MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG PROGAV 2.0 SYS W/SA25 A.SPRUNG RESERVOIR; HYDROCEPHALUS AND ICP MANAGEMENT

Model Number	FX428T
Medical Device Problem Code	Calibration Problem (2890)
Health Effect - Clinical Codes	Headache (1880); Failure of Implant (1924); Nausea (1970)
Date of Event	01/31/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to aesculap inc.That a progav 2.0 sys sa2.0 25 & sprung reserv.(part # fx577t) was implanted approximately 9 years ago.According to the complainant the patient underwent an adjustment.During the adjustment, the patient immediately was adamant that the shunt failed and wanted it replaced.Reportedly the patient was exhibiting headache and nausea after the adjustment.The patient underwent a revision surgery on (b)(6) 2024.The adverse event is filed under aic reference (b)(4).
Additional Manufacturer Narrative
Visual inspection: during the investigation, scratches and organic deposits on the outer housing of the valves, but no significant deformations or damage were determined.Permeability test: a permeability test has shown that all components are permeable.Computer controlled test: to investigate the opening pressure of the valves, they were tested with a miethke computer controlled testing apparatus which simulates a cerebrospinal fluid flow.The valves are tested in both the horizontal as well as the vertical positions.The results show that the progav 2.0 operates within the accepted tolerance in the horizontal position.The shuntassistant does not operate within the specified tolerances in the vertical position.An accelerated outflow of shuntassistant could be determined.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 operates as expected and the braking force is within the given tolerances.Internal inspection: after dismantling of the valves, deposits were found in both valves.To make the deposits in the shunt system more visible, they were colored using a staining solution.Results: based on our investigation results, we can determine visible deposits in the progav 2.0.The deposits visible in the valve had no effect upon the specifications at the time of the examination.The adjustment difficulties complained about could not be confirmed.Based on our test results, we can determine an accelerated outflow at the shuntassistant.The deposits visible in the valve may have led to the change in flow rate.Deposits caused by substances naturally present in the patient's body, such as protein, 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.The cathters and the sprung reservoir met the specification.

• Brand Name: PROGAV 2.0 SYS W/SA25 A.SPRUNG RESERVOIR
• Common Device Name: HYDROCEPHALUS AND ICP MANAGEMENT
• Manufacturer (Section D): CHRISTOPH MIETHKE GMBH & CO KG; ulanenweg 2; potsdam, 14469 ; GM 14469
• MDR Report Key: 18981770
• Report Number: 2916714-2024-00067
• Device Sequence Number: 6299024
• Product Code: JXG
• UDI-Device Identifier: 04041906136987
• UDI-Public: 4041906136987
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/26/2024
• Report Date (Section F): 03/26/2024

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: 06/26/2020
• Device Model Number: FX428T
• Device Catalogue Number: FX428T
• Device Lot Number: 20027032
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 02/29/2024
• Event Location: Hospital
• Date Report to Manufacturer: 02/29/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/26/2024
• 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: 41 YR
• Patient Sex: Female
• Patient Weight: 94 KG
• Date Report Sent to FDA: 03/26/2024