MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO. KG PROGAV 2.0 SYS PED.W/SA20 A.BURRHOLE RES; HYDROCEPHALUS VALVES

Model Number FX448T

Device Problems Obstruction of Flow (2423); Blocked Connection (2888)

Patient Problem Failure of Implant (1924)

Event Date 11/12/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Patient information: unknown (height and gender).When additional information is received a follow up report will be submitted.

Event Description

It was reported by the healthcare professional,"3y po valve is blocked.Explanted.".

Manufacturer Narrative

Manufacturing and quality control data: all parameters have been inspected and approved during the manufacturing process.All parameters have been assessed as meeting specifications.Investigation: visual inspection: scratches on the outer housing of the valves were observed through the visual inspection.No significant deformations or damages were detected.Permeability test: a permeability test has shown that both valves are permeable adjustment test: the progav 2.0 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.Computer controlled test: to test the opening pressure, we use a miethke computer controlled testing apparatus, which simulates a cerebrospinal fluid flow.The tests have shown that both valves are operating within acceptable tolerances.Results: we have dismantled the valve.Inside both valves we have found significant build up of substances (likely protein).Based on our investigation, we are unable to substantiate the claim of occlusion or of underdrainage.The valves operate within the specified tolerances.However it is possible that the deposits observed inside the valves could have temporarily caused the malfunction if the past.As described in our literature, the problem encountered is one of the known inevitable risks of hc-therapy by shunt implants.

• Brand Name: PROGAV 2.0 SYS PED.W/SA20 A.BURRHOLE RES
• Type of Device: HYDROCEPHALUS VALVES
• Manufacturer (Section D): CHRISTOPH MIETHKE GMBH & CO. KG; 2 ulanenweg; potsdam d, 14469 ; GM 14469
• MDR Report Key: 8152947
• MDR Text Key: 129980899
• Report Number: 3004721439-2018-00292
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• PMA/PMN Number: K161853
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 12/27/2018

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: 06/30/2020
• Device Model Number: FX448T
• Device Catalogue Number: FX448T
• Device Lot Number: 20027305
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2018
• 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
• Patient Age: 3 YR
• Patient Weight: 11