MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG PROGAV VALVE; HYDROCEPHALUS MANAGEMENT

Model Number	FV410T
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Hydrocephalus (3272)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This complaint was reopened in reference to (b)(4).Manufacturing site evaluation: manufacturing and quality control data the valve was manufactured by a qualified employee in september 2014.Deviations during assembly did not occur.The valve was sterilized by miethke and released for shipment after final inspection.The valve has a nominal pressure rating of 0 to 20 cmws.The valve specifications after closing the valve for 5 ml/h or 50 ml/h flow for a set presure range of 0, 10, 20 cmh20 were fine.The valve was inspected as article fv410t.All parameters of the valve (opening pressure, reflux, tightness, adjustability, and brake function) have been inspected and signed during the manufacturing process.All parameters have been assessed as meeting specification.Before release the progav was pre-adjusted to presure setting 5 cmh20.Device examination: the prgav® valve was returned submersed in an unidentified liquid in the provided returnkit.The progav was set to pressure range 6 cmh20 at the time of receipt.Visual inspection: a visual inspection was performed which revealed no deformations or other abnormalities.However, a measurement of the plane parallelism revealed a slight deformation.Permeability test: a permeability test has shown that the valve was permeable with difficulty.Adjustment test: the valve was tested and was not able to be adjusted.Braking force and brake function test: the brake functionality and braking force tests were not able to be performed as the valve was not able to be adjusted.Result: first, a visual inspection of the valve was performed.No deformations or other abnormalities.However, a measurement of the plane parallelism revealed a slight deformation.Next, the permeability, adjustability, as well as the brake functionally and brake force, of the valve were tested.The valve was permeable with difficulty.The valve was not able to be adjusted so the brake functionality and braking force tests were not able to be performed.Finally, the valve was dismantled.A small build-up of a substance (likely protein) was observed inside the valve.Based on the investigation, the claim of valve not able to be adjusted was able to be substantiated.It is possible that the deposits observed inside the valve may have led to the malfunction.As described in scientific literature, the problem encountered is one of the known, inevitable risks of hydrocephalus (hc)-therapy by shunt implants.Based on the investigation, the claim of mechanical malfunction was not able to be substantiated.Manufacturing defects at the time of release have been excluded.The valve met all specifications of the final inspection when released from christoph miethke (b)(4).No further regulatory actions are required.
Event or Problem Description
It was reported to miethke that a progav valve (part # fv410t) was implanted during a procedure performed on an unknown date.According to the complainant, a failure of the adjustment mechanism occurred; the valve was not able to be adjusted.The physician underwent a revision procedure on an unknown date.The complaint device was returned to the manufacturer for evaluation.No patient complications were reported as a result of the revision procedure.Height: 175 centimeters (cm).

• Brand Name: PROGAV VALVE
• Common Device Name: HYDROCEPHALUS MANAGEMENT
• Manufacturer (Section D): CHRISTOPH MIETHKE GMBH & CO KG; ulanenweg 2; potsdam, 14469 ; GM 14469
• MDR Report Key: 12677269
• Report Number: 3004721439-2021-00701
• Device Sequence Number: 4530316
• Product Code: JXG
• UDI-Device Identifier: 04041906132071
• UDI-Public: 4041906132071
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• PMA/510(K) Number: K103003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/21/2021

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: 06/30/2019
• Device Model Number: FV410T
• Device Catalogue Number: FV410T
• Device Lot Number: 200254291
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/09/2017
• Initial Report FDA Received Date: 10/21/2021
• 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: 75 YR
• Patient Weight: 75