MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG PROSA SYS M.PROGAV 2.0 U.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	02/14/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The investigation has not yet begun.Additional informations / investigation results will be provided in a supplemental report.
Event or Problem Description
It was reported that there was a problem with a prosa shuntsystem.The surgeon suspected an underdrainage patient information: age: (b)(6)year, height: 167 cm, weight: (b)(6) kg, gender: female.Implantation: (b)(6) 2019.Explanation: (b)(6) 2021.
Additional Manufacturer Narrative
Investigation: visual inspection: a deformation of the outer housing of the prosa valve and scratches on the progav 2.0 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 -0.062 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 adjustable to all specified pressures.Braking force and brake function test: the brake functionality tests have shown that the brake functions are fully operational and the braking forces are within the given tolerances.Computer controlled test: to investigate the clinical claim of underdrainage, the opening pressure is measured using a miethke computer controlled testing apparatus which simulates a cerebrospinal fluid flow.Both valves are operating within acceptable tolerances.Results: first, we performed a visual inspection of the prosa shunt system.Scratches on the progav 2.0 and 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.Next, we tested the permeability, adjustability, and opening pressure of the valve, as well as the brake functionality and brake force.The valves operated as expected and met all specifications.Finally, we have dismantled the valves.Inside both valves we have found slight build-up of substances (likely protein).Based on our investigation, we are unable to substantiate the clinical claim of under-drainage.At the time of our investigation, the valves were operating within the specified tolerances.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 M.PROGAV 2.0 U.CONTROL RESERV.
• Common Device Name: HYDROCEPHALUS MANAGEMENT
• Manufacturer (Section D): CHRISTOPH MIETHKE GMBH & CO KG; ulanenweg 2; potsdam, 14469 ; GM 14469
• MDR Report Key: 11515389
• Report Number: 3004721439-2021-00048
• Device Sequence Number: 17101206
• 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: 2019
• Device Explanted Year: 2021
• 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): 04/22/2021

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: 04/25/2024
• Device Model Number: FX991T
• Device Catalogue Number: FX991T
• Device Lot Number: 20041877
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/23/2021
• Supplement Date Received by Manufacturer: 03/23/2021
• Initial Report FDA Received Date: 03/18/2021
• Supplement Report FDA Received Date: 04/22/2021
• 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: 60 YR
• Patient Weight: 130