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

Model Number FX441T

Device Problem Infusion or Flow Problem (2964)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 07/14/2020

Event Type  Injury  

Manufacturer Narrative

An investigation was not possible, because the product was not send in because covid-19.The shunt system was inspected as article fx441t.All parameters are inspected and signed during the manufacturing process.All parameters have been assessed as meeting specifications.Result: as described in our instructions for use, in the treatment of hydrocephalus with shunts, the following complications may arise (as described in scientific literature): infections, blockages caused by protein and/or blood in the cerebrospinal fluid or over-/ and under-drainage.Due to violent shocks from the outside (accident, fall, etc.) the integrity of the shunt may be endangered.However, we cannot finally clarify what influenced the product condition, as this would require an examination of the shunt system.Based on our documentation however we can exclude a defect at the time of release.The progav® 2.0 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 Description

It was reported that there was a problem with a progav 2.0 shunt system.The first surgery was performed on (b)(6) 2018, but as the ventricles expanded and the symptoms worsened.The pressure setting was also lowered but ventricular contraction was not seen.Therefore there was a high possibility of shunt dysfunction and clogging.The surgeon decided to perform a revision surgery on (b)(6) 2020.The surgeon tried pumping several times, but no improvement.The removed valve was not blocked.Further informations are not available.The product was not send in for investigation because covid-19.

Manufacturer Narrative

Investigation.Visual inspection: significantly scratches on the casing of progav 2.0 and the prechamber.Permeability test: the test showed that the progav 2.0 shunt system is permeable.Computer controlled test: the computer controlled test has shown the opening pressure of the progav 2.0 at a reference flow rate of 20 ml/hr in a horizontal position, to be 5.21 cmh2o.This is within the specified tolerance of 4 cmh2o ± 3 cmh2o.An applied pressure of 4 cmh2o, with the device in the horizontal position is expected to have a resultant opening pressure of 4 cmh2o ± 3 cmh2o.Additionally, the shunt assistant was tested according to standard procedure in the horizontal and vertical position.At a fixed opening pressure of 20 cmh2o in the vertical position, a pressure of 22 cmh2o ± 2 cmh2o is expected.The results indicated that at a reference flow of 20 ml/hr in the vertical position, the shunt assistant had a pressure of 6.39 cmh2o.This is not within the specified tolerance of 22 cmh2o ± 2 cmh2o.Additional testing did not significantly change the results.According to our results, we can confirm the presence of an overdrainage.The test, performed in the horizontal position at a reference flow of 20 ml/hr, has shown that the shunt assistant with a result of 1.10 cmh2o is operating within the specified tolerance (2 cmh2o ± 2 cmh2o).Adjustability test: the progav 2.0 was found to be adjustable to all pressure settings.The shunt assistant is a fixed pressure valve, therefore the adjustability test is inapplicable.Braking force and brake function test: the braking force of the progav 2.0 was not within the specified tolerance, but the brake function operated as expected.The braking force is lower than the tolerance allowed.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, slightly deposits were found in both valves.Results: based on our investigation, we are not able to substantiate the claim of "blockage".We assume that the observed deposits may have temporarily led to a functional impairment of the shunt system.The additional malfunction of the braking force could have been caused by excessive pressure of the adjustment tool and could also affect the integrity of the valve.It is also possible that the pumping of the prechamber may have caused the deposits in the valves to impair the flow.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.Even small amounts of non-visible deposits might be compromise the integrity of the valves.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.

Event Description

Additional information and the product for investigation are available.Patient height: 75 cm.

• Brand Name: PROGAV 2.0 SYS PED.W/SA20 A.PRECHAMBER
• Type of Device: HYDROCEPHALUS MANAGEMENT
• Manufacturer (Section D): CHRISTOPH MIETHKE GMBH & CO KG; ulanenweg 2; potsdam, 14469 ; GM 14469
• MDR Report Key: 10393134
• MDR Text Key: 202533573
• Report Number: 3004721439-2020-00156
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• PMA/PMN Number: K161853
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 08/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/22/2023
• Device Model Number: FX441T
• Device Catalogue Number: FX441T
• Device Lot Number: 20037867
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/13/2020
• Date Manufacturer Received: 08/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 22 MO
• Patient Weight: 7