwent a shunt study on (b)(6) 2023 that was reported to be successful.During this time the patient also underwent a cervical spine mri on (b)(6) 2023 and a brain mri on (b)(6) 2023.The patient went to an outside hospital on (b)(6) 2023 with headaches where the shunt was checked and reported to be at a setting of 2.This was then changed back to 10.On (b)(6) 2024 the patient returned to the original clinic due tot high pressure symptoms.An x-ray was performed and the valve was found to be set at 9.The patient underwent a revision surgery on (b)(6) 2024 to a device from another supplier.Testing immediately prior to removal revealed the shunt to be set at 10 with the programmer device.No attempts to change the shunt were made.The adverse event is filed under aic reference (b)(4).
Additional Manufacturer Narrative
Corrected information: age at time of event - a2.Additional information: patient weight - a4.Item serial number, lot number, and expiration date - d4.Device returned to manufacturer d9.Approximate age of device - f9.Visual inspection: during the investigation, no significant deformations or damage of the valves was determined.Permeability test: a permeability test has shown that all components are 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 brake function is fully operational and the braking force is within the given tolerances.Internal inspection: after dismantling of the valve, no deposits were found in progav 2.0.To make the deposits in the valve more visible, they were colored using a staining solution.Result: based on our investigation results, we cannot determine functional deviations or other abnormalities in the product.How the abovementioned functional impairment occurred is not clear to us at the time of examination.

• Brand Name: PROGAV 2.0 SYS SA2.0 15 & CONTROL RES.
• Common Device Name: HYDROCEPHALUS AND ICP MANAGEMENT
• Manufacturer (Section D): CHRISTOPH MIETHKE GMBH & CO KG; ulanenweg 2; potsdam, 14469 ; GM 14469
• MDR Report Key: 18939506
• Report Number: 2916714-2024-00064
• Device Sequence Number: 6760195
• Product Code: JXG
• UDI-Device Identifier: 04041906503154
• UDI-Public: 4041906503154
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/18/2024
• Report Date (Section F): 03/20/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/13/2024
• Device Model Number: FX550T
• Device Catalogue Number: FX550T
• Device Lot Number: 20070966
• 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: 02/27/2024
• Device Age: 8 MO
• Event Location: Hospital
• Date Report to Manufacturer: 02/27/2024
• 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: 03/20/2024
• Supplement Report FDA Received Date: 04/18/2024
• 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 Sex: Female
• Date Report Sent to FDA: 03/20/2024