MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG PROGAV SYS PED.W/SA 20 A.BURRH.RES.; HYDROCEPHALUS MANAGEMENT

Model Number	FV448T
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	10/04/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A deformation of the outer housing of the progav valve was observed through the visual inspection.The measurement of the plane parallelism could confirm that with a value of -0,081mm the housing membrane is clearly outside tolerance (0 ± 0.02 mm).Furthermore deposits (incrustations) were found on the catheter.A permeability test has shown that both valves are permeable.During the test, bloody liquid leaked from the shunt system.To investigate the claim of 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 both valves are not operating within the acceptable tolerance in either position.Both valves showed an accelerated outflow.The progav was tested and is not adjustable throughout the normal range.The brake functionality test has shown that the brake function is operational, however the braking force cannot be measured due to the non-adjustability of the valve.(see section adjustment test).After dismantling of the valves, deposits were found in both valves.Based on our investigation results, we can determine an accelerated outflow in the shunt system as well as a non-adjustablity in the progav valve at the time of the investigation.The detected deposits could be named as the cause of the malfunctions.Proteins in the cerebrospinal fluid can influence the function temporarily and are known side effects in hydrocephalus therapy.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.
Event or Problem Description
It was reported that a progav shunt system (part # fv448t) was implanted during a procedure performed on (b)(6) 2011.According to the complainant, the shunt system was believed to be operated in overdrainage.The patient underwent a revision procedure performed on (b)(6) 2022.The complaint device was returned to the manufacturer for evaluation.No patient complications were reported as a result of the revision procedure.Age: 12 years and 3 months.Height: 165 centimeters (cm).Weight: 61 kilograms (kg).Gender: male.

• Brand Name: PROGAV SYS PED.W/SA 20 A.BURRH.RES.
• 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: 15849820
• Report Number: 3004721439-2022-00349
• Device Sequence Number: 15084266
• Product Code: JXG
• UDI-Device Identifier: 04041906132682
• UDI-Public: 4041906132682
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K103003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/22/2022

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 Model Number: FV448T
• Device Catalogue Number: FV448T
• Device Lot Number: 20008576
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/25/2022
• Initial Report FDA Received Date: 11/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/12/2008
• 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: 12 YR
• Patient Sex: Male
• Patient Weight: 61 KG