MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO. KG PROGAV WITH SHUNTASSISTANT 25; HYDROCEPHALUS VALVES

Model Number FV414T

Device Problem Obstruction of Flow (2423)

Patient Problem Failure of Implant (1924)

Event Date 10/18/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Height (cm): 137.Implant date: (b)(6) 2008 (day unknown).When additional information is received a follow up report will be submitted.

Event Description

It was reported by the healthcare professional "4m po valve is not adjustable.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.Inspection: visual inspection: a deformation of the outer housing of the progav was observed through the visual inspection.No deformation or damage of the shunt assistant was observed.The progav housing was subsequently measured and confirmed the presence of a deformation.The housing deformation measured at 0.1470mm, outside the tolerance of 0 +/- 0.02mm.Permeability test: a permeability test has indicated that the shunt assistant has a blockage and the progav is permeable.Adjustment test: the progav was tested and is not adjustable throughout the normal range.The valve was found to be non-adjustable in the lower range between 0-8 cmh2o, but fully adjustable in the upper range, between 8-20 cmh2o.Braking force and brake function test: the brake functionality test has shown that the brake function operates as expected.However, the breaking force was not able to be measured due to the non-adjustablilty of the progav.Results: we have dismantled the valves.Inside both valves we have found a build-up of substances (likely protein).Based on our investigation, we can confirm that the progav is non-adjustable and the shunt assistant valve is occluded, both likely due to the deposits observed inside the valves.As described in our literature, the problems encountered are of the known, inevitable risks of hc-therepy by shunt implants.

• Brand Name: PROGAV WITH SHUNTASSISTANT 25
• Type of Device: HYDROCEPHALUS VALVES
• Manufacturer (Section D): CHRISTOPH MIETHKE GMBH & CO. KG; 2 ulanenweg; potsdam d, 14469 ; GM 14469
• MDR Report Key: 8080334
• MDR Text Key: 127443442
• Report Number: 3004721439-2018-00276
• 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: 12/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2013
• Device Model Number: FV414T
• Device Catalogue Number: FV414T
• Device Lot Number: 4501454259
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2018
• Distributor Facility Aware Date: 10/29/2018
• Device Age: 10 YR
• 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: 11 YR
• Patient Weight: 30