MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO. KG PROGAV SYS PED.W/SA 25 A.BURRH.RES.; HYDROCEPHALUS VALVES

Model Number FV449T

Device Problem Infusion or Flow Problem (2964)

Patient Problems Failure of Implant (1924); Hydrocephalus (3272)

Event Date 10/30/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Manufacturing site evaluation: investigation on-going.Additional information / investigation results will be provided in a supplemental report.

Event Description

It was reported that a progav shunt system was explanted due to a malfunction.A (b)(6) patient underwent a shunt system implantation on (b)(6) 2018.After 16 days, it was noted that the valve adjusted on its own.This issue led to explantation of the device.Further details have been requested but not yet received.

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 valve were observed through the visual inspection.No significant deformations or damages were detected.The progav housing was subsequently measured and confirmed the plan parallelity of the valve housing.Permeability test: a permeability test has shown that the progav is permeable.Adjustment test: the progav 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 operates as expected.However, the braking force required was not within the given specification.Results: we have dismantled the valve.There were no visible deposits inside the valve.Based on our investigation, we are unable to substantiate the claim of self-adjusting.The valve operated as expected, albeit with a reduced braking force, and was adjustable to all settings.It is possible that the reduced braking force could have resulted in the valve being adjusted inadvertently in the past.The cause of the reduced braking force could not be determined through our investigation.Significant outside pressure, for example, using 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.

• Brand Name: PROGAV SYS PED.W/SA 25 A.BURRH.RES.
• Type of Device: HYDROCEPHALUS VALVES
• Manufacturer (Section D): CHRISTOPH MIETHKE GMBH & CO. KG; 2 ulanenweg; potsdam d, 14469 ; GM 14469
• MDR Report Key: 8126731
• MDR Text Key: 129147613
• Report Number: 3004721439-2018-00285
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 12/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2019
• Device Model Number: FV449T
• Device Catalogue Number: FV449T
• Device Lot Number: 81895219
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2018
• Distributor Facility Aware Date: 11/26/2018
• Device Age: 44 MO
• Date Manufacturer Received: 11/29/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 3 MO
• Patient Weight: 2