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	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	12/07/2016
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 may 2016.Deviations during assembly did not occur.The valve was sterilized by miethke and released for shipment after final inspection.The progav® has a normal pressure range of 0 to 20 cmh2o.The shunt system was inspected as article fv427t.All parameters have been inspected and approved during the manufacturing process.All parameters have been assessed as meeting specifications.Device examination: the progav® valve was returned submersed in an unidentified liquid.Visual inspection: no significant deformations or damage were detected.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 were detected.Next, the permeability, adjustability, as well as the brake functionally and brake force, of the valve were tested.The valve operated as expected and met all specifications.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 claim of occlusion was not able to be substantiated.Based on the investigation, the valve was found to be occluded.However, it is possible that deposits observed inside the valve could have caused the malfunction.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 in (b)(6).According to the complainant, the valve was blocked.The patient underwent a revision procedure on (b)(6) 2016.The complaint device was returned to the manufacturer for evaluation.No patient complications were reported as a result of the revision procedure.

• 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: 12668829
• Report Number: 3004721439-2021-00689
• Device Sequence Number: 16438906
• Product Code: JXG
• UDI-Device Identifier: 04041906132248
• UDI-Public: 4041906132248
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K103003
• 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: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/20/2021

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: FV427T
• Device Catalogue Number: FV427T
• Device Lot Number: 20031035
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/13/2017
• Initial Report FDA Received Date: 10/20/2021
• 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: 10 MO