MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO. KG PROGAV SYS PED.W/SA 15 A.PRECHAMBER; HYDROCEPHALUS VALVES

Model Number FV440T

Device Problem Obstruction of Flow (2423)

Patient Problem Failure of Implant (1924)

Event Type  Injury  

Manufacturer Narrative

(b)(4).When additional information is received a follow up report will be submitted.

Event Description

It was reported by the healthcare professional "after implanted for a period of time, the patient was checked back into the hospital for pressure adjustment.But it was found unable to adjust the pressure.The valve pressure data was maintained with the same as last time.The device was explanted.".

Manufacturer Narrative

The shunt system was received dry in a plastic bag.At the time of submission the progav valve was set to pressure setting of 3 cmh2o.The first step of our investigation is an optical inspection.We found scratches on the valve housing but did not detect any obvious deformations or other abnormalities.However, the measurement of the plane parallelism could detect a deformation, the valve is with -0.0330 mm slight outside the permissible tolerance (tol.0+/- 0.02mm).Deformations can impair the functionality of the brake function and also the adjustability of the valve.To proof the penetrability of the valve we have carried out a penetrability test.This test was carried out at a hydrostatic pressure of approximately 20-30 cmh2o in the direction of flow.The investigation has shown that the progav valve was not permeable.Our adjustment tests are carried out with the standard progav check mate and measurement tool.The valve is adjusted from 0 up to 20 cmh2o and down again in increments of 5cmh2o.It was found that it was not possible to adjust the valve to the specified pressures settings.To measure the braking force we have investigated the valve with a braking force apparatus.Here is the measured how much force must be exerted on the housing of the progav 2.0 valve to release the rotor to adjust the valve by the integrated magnets.The brake function could be proven correctly.However, the measurement of the braking force could not be investigated because it was not possible to adjust the valve.We want to point out that we received the valve dry.The investigation of dry items is not significant due to the affect dry deposits of liquor and blood can have on product performance.In spite of this, we still decided to investigate the valve in all possible manner as best as we can.In the visual inspection of the progav valve we could find has scratches but not deformation or abnormalities.However, the measurement of parallelism has found a deformation of the housing membrane.Next we tested the permeability of the valve.The investigation indicated that the valve was not permeable.To ensure the valve is adjust the valve from 0 cmh20 up to 20cmh2o and down again in the same way in steps of 5 cmh2o.It was not possible to adjust the valve from 0 up to 20 cmh2o.To proof if the brake function is full in place we carried out a brake function test.However, the measurement of the braking force could not be investigated because it was not possible to adjust the valve.In order to verify whether the valve was compromised by the known risks of hydrocephalus therapy , e.G.By the build-up of natural substances (protein, blood or tissue particles) in the cerebrospinal fluid, we have dismantled the valve.As expected, inside the valve we have found significant dried substances (likely protein).Based on the investigation result we can confirm that the valve was not adjustable.We suspect that the substantial dried deposits in the valve may have affected the functioning of the valve.At the time of the distribution there is no failure detectable with the valve.

• Brand Name: PROGAV SYS PED.W/SA 15 A.PRECHAMBER
• Type of Device: HYDROCEPHALUS VALVES
• Manufacturer (Section D): CHRISTOPH MIETHKE GMBH & CO. KG; 2 ulanenweg; potsdam d, 14469 ; GM 14469
• MDR Report Key: 8117217
• MDR Text Key: 128856782
• Report Number: 3004721439-2018-00284
• 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: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 01/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2020
• Device Model Number: FV440T
• Device Catalogue Number: FV440T
• Device Lot Number: 20027699
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2018
• Distributor Facility Aware Date: 12/11/2018
• Device Age: 3 YR
• Date Manufacturer Received: 12/11/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention