MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO. KG PROGAV 2.0 SYS PED.W/SA25 A.PRECHAMBER; HYDROCEPHALUS VALVES

Model Number FX442T

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

Patient Problem Failure of Implant (1924)

Event Date 11/09/2018

Event Type  malfunction  

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,"10m po valve is blocked.Explanted.".

Manufacturer Narrative

Investigation: visual inspection: a deformation of the outer housing of the progav 2.0 valve was observed through the visual inspection.No significant deformations or damage of the shunt assistant valve was detected.Permeability test: a permeability test has indicated that the shunt assistant has a blockage and the progav 2.0 valve is 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 braking force is within the given tolerances.Results: finally, we have dismantled the valves.Inside the progav 2.0 valve we found slight visible deposits (likely protein).No visible deposits were observed inside the shunt assistant valve.Based on our investigation, we confirm the presence of occlusion in the shunt assistant valve.Even a small amount of non-visible blood protein can lead to temporary blockage and could be responsible for the suspected malfunction.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/SA25 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: 8148971
• MDR Text Key: 129873245
• Report Number: 3004721439-2018-00291
• 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: 03/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/05/2022
• Device Model Number: FX442T
• Device Catalogue Number: FX442T
• Device Lot Number: 20034174
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2018
• Distributor Facility Aware Date: 02/25/2019
• Device Age: 1 YR
• Initial Date Manufacturer Received: 11/19/2018
• Initial Date FDA Received: 12/10/2018
• Supplement Dates Manufacturer Received: 02/25/2019
• Supplement Dates FDA Received: 03/11/2019
• 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: 20