MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG PROGAV SYSTEM W/SA 20 A.SPRUNG RESERVOIR; HYDROCEPHALUS MANAGEMENT

Model Number	FV427T
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	01/11/2017
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 progav® was manufactured by a qualified employee in january 2016.Deviations during assembly did not occur.The valve was sterilized by miethke and released for shipment after final inspection.The progav 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 set pressure range 0, 10, 20 cmh2o were fine.The valve was inspected as article fx434t.All parameters (opening pressure, reflux, tightness, adjustability and brake function) have been inspected and signed during the manufacturing process.All parameters have been assessed as okay.Before release the progav was pre-adjusted to pressure setting 5 cmh2o.Device examination: the progav® valve was returned in an unidentified liquid.At the time of submission the progav valve was set to pressure range 7 cmh2o.Visual inspection: the visual inspection revealed that the valve has no deformations or other abnormalities.However, the examination of the parallelism, identified a deviation from the tolerance.Permeability test: a permeability test has shown that the valve was permeable.Adjustment test: the progav® was tested and was adjustable to all specified pressures.Braking force and brake function test: the brake functionality test has shown that the brake function was fully operational and the braking force was within expected tolerances.Result: first, a visual inspection of the progav® was performed.No significant deformations or damage to the valve were detected during the visual inspection, however, a deformation was detected through a measurement of the plane parallelity.Next, the permeability, adjustability, as well as the brake functionally and brake force, of the valve were tested.The valve met all specifications.As a final examination, a computer controlled test was performed.The valve was found to not be working inside the accepted tolerance.Finally, the valve was dismantled.A small amount of build-up of a substance (likely protein) was observed inside the valve.Based on the investigation, the valve underdrainage was confirmed.This was 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 hydrocephalus (hc)-therapy by shunt implants.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 system w/sa 20 a.Sprung reservoir (part # fv427t) was implanted during a procedure performed on an unknown date.According to the complainant, the valve pressure was not able to be adjusted.The patient underwent a revision procedure on an (b)(6) 2017.The complaint device was returned to the manufacturer for evaluation.No patient complications were reported as a result of the revision procedure.Age - (b)(6).Weight - (b)(6).Height - 178.4 centimeters (cm).Gender - male.

• Brand Name: PROGAV SYSTEM W/SA 20 A.SPRUNG RESERVOIR
• Common Device Name: HYDROCEPHALUS MANAGEMENT
• Manufacturer (Section D): CHRISTOPH MIETHKE GMBH & CO KG; ulanenweg 2; potsdam, 14469 ; GM 14469
• MDR Report Key: 12658489
• Report Number: 3004721439-2021-00690
• Device Sequence Number: 4480849
• Product Code: JXG
• UDI-Device Identifier: 04041906132248
• UDI-Public: 4041906132248
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K103003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2017
• 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): 10/19/2021

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: FV427T
• Device Catalogue Number: FV427T
• Device Lot Number: 20022530
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/13/2017
• Initial Report FDA Received Date: 10/19/2021
• 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: 65 YR
• Patient Weight: 82