MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO. KG PROSA VALVE W/DIST.CATHETER; HYDROCEPHALUS MANAGEMENT

Model Number FV706T

Device Problem Infusion or Flow Problem (2964)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 01/09/2020

Event Type  Injury  

Manufacturer Narrative

Height: 160cm.Implant date: 2013 (unknown month and day).When additional information becomes available a follow up report will be submitted.

Event Description

It was reported the valve was not adjustable.The reporter indicated that an approximately 6 year old post-operative valve was not able to be adjusted and required explantation.Additional information was not provided.

Manufacturer Narrative

Investigation.Visual inspection: no significant deformations or damage of the valves were detected during the visual inspection.The progav valve housing was subsequently measured and indicated the presence of a slight deformation.The housing deformation measured at -0.068mm, outside the tolerance of 0 +/- 0.02mm.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.However, the braking force required is not within the specified tolerances.Computer controlled test: to investigate the claim of malfunction, the opening pressure is measured using a miethke computer controlled testing apparatus, which simulates a cerebrospinal fluid flow.The progav valve is operating within acceptable tolerances.Finally, we have dismantled the valves.There were no visible deposits observed inside the valve.Based on our investigation, we are unable to substantiate the claim of malfunction.At the time of our investigation, the progav valve operated as expected, but due to the reduced braking force, it could have temporarily led to an unintentional and spontaneous adjustment of the valve.In addition, it is possible that the deposits observed inside the valve could have caused the malfunction in the past, too.As described in our literature, the problem encountered is one of the known, inevitable risks of hc-therapy by shunt implants.The cause of the deformation of the progav valve and the resultant reduced braking force could not be determined through our investigation.However, we would like to point out that significant outside pressure, for example by too much force from the progav adjustment tool or by a fall or impact to the head of the patient, can compromise the integrity of the valve.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.

• Brand Name: PROSA VALVE W/DIST.CATHETER
• Type of Device: HYDROCEPHALUS MANAGEMENT
• Manufacturer (Section D): CHRISTOPH MIETHKE GMBH & CO. KG; 2 ulanenweg; potsdam d, 14469 ; GM 14469
• MDR Report Key: 9597761
• MDR Text Key: 187269840
• Report Number: 3004721439-2020-00019
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• PMA/PMN Number: K120559
• 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: 02/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/16/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/16/2016
• Device Model Number: FV706T
• Device Catalogue Number: FV706T
• Device Lot Number: 20015568
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2020
• Date Manufacturer Received: 01/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 29 YR
• Patient Weight: 90