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

Model Number FV433T

Device Problem Overcorrection (3006)

Patient Problem Hydrocephalus (3272)

Event Date 05/03/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Manufacturing site evaluation: evaluation on-going.Date of explant: unknown.Pending further information.

Event Description

It was reported by the healthcare professional to the company sales representative "patient was operated by 'hyperdrenagem' of the previous system.Shunt was implanted with fit 15 and the patient developed hydrocephalus.It was not possible to adjust the pressure subsequently when the patient developed hydrocephalus.The patient underwent further surgery and prolonged hospitalization.

Manufacturer Narrative

Manufacturing and quality control data: the progav valve was manufactured by a qualified employee in august 2017.Deviations during assembly did not occur.The valve was sterilized by miethke and released for shipment after final inspection.All parameters have been assessed as meeting specification.Visual inspection: no significant deformations or damage of the valve were detected during the visual inspection.Permeability test: a permeability test has shown that the progav valve is permeable.Adjustment test: the progav valve was tested and is adjustable to all specified pressures.Braking force and brake function test: the brake functionality test has shown that the brake function is fully operational and the braking force is within the given tolerances.Results: finally we have dismantled the valve.Inside the progav valve we have found a slight build up of substances (likely protein).Based on our investigation, we are unable to substantiate the claim of non-adjustability.The valve operates within the specified tolerances.However, it is possible that the deposits observed inside the valve could have caused the malfunction in the past.As described in our literature, the problem encountered is one of the known, inevitable risks of hc therapy by shunt implants.No capa is necessary.

• Brand Name: PROGAV SYS W/SA 15 A.CONTROL RESERVOIR
• Type of Device: HYDROCEPHALUS VALVES
• Manufacturer (Section D): CHRISTOPH MIETHKE GMBH & CO. KG; 2 ulanenweg; potsdam, D-144 69; GM D-14469
• MDR Report Key: 7834437
• MDR Text Key: 118820598
• Report Number: 3004721439-2018-00211
• 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: 11/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/28/2022
• Device Model Number: FV433T
• Device Catalogue Number: FV433T
• Device Lot Number: 20034957
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/01/2018
• Distributor Facility Aware Date: 08/23/2018
• Device Age: 1 YR
• Date Manufacturer Received: 11/06/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 15 YR