MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG PROGAV SYS W.SA 20 A.CONTROL RESERVOIR; HYDROCEPHALUS MANAGEMENT

Model Number	FV434T
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	12/18/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation on going.Additional informations will be provided in a supplemental report.
Event or Problem Description
It was reported that there was a problem with a progav.The surgeon reported that the valve is not adjustable and it was therefore replaced.Implantation: (b)(6) 2012.Removal: (b)(6) 2020.Patient data: age y: (b)(6), height cm: 180, weight (b)(6), gender: unknown.
Additional Manufacturer Narrative
Investigation: visual inspection: visible particles in the reservoir and a calcified part of catheter, but no significant deformations or damage of the valves were detected during the visual inspection.The progav valve housing was subsequently measured and indicated the presence of a deformation.The housing deformation measured at -0.0535 mm, outside the tolerance of 0 ± 0.02 mm permeability test: a permeability test has shown that both valves are 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.Results: first, we performed a visual inspection of the progav shunt system.A deformation of the outer housing of the progav valve was observed through the visual inspection.The deformation was indicated with the measurement of the plane parallelism of the valve housing.Additional were visible particles in the reservoir and a calcified part of catheter detected.Next, we tested the permeability, adjustability, as well as the brake functionality and brake force.The valve was permeable but could not be adjusted to all settings.Finally, we have dismantled the valves.Inside both valves we have found build-up of substances (likely protein).Based on our investigation, we confirm that the valve was non-adjustable 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.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 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
Investigation is completed the result will be submitted with this follow up report.

• Brand Name: PROGAV SYS W.SA 20 A.CONTROL RESERVOIR
• Common Device Name: HYDROCEPHALUS MANAGEMENT
• Manufacturer (Section D): CHRISTOPH MIETHKE GMBH & CO KG; ulanenweg 2; potsdam, 14469 ; GM 14469
• MDR Report Key: 11202285
• Report Number: 3004721439-2020-00283
• Device Sequence Number: 19368204
• Product Code: JXG
• UDI-Device Identifier: 04041906132460
• UDI-Public: 4041906132460
• 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: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/25/2021

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 Model Number: FV434T
• Device Catalogue Number: FV434T
• Device Lot Number: 20015889
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/22/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/22/2020
• Supplement Date Received by Manufacturer: 01/18/2021
• Initial Report FDA Received Date: 01/20/2021
• Supplement Report FDA Received Date: 02/03/2021
• 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: 30 YR
• Patient Weight: 80