MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG PROGAV SYSTEM PED.WITH PRECHAMBER; HYDROCEPHALUS MANAGEMENT

Model Number FV438T

Device Problem Mechanical Problem (1384)

Patient Problems Patient Problem/Medical Problem (2688); Hydrocephalus (3272)

Event Date 05/28/2020

Event Type  Injury  

Manufacturer Narrative

Additional information will be provided when the product is returned for investigation and has been investigated in a follow-up report.

Event Description

It was reported that there was a problem with a progav valve.The problem - adjustment inability of a programmable element (inability to change the shunt pressure).Patient data - (b)(6) year (age), (b)(6) kg (approx.Weight), 122 cm (approx.Height).Initial setting 5cm h20 was kept after implantation.4 years later - symptoms of the underdrainage were gradually appearing.Valve setting could not be changed.Implantation date - (b)(6) 2015.Removal date - (b)(6) 2020.Complete miethke shunt system was implanted.

Manufacturer Narrative

New informations are available: d10 was updated.Patient information age: 5 years, weight: 16 kg, height: 122 cm, gender: unknown, date of implantation: on (b)(6) 2015, date of removal: on (b)(6) 2020, diagnosis according to the questionnaire: unknown.Description of product upon intake.The valve was received submersed in an unidentified liquid in the provided return kit.The following products were submitted for return: progav®, pediatric prechamber, shuntassistant®.Opening pressure upon intake.At the time of intake, the progav® showed a pressure setting of 4, 5 cmh2o.Investigation: the following section describes, in detail, the method and the results of the investigation.Visual inspection: in the first step of our investigation, we performed a visual inspection of the product.We have checked for possible damages, deformations of the housing or other abnormalities.The following observations were made during the visual inspection: except for visible deposits both inside and outside the pediatric prechamber, no defects could be detected.Measurement of surface of the housing.To verify if a deformation (visible or not visible) had an effect on the plane-parallelism of the housing surface, this was measured using a dial gauge.Despite the fact that no visible deformation was detected in the optical test, the measurement of the plane-parallelism shows that the housing membrane is out of tolerance with a value of -0.0490 mm (tol.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: to check if the progav® system ped.With prechamber and shuntassistant® is blocked, we have performed a permeability test on the system.This test is carried out with the product in the horizontal position with a hydrostatic pressure difference of approx.30 cmh2o in the direction of flow.The test showed that the progav® system ped.With prechamber and shuntassistant® is permeable.Computer controlled test: in order to investigate the suspicion of underdrainage the progav® and shuntassistant® was tested on a miethke computer controlled testing apparatus.The valves weretested by simulating a cerebrospinal fluid flow at rates from 60 ml / hr down to 5 ml / hr with the valve in horizontal and vertical position (in accordance with iso 7197).Distilled water was used as the test-liquid.The resulting opening pressure was measured.The computer controlled test has shown the opening pressure of the progav®, at a reference flow rate of 20 ml / hr in a horizontal position, to be 1.34 cmh2o.This is not within the specified tolerance of 4,5 cmh2o ± 3 cmh2o.Additional testing did not significantly change the results.According to our results, we can confirm the presence of an overdrainage.Additionally, the shuntassistant® was tested according to standard procedure in the vertical position.At a fixed opening pressure of 20 cmh2o in the vertical position, a pressure of 18 cmh2o to 24 cmh2o is expected.The results indicated that at a reference flow of 20 ml/hr in the vertical position, the shuntassistant® had a pressure of 17.39 cmh2o.This is not within the specified tolerance.A further test could improve the measured value.The valve now works within the permissible tolerance.Adjustability test: we have investigated whether the progav® can be successfully set to each specified pressure setting.Thus indicating whether the valve(s) are fully adjustable within the full range of specified pressure settings ( in increments of 5 cmh2o).The progav® was found to be not fully adjustable to specifications.Braking force and brake function test: the braking force and brake function test investigates whether the braking function of the adjustable valve(s) is present and how much force must be exerted on the housing to release the rotor to adjust the valve(s) using the integrated magnet of a specific measurement apparatus of braking force.The braking force test indicates that the brake function of the progav® is present.Due to the non-adjustability of the valve, as detailed in section 7.4, an investigation of the braking force was not possible.Internal inspection of product: in order to verify whether the investigated valve 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 valve.After dismantling of the valves, clearly deposits were found inside progav® and shuntassistant®.Results: based on our investigation, we are able to substantiate the claim of "non- adjustability" and contrary to the presumed underdrainage, we can confirm an overdrainage at the progav®.We can exclude a blockage of the valves, see "permeability test".We are assuming that the deposits detected within the valve 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.We can exclude a defect at the time of release.The products 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.

Event Description

The product was sent to us for examination on (b)(6) 2020.The investigation is done.

• Brand Name: PROGAV SYSTEM PED.WITH PRECHAMBER
• Type of Device: HYDROCEPHALUS MANAGEMENT
• Manufacturer (Section D): CHRISTOPH MIETHKE GMBH & CO KG; ulanenweg 2; potsdam, 14469 ; GM 14469
• MDR Report Key: 10239356
• MDR Text Key: 197929947
• Report Number: 3004721439-2020-00134
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• PMA/PMN Number: K103003
• 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: 08/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/16/2019
• Device Model Number: FV438T
• Device Catalogue Number: FV438T
• Device Lot Number: 20023785
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/25/2020
• Date Manufacturer Received: 08/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 5 YR
• Patient Weight: 16