MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG PROSA SYS W.PROGAV 2.0 A.CONTROL RESERV.; HYDROCEPHALUS MANAGEMENT

Model Number	FX991T
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	03/26/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturer evaluation: investigation on-going.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted.
Event or Problem Description
It was reported that a prosa system with progav 2.0 (part # fx991t) was implanted during a procedure performed on (b)(6) , 2018.According to the complainant, the valves were believed to be operating in under-drainage.The ventricles of the patient were dilated.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) years.Weight: 15 kilograms (kg).Height: 101 centimeters (cm).Gender: male.
Additional Manufacturer Narrative
Investigation: visual inspection: a deformation of the outer housing of the prosa valve, significant particles in the delivery liquid, deposits in the inlet and outlet spout of the valves were observed through the visual inspection.The prosa valve housing was subsequently measured and confirmed the presence of a deformation.The housing deformation measured at - 0.059 mm, outside the tolerance of 0 ± 0.02 mm.Permeability test: a permeability test has indicated that the prosa valve has a blockage and that the progav 2.0 is permeable.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 valves are tested in both the horizontal as well as the vertical positions.Because the prosa valve is not permeable, a computer controlled test is not possible.The results show that the progav 2.0 is operating not within the specified tolerances in the horizontal position.A slowed outflow was detected.Adjustment test: the prosa was tested and is not adjustable throughout the normal range.The progav 2.0 is adjustable to all pressure settings.Braking force and brake function test: the brake functionality test has shown that the brake function of the progav 2.0 is fully operational and the braking force is within the given tolerances.The brake function of the prosa 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 prosa shunt system.A deformation of the outer housing of the prosa valve was observed through the visual inspection.The deformation was confirmed through a measurement of the parallelism of the valve housing.Additional some particles in the delivery liquid and deposits in the inlet and outlet spouts of the valves were visible.Next, we tested the permeability, adjustability, and opening pressure of the valve, as well as the brake functionality and brake force.The prosa valve was neither permeable nor adjustable.Furthermore, while the brake functionality was present, the braking force was unable to be measured due to the inability of the valve to hold a set pressure.The opening pressure of the progav 2.0 valve was out of tolerance, but all other specifications were met.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 valves shows an slower flow of liquid and a blockage 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 prosa valve could not be determined through our investigation.Significant outside pressure, for example by too much force from the prosa 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.

• Brand Name: PROSA SYS W.PROGAV 2.0 A.CONTROL RESERV.
• Common Device Name: HYDROCEPHALUS MANAGEMENT
• Manufacturer (Section D): CHRISTOPH MIETHKE GMBH & CO KG; ulanenweg 2; potsdam, 14469 ; GM 14469
• MDR Report Key: 11734804
• Report Number: 3004721439-2021-00098
• Device Sequence Number: 14433610
• Product Code: JXG
• UDI-Device Identifier: 04041906138493
• UDI-Public: 4041906138493
• 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: 2018
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/09/2021

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: 08/07/2023
• Device Model Number: FX991T
• Device Catalogue Number: FX991T
• Device Lot Number: 20038938
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/31/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/31/2021
• Supplement Date Received by Manufacturer: 05/28/2021
• Initial Report FDA Received Date: 04/27/2021
• Supplement Report FDA Received Date: 06/09/2021
• 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: 5 YR
• Patient Weight: 15