MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO. KG PROSA W/ADJ.DIFFERENTIAL PRESSURE UNIT; PREVIOUSLY REPORTED

Model Number FV782T

Device Problems Defective Device (2588); Application Program Problem (2880); Therapeutic or Diagnostic Output Failure (3023)

Patient Problem No Code Available (3191)

Event Date 12/16/2019

Event Type  Injury  

Manufacturer Narrative

Additional information / investigation results will be provided in a supplemental report, if applicable.

Event Description

It was reported that there was an issue with the shunt system.The patient was initially implanted with a prosa valve with adjustable differential pressure unit on an unspecified date.On (b)(6) 2020, there was difficulty in programming; the setting could not be changed.The patient was seen on (b)(6) 2020 in the neurosurgery clinic.The clinical application specialist was present and used the sales consultant's progav programming kit and tried multiple times to adjust the setting.However, the valve would not adjust and it was noted that it may be due to the valve being "gummed up".There was a revision surgery to replace the defective valve on (b)(6) 2020.It was noted that the patient outcome was good after the revision surgery; the valve was approximately 6 years old.Additional information has been requested.

Event Description

No update received.

Manufacturer Narrative

Manufacturing and quality control data : the prosa was manufactured by a qualified employee in july 2014 and the progav valve employee in october 2013.Deviations during assembly did not occur.The valves were sterilized by miethke and released for shipment after final inspection.For the purposes of this investigation, the prosa shunt system is comprised of a prosa adjustable valve and a progav adjustable valve.The prosa valve has a normal pressure range of 0 to 40 cmws.The progav has a normal pressure range of 0 to 20 cmws.The prosa was inspected as article fv701t and the progav as article fv410t.All parameters (opening pressure, reflux, leak-proof/integrity of housing, adjustability and brake function) have been inspected and approved during the manufacturing process.All parameters have been assessed as meeting specifications.Before release, the prosa valve was pre- adjusted to a pressure setting of 20 cmh2o and the progav valve was pre-adjusted to a pressure setting of 5 cmh2o.Investigation: description of incoming product condition.The shunt system was received submersed in an unidentified liquid in plastic container.At the time of intake, the prosa valve was at a pressure setting of 15 cmh2o and the progav valve was at a pressure setting of 5,5 cmh2o.Visual inspection : in the first step of our investigations an optical control is carried out.It is checked whether any defects, deformations or other noticeable irregularities can be identified.The visual inspection revealed deposits on the valves but no significant deformation or damage.Permeability test : to check whether the system is blocked, a permeability test is carried out on the both valves.This test is carried out at a calculated hydrostatic height (opening pressure of both valves added together plus 30 cmh2o) in the horizontal flow direction.Adjustment test : our adjustment tests are carried out with the standard progav and prosa check-mate and measurement tool.The prosa valve is adjusted from 0 to 40 cmh2o and down again in increments of 4 cmh2o.The progav valve is adjusted from 0 to 20 cmh2o and down again in increments of 5 cmh2o.Braking force and brake function test : to measure the braking force, we tested the prosa and the progav valve with a braking force apparatus.Here it is measured how much force must be exerted on the housing to release the rotor to adjust the valve by the integrated magnet of the braking force apparatus.Results : next we tested the permeability of the shunt system.The test results show that both valves are permeable.To ensure that the valves are adjustable we tried to adjust the prosa valve from 0 cmh2o to 40 cmh2o and down again in increments of 4 cmh2o and the progav valve from 0 cmh2o to 20 cmh2o and down again in increments of 5 cmh2o.The prosa valve was not adjustable to specifications and the progav was adjustable to all settings.Next we tested the braking force and brake functionality.The results show that the progav valve the brake function is fully operational and the braking force is within the given tolerances.The brake function at the prosa is operational, however the braking force cannot be measured due to the non-adjustability of the valve.In order to verify whether the valves were compromised by the known risks of hydrocephalus therapy, e.G.By a build-up of natural substances (protein, blood or tissue particles)1 ,2 in the cerebrospinal fluid, we have dismantled the valves.Inside both valves we have found build-up of substances (likely protein), which may have caused the suspected malfunction.Based on our investigation, we confirm the prosa valve was non-adjustable, likely due to build-up of protein deposits.The progav operates within the specified tolerances.As described in scientific literature, the problem encountered is one of the known, inevitable risks of hc-therapy by shunt implants.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.Further actions : no further regulatory actions are required from our point of view.

• Brand Name: PROSA W/ADJ.DIFFERENTIAL PRESSURE UNIT
• Type of Device: PREVIOUSLY REPORTED
• Manufacturer (Section D): CHRISTOPH MIETHKE GMBH & CO. KG; 2 ulanenweg; potsdam, 14469 ; GM 14469
• MDR Report Key: 9746451
• MDR Text Key: 180709974
• Report Number: 2916714-2020-00043
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Type of Report: Initial,Followup
• Report Date: 03/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FV782T
• Device Catalogue Number: FV782T
• Device Lot Number: L14985G436
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2020
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/05/2020
• Event Location: Hospital
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention