MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG PROSA WITH PROGAV 2.0; HYDROCEPHALUS MANAGEMENT

Model Number	FX992T
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	10/13/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation: visual inspection: a deformation of the outer housing of the prosa valve was observed through the visual inspection.The prosa valve housing was subsequently measured and confirmed the presence of a deformation.The housing deformation measured at -0.0715 mm, outside the tolerance of 0 ± 0.02 mm.Permeability test: a permeability test has shown that both valves are permeable.Adjustment test: both valves were tested and are not adjustable.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 prosa and the progav 2.0.A deformation of the outer housing of the progav 2.0 valve was observed through the visual inspection.The deformation was confirmed through a measurement of the parallelism of the valve housing.Additional were observed, tissue residues on the ligature of the products.Next, we tested the permeability of the valves.Both valves were shown to be permeable.Additionally, we tested the adjustability as well as the brake functionality and brake force of the valves.The valves were not adjustable.The brake functionality was fully operational, however due to non- adjustability of the valves, it was not possible to measure the brake force.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 were 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 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 (b)(4) no further regulatory actions are required from our point of view.
Event or Problem Description
It was reported that there was a problem with a prosa shunt system with progav 2.0.The valves are not adjustable.Patient information: age: (b)(6) years.Weight: (b)(6) kg.Height: 117 cm.Gender: unknown.Date of implantation: (b)(6) 2018.Date of removal: (b)(6) 2020.

• Brand Name: PROSA WITH PROGAV 2.0
• Common Device Name: HYDROCEPHALUS MANAGEMENT
• Manufacturer (Section D): CHRISTOPH MIETHKE GMBH & CO KG; ulanenweg 2; potsdam, 14469 ; GM 14469
• MDR Report Key: 10743775
• Report Number: 3004721439-2020-00224
• Device Sequence Number: 3312550
• Product Code: JXG
• UDI-Device Identifier: 04041906138431
• UDI-Public: 04041906138431
• 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: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/23/2020

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: 09/23/2023
• Device Model Number: FX992T
• Device Catalogue Number: FX992T
• Device Lot Number: 20039337
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/15/2020
• Initial Report FDA Received Date: 10/27/2020
• 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: 4 YR
• Patient Weight: 21