MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG PROGAV 2.0 SYS WITH SA25 AND SPRING RESERVOIR; HYDROCEPHALUS MANAGEMENT

Model Number	FX428T
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	10/12/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a progav 2.0 shuntsystem was implanted during a procedure performed in on (b)(6) 2019.According to the complainant, the shunt system was believed to be operated in over-drainage.The patient underwent a revision procedure on (b)(6) 2021.No patient complications were reported as a result of the revision procedure.Age: (b)(6) years, height: unknown, weight: unknown, gender: female.
Additional Manufacturer Narrative
Manufacturing and quality control data: the progav® 2.0 shunt system was manufactured by a qualified employee in august 2018.Deviations during assembly did not occur.The system was sterilized by miethke and released for shipment after final inspection.For the purposes of this investigation, the progav® 2.0 shunt system is comprised of a progav® 2.0 adjustable pressure valve with a normal pressure range of 0 to 20 cmh2o and a shuntassistant® fixed pressure valve with a fixed pressure range of 25.The shunt system was inspected as article fx428t.All parameters have been inspected and approved during the manufacturing process.All parameters have been assessed as meeting specifications.Visual inspection: a deformation of the outer housing of the progav®2.0 valve was observed through the visual inspection.Permeability test: a permeability test has shown that both valves are permeable.Computer controlled test: to investigate the claim of over/under-drainage, the opening pressure is measured using 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 is operating within the accepted tolerance in the horizontal position.The shuntassistant® is operating not within the specified tolerances in the vertical position.Adjustment test: the progav® 2.0 was tested and is adjustable to all specified pressures.Klick 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 valves, some deposits were found in both valves.Results: based on our investigation, we confirm that the valve shows an increased flow of liquid at the time of our investigation.This is likely due to the deposits observed inside the valves.As described in scientific literature, the problem encountered is one of the known, inevitable risks of hc-therapy by shunt implants.We can exclude a defect at the time of release.The shunt system 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 SYS WITH SA25 AND SPRING RESERVOIR
• Common Device Name: HYDROCEPHALUS MANAGEMENT
• Manufacturer (Section D): CHRISTOPH MIETHKE GMBH & CO KG; ulanenweg 2; potsdam, 14469 ; GM 14469
• Manufacturer (Section G): CHRISTOPH MIETHKE GMBH & CO KG; ulanenweg 2; potsdam, 14469 ; GM 14469
• Manufacturer Contact: joerg knebel ; ulanenweg 2; potsdam, 14469 ; GM 14469
• MDR Report Key: 12804560
• Report Number: 3004721439-2021-00300
• Device Sequence Number: 5575370
• Product Code: JXG
• UDI-Device Identifier: 04041906136987
• UDI-Public: 4041906136987
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K161853
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/12/2021

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 Expiration Date: 08/14/2023
• Device Model Number: FX428T
• Device Catalogue Number: FX428T
• Device Lot Number: 20039094
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/20/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/20/2021
• Initial Report FDA Received Date: 11/12/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/05/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 2 YR
• Patient Sex: Female