MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO. KG PROGAV SYS W/SA 20 A.CONTROL RESERVOIR; HYDROCEPHALUS VALVES

Model Number FV434T

Device Problem Obstruction of Flow (2423)

Patient Problem Hydrocephalus (3272)

Event Date 11/12/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Patient information: unknown (age, sex, weight, height).When additional information is received a follow up report will be submitted.

Event Description

It was reported that the patient underwent the ventriculoperitoneal shunt for the first time in (b)(6) 2018.After the operation, the patient was transferred to the rehabilitation hospital for further rehabilitation.The patient was admitted to the hospital for further treatment on (b)(6) 2018.After clinical examination and confirmation, it was discovered it is due to the blockage of the valve.The tube needs to be replaced.The patient underwent revision surgery of hydrocephalus on (b)(6).Fv434-t was used to shunt excess cerebrospinal fluid, restore normal intracerebral pressure and reduce excessive drainage.Additional patient information has been requested.When additional information is received a follow up report will be submitted.All med watch submissions related to this event: 3004721439-2018-00301.

Manufacturer Narrative

Manufacturing evaluation: we received the permission for investigation on (b)(6) 2019.With the release of this report the investigation is closed.Manufacturing and quality control data - the progav shunt system was manufactured by a qualified employee in (b)(6) 2017.Deviations during assembly did not occur.The system was sterilized by miethke and released for shipment after final inspection.The progav valve has a normal pressure range of 0 to 20 cmws and the shunt assistant has a normal pressure setting of 20 cmws.Investigation - description of incoming product condition- the shunt system was received dry (not submersed in liquid as suggested) visual inspection - a slightly deformation of the outer housing of the progav valve was observed through the visual inspection.The measurement of the plane parallelism verified a deformation.The progav valve is, with -0.06 mm, outside the permissible tolerance (tol.0 +/- 0.02 mm).Permeability test - to proof the penetrability of the valves we have carried out penetrability tests.These tests are carried out at a hydrostatic pressure of approximately 20-30 cmh2o in the direction of flow.The test results show that both valves are not permeable.Adjustment test - our adjustment tests are carried out with the standard progav check-mate and measurement tool.The progav valve is adjusted from 0 to 20 cmh2o and down again in increments of 5 cmh2o.The valve was not fully adjustable to specifications.An adjustment test by the shuntassistant is not applicable, because the valve has a fixed pressure.Braking force and brake function test - to measure the braking force, we tested 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.The investigation of the braking force showed the brake function is operational, however the braking force cannot be measured due to the non-adjustability of the valve.And a braking force and a brake function test by the shuntassistant is not applicable, because the valve has a fixed pressure.Results - it should be noted that the progav shunt system was received dry (i.E.Not submersed in liquid as recommended).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 have investigated the valves to the best of our abilities.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 in the cerebrospinal fluid, we have dismantled the valves.Inside both valves we have found dry substances (likely protein), which may have caused the suspected malfunction in the past.Based on our investigations, we can confirm a blockage of the valves at the time of examination.Additionally the progav is not adjustable, likely due to build- up of protein and blood desposits.As described in our 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 shuntassistant met all specifications of the final inspection when released from christoph miethke gmbh & co.Kg.

• Brand Name: PROGAV SYS W/SA 20 A.CONTROL RESERVOIR
• Type of Device: HYDROCEPHALUS VALVES
• Manufacturer (Section D): CHRISTOPH MIETHKE GMBH & CO. KG; 2 ulanenweg; potsdam d, 14469 ; GM 14469
• MDR Report Key: 8152951
• MDR Text Key: 129980892
• Report Number: 3004721439-2018-00306
• 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: 10/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2022
• Device Model Number: FV434T
• Device Catalogue Number: FV434T
• Device Lot Number: 20035506
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2018
• Distributor Facility Aware Date: 12/06/2018
• Device Age: 1 YR
• Date Manufacturer Received: 04/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention