MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG PROGAV VALVE; HYDROCEPHALUS MANAGEMENT

Model Number	FV410T
Medical Device Problem Codes	Mechanical Problem (1384); Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	07/16/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation: visual inspection: a deformation of the outer housing of the progav valve was observed through the visual inspection.The progav valve housing was subsequently measured and confirmed the presence of a deformation.The housing deformation measured at -0.0365 mm, outside the tolerance of 0 ¿ 0.02 mm.Permeability test: a permeability test has shown that the valve is permeable.Adjustment test: the progav was tested and is not adjustable throughout the normal range.Braking force and brake function test: 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.Computer controlled test: 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 results show that the valve operates within the accepted tolerance in the horizontal position.Result : first, we performed a visual inspection of the progav.A deformation of the outer housing of the progav valve was observed through the visual inspection.This deformation was confirmed through a measurement of the plan parallelism.Next, we tested the permeability, adjustability, and opening pressure of the valve, as well as the brake functionality and brake force.The valve was not adjustable.Furthermore, while the brake functionality was present, the braking force was unable to be measured due to the non- adjustability of the valve.All other specifications were met.Finally, we have dismantled the valve.Inside the valve we have found a build-up of substances (likely protein).Based on our investigation, we confirm that the was non-adjustable, but an increased flow of liquid could not be detected at the time of investigation.This is likely due to the deposits observed inside the valve.As described in scientific literature, the problem encountered is one of the known, inevitable risks of hc-therapy by shunt implants.The cause of the deformation of the progav valve could not be determined through our investigation.Significant outside pressure, for example by too much force from the progav adjustment tool or by a fall or impact to the head of the patient, can compromise 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 (b)(4).No further regulatory actions are required from our point of view.
Event or Problem Description
It was reported that a progav (part # fv410t) was implanted during a procedure performed on (b)(6) 2012.According to the complainant, the shunt system was believed to be operating in under-drainage and was difficult to adjust.The patient underwent a revision procedure on (b)(6) 2021.The complaint device was returned to the manufacturer for evaluation.No patient complications were reported as a result of the revision procedure.Age: (b)(6) height: 180 centimeters (cm) weight: (b)(6) gender: male same event: #medwatch: 3004721439-2021-00220.

• Brand Name: PROGAV VALVE
• Common Device Name: HYDROCEPHALUS MANAGEMENT
• Manufacturer (Section D): CHRISTOPH MIETHKE GMBH & CO KG; ulanenweg 2; potsdam, 14469 ; GM 14469
• MDR Report Key: 12289256
• Report Number: 3004721439-2021-00219
• Device Sequence Number: 14412923
• Product Code: JXG
• UDI-Device Identifier: 04041906132071
• UDI-Public: 4041906132071
• 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: 2012
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/06/2021

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: 12/04/2016
• Device Model Number: FV410T
• Device Catalogue Number: FV410T
• Device Lot Number: 20015420
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/20/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/20/2021
• Initial Report FDA Received Date: 08/06/2021
• 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: 18 YR
• Patient Weight: 100