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

Model Number	FV414T
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	11/03/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This complaint was reopened in reference to (b)(4).Investigation: the valve was received submersed in an unidentified liquid in the provided return kit.Visual inspection: no significant deformations or damage of the valve were detected during the visual inspection.Result: first, we performed a visual inspection of the progav.No significant deformations or damage of the valve were detected during the visual inspection.This was confirmed through a measurement of the plane parallelity.Next, we tested the permeability, adjustability,as well as the brake functionality and brake force.The valve operates as expected and met all specifications except that the first measurement of the opening pressure was out of tolerance.Whereas the second measurement was within.We assume that deposits were flushed out through the measurements.Finally, we have dismantled the valve.Inside the valve we have found a build-up of substances (likely protein).Based on our investigation, we confirm that the valve shows a slower flow of liquid at the time of our investigation.This is likely due to the deposits observed inside the valves.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 gmbh & co.Kg.No further actions required.
Event or Problem Description
According to the complainant a progav was suspected of postoperative blockage.The patient was originally implanted in 2010.The revision date was (b)(6) 2016.The valve was explanted and returned to the manufacturer for evaluation.Further details were not provided.Height: 126 cm.

• Brand Name: PROGAV WITH SHUNTASSISTANT 25
• Common Device Name: HYDROCEPHALUS MANAGEMENT
• Manufacturer (Section D): CHRISTOPH MIETHKE GMBH & CO KG; ulanenweg 2; potsdam, 14469 ; GM 14469
• MDR Report Key: 12506399
• Report Number: 3004721439-2021-00655
• Device Sequence Number: 5169016
• Product Code: JXG
• UDI-Device Identifier: 04041906137298
• UDI-Public: 4041906137298
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K062009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2016
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/20/2021

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 Model Number: FV414T
• Device Catalogue Number: FV414T
• Device Lot Number: 20009851
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/04/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/09/2016
• Initial Report FDA Received Date: 09/21/2021
• 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: 16 YR
• Patient Weight: 33