MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG GAV 2.0 SYST WITH SPRUNG RES.5/30; HYDROCEPHALUS MANAGEMENT

Model Number	FX272T
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	10/05/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation: visual inspection: no significant deformations or damage of the valve were detected during the visual inspection.Dry and bloody residues on the inlet spout are visible.Permeability test: a permeability test has shown that the valve is difficult permeable.Computer controlled test: to investigate the claim of under-drainage, the opening pressure is measured using a miethke computer controlled testing apparatus which simulates a cerebrospinal fluid flow.The valve is tested in both the horizontal as well as the vertical positions.The results show that the valve is operating within the accepted tolerance in the vertical but not in the horizontal position.Results: it should be noted that the valve was received dry (i.E.Not submersed in liquid as recommended).The investigation of dry items is not significant due to the affect dry deposits of liquor and blood can have on product performance.In spite of this, we have investigated the valve to the best of our abilities.First, we performed a visual inspection of the gav 2.0.No significant deformations or damage of the valve were detected during the visual inspection.Next, we tested the permeability of the valve.The valve was shown to be permeable.Then we carried out a computer controlled simulated flow test.The measured opening pressure was within the accepted tolerance in the vertical position but not in the horizontal position.The opening pressure was significantly higher than expected in the horizontal position, indicating a tendency towards under-drainage.Finally, we have dismantled the valve.Inside the valve we have found a build-up of substances (likely protein) in the inlet spout.Based on our investigation, we confirm that the valve is operating in an under-drainage state, likely due to the deposits observed inside the valve.As described in scientific literature, the problem encountered is one of the known, inevitable risks of hc-therapy by shunt implants.We can exclude a defect at the time of release.The valve met all specifications of the final inspection when released from christoph miethke (b)(4).No further regulatory actions are required from our point of view.
Event or Problem Description
It as reported that there was an blockage/under-drainage problem with a gav 2.0 valve.Patient information: age: (b)(6) years.Weight: (b)(6) kg.Height: 164 cm.Gender: unknown.Date of implantation: (b)(6) 2020.Date of removal: (b)(6) 2020.

• Brand Name: GAV 2.0 SYST WITH SPRUNG RES.5/30
• Common Device Name: HYDROCEPHALUS MANAGEMENT
• Manufacturer (Section D): CHRISTOPH MIETHKE GMBH & CO KG; ulanenweg 2; potsdam, 14469 ; GM 14469
• MDR Report Key: 10726266
• Report Number: 3004721439-2020-00218
• Device Sequence Number: 13921338
• Product Code: JXG
• UDI-Device Identifier: 04041906500801
• UDI-Public: 04041906500801
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K190174
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/19/2020

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: 10/27/2024
• Device Model Number: FX272T
• Device Catalogue Number: FX272T
• Device Lot Number: 20044639
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/07/2020
• Initial Report FDA Received Date: 10/23/2020
• 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: 59 YR
• Patient Weight: 66