MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG PROGAV W/SHUNTASSIST.20 + DIST.CATH.; HYDROCEPHALUS MANAGEMENT

Model Number	FV420T
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	11/11/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This complaint was reopened in reference to (b)(4).Investigation: we received the valve in a plastic container.The valve was inserted in an unknown liquid.The progav was set to pressure range 8 cmh2o at the time of delivery.Optical inspection: first step of our investigation is the optical inspection.The visual inspection revealed that the valve has no apparent deformations or other abnormalities.However, the measurement of parallelism has shown, with a measured value of -0,0715 mm, that the valve is outside the accepted tolerance.Result: in the visual inspection of the valve, we could not detect any apparent damage.Nevertheless, the measurement of the parallelism could confirm a deformation.In the further course of investigation we carried out a permeability test.The investigation has resulted that the valve was permeable.However, it was not possible to adjust the valve.To proof if the brake function is full in place, despite the deformation observed, we carried out a brake function test.The investigation has shown that the brake function is present, but it was not possible to measure the braking force due to the non-adjustability.In order to verify whether the valve examined here has been influenced by the known risks of hydrocephalus therapy, for example by natural substances in the cerebrospinal fluid (protein, blood or tissue particles), we have finally decided to dismantle the valve.Inside the progav-valve we have found apparent deposits or substances of protein which might could be the reason for the assumed difficulties in adjustability in the past.Based on our investigation results we can confirm that it was not possible to adjust the progav valve.This is presumably due to the found deposits inside the valve and probably less due to the fact that the valve is deformed.But at the time of delivery there is no failure detectable with this progav valve.No further actions required.
Event or Problem Description
According to the complainant a progav had a malfunction postoperatively.The patient was originally implanted on (b)(6) 2013.Readjustment was not possible.The revision date was (b)(6) 2016.The valve was explanted and returned to the manufacturer for evaluation.Further details were not provided.Height:(b)(6).

• Brand Name: PROGAV W/SHUNTASSIST.20 + DIST.CATH.
• Common Device Name: HYDROCEPHALUS MANAGEMENT
• Manufacturer (Section D): CHRISTOPH MIETHKE GMBH & CO KG; ulanenweg 2; potsdam, 14469 ; GM 14469
• MDR Report Key: 12540360
• Report Number: 3004721439-2021-00671
• Device Sequence Number: 4584697
• Product Code: JXG
• UDI-Device Identifier: 04041906132170
• UDI-Public: 4041906132170
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K141687
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2016
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/27/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2017
• Device Model Number: FV420T
• Device Catalogue Number: FV420T
• Device Lot Number: 20017996
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/24/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/18/2016
• Initial Report FDA Received Date: 09/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 4 YR
• Patient Weight: 14