MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG PROGAV 2.0 SYS W/SA20 A.CONTROL RESERV.; HYDROCEPHALUS MANAGEMENT

Model Number	FX434T
Medical Device Problem Codes	Mechanical Problem (1384); Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	05/21/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information/ investigation result will be submitted in a supplemental report.
Event or Problem Description
It was reported that a progav 2.0 shuntsystem (#fx434t) was believed to have a malfunction.The patient underwent a revision procedure.No patient complications were reported as a result of the revision procedure.
Additional Manufacturer Narrative
Investigation: manufacturing and quality control data the progav® shuntsystem was manufactured by a qualified employee on august 2011.Deviations during assembly did not occur.The product was finally tested as article fv701t and released for packaging and sterilization and was sterilized by miethke.The progav® has a normal pressure range of 0 to 20 cmh2o.The parameters after completion of the valve assembly were tested at a flow rate of 5 ml/h or 50 ml/h at set pressures of 0, 5, 10 and 20 cmh2o, and were found to meet specifications.The valve was pre-adjusted to 5 cmh2o in accordance with the specification.The shuntassistant® has a fixed pressure of 20 cmh2o.The parameters after completion of the valve assembly were tested at a flow rate of 5 ml/h or 50 ml/h at a fixed pressure of 20 cmh2o, and were found to meet range the tolerances.All parameters (opening pressure, reflux, tightness, adjustability and brake function) have been inspected and approved during the manufacturing process.Result: an investigation was not possible because we have not received the release for investigation.It is possible that protein deposits inside the valves affect the function of the shuntsystem and have led to a malfunction.As described in scientific literature, the problem encountered is one of the known, inevitable risks of hc-therapy by shunt implants.However, we cannot finally clarify what influenced the malfunction, as this would require an examination 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.
Event or Problem Description
Approval for investigation received on 10/11/2021, so the investigation could be done.
Additional Manufacturer Narrative
Investigation: visual inspection: the following observations were made during the visual inspection: deformation of the housing deposits in the ped.Prechamber two cuts, in the catheter between the valves and between the ped.Prechamber and the progav valve measurement of surface of the housing: to verify whether the deformation had an effect on the plane-parallelism of the housing surface, this was measured using a dial gauge.Deformation detected: yes - measured value: -0.082 mm [tolerance (0 ± 0.02mm)] too much pressure on the valve, for example through the adjustment tool or resulting from a fall or hit to the head of the patient, can compromise the integrity of the valve.Permeability test: the test showed that the progav shunt system is permeable.During the test, liquid leaked from the cut between the ped.Prechamber and the valve.Computer control test: the computer controlled test showed the opening pressure of the shuntassistant, at a reference flow rate of 20 ml/h in a vertical position of the valve, to be 19.69 cmh2o.This is within the specified tolerance of 20 cmh2o +4/-2 cmh2o.The test could not be performed with the progav valve.A defective brake was detected upon checking the opening pressure at the time of receipt.Therefore, the valve cannot hold the pressure setting and the measurement would not be meaningful.Adjustability test: the progav was found to be adjustable to all pressure settings, but the brake function is not given, see section "braking force and brake function test".The shuntassistant is a fixed pressure valve, therefore the adjustability test is inapplicable.Braking force and brake function test: the brake function of the progav did not operate as expected.Due to the non-functionality of the brake function the braking force of the progav is unable to be measured.Internal inspection of product: in order to verify whether the investigated shunt system was compromised by the known risks of hydrocephalus therapy, e.G.By a build-up of natural substances (protein, blood, or tissue particles) in the cerebrospinal fluid, we have dismantled the shunt system.After dismantling of the valves, some deposits were found in both valves.Results: first, we would like to point out that the shunt system was explanted in may 2021.Such a long period of time can affect the characteristics of the valves.Based on our investigation results, we can identify a malfunction of the progav brake.A blockage of the shunt system could not be detected.We assume that the observed deformation is responsible for the functional impairment of the adjustability.Excessive pressure on the adjustment pin or a knock on the patient's head can impair the integrity of the valve.Additionally we are assuming that the detected deposits in the valves have caused the functional impairment.Deposits caused by natural substances in the cerebrospinal fluid, such as protein, blood or tissue particles, are among the known and unavoidable risks and side effects of hydrocephalus therapy.Small amounts of non-visible deposits/proteins might 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.From our point of view, no further regulatory actions are required.

• Brand Name: PROGAV 2.0 SYS W/SA20 A.CONTROL RESERV.
• Common Device Name: HYDROCEPHALUS MANAGEMENT
• Manufacturer (Section D): CHRISTOPH MIETHKE GMBH & CO KG; ulanenweg 2; potsdam, 14469 ; GM 14469
• Manufacturer (Section G): CHRISTOPH MIETHKE GMBH & CO KG; ulanenweg 2; potsdam, 14469 ; GM 14469
• Manufacturer Contact: joerg knebel ; ulanenweg 2; potsdam, 14469 ; GM 14469
• MDR Report Key: 12002772
• Report Number: 3004721439-2021-00164
• Device Sequence Number: 1099606
• Product Code: JXG
• UDI-Device Identifier: 04041906137328
• UDI-Public: 4041906137328
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K161853
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/10/2021

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: 08/03/2016
• Device Model Number: FX434T
• Device Catalogue Number: FX434T
• Device Lot Number: 20014448
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/30/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/21/2021
• Supplement Date Received by Manufacturer: 09/06/2021; 10/15/2021
• Initial Report FDA Received Date: 06/15/2021
• Supplement Report FDA Received Date: 09/14/2021; 11/10/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/04/2011
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown