MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG PROGAV W/SHUNTASSIST.20 + DIST.CATH.; HYDROCEPHALUS MANAGEMENT

Model Number	FV420T
Medical Device Problem Codes	Mechanical Problem (1384); Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	06/12/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to miethke that a progav w/shuntassist.20 + dist.Cath.(part # fv420t) was implanted during a procedure performed on an unknown date.According to the complainant, the valve was suspected of being occluded and 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) kilograms (kg), height: 104 centimeters (cm), gender: unknown.
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 november 2014.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 cmh20.The valve was inspected as article fv420t.All parameters of the valve have been inspected and approved during the manufacturing process.All parameters have been assessed as meeting specification.Device examination: the progav® valve was returned submersed in an unidentified liquid in the provided returnkit.Visual inspection: although no significant deformation or damage of the valve were detected during the visual inspection, a deformation was indicated through a measurement of the plane parallelism.Permeability test: a permeability test has shown that the valve had a blockage.Adjustment test: the valve was tested and was not able to be adjusted throughout the normal range.Braking force and brake function test: the brake functionality test has shown that the brake function was operational, however, the braking force was not able to be measure due to the non-adjustability of the valve.Computer controlled test: a computer controlled test was not able to be performed because the valve was not permeable.Result: first, a visual inspection of the valve was performed.Although no significant deformation or damage of the valve were detected during the visual inspection, a deformation was indicated through a measurement of the plane parallelism.Next, the permeability, adjustability, as well as the brake functionally and brake force, of the valve were tested.The valve was neither permeable or adjustable.Furthermore, while the brake functionality was present, the braking force was unable to be measured due to the inability of the valve to hold a set pressure.Finally, the valve was dismantled.A build-up of a substance (likely protein) was observed inside the valve.Based on the investigation, the claim of the valve non-adjustability and occlusion were able to be substantiated.It is possible that the deposits observed inside the valve may have led to the reported malfunction.As described in scientific literature, the problem encountered is one of the known, inevitable risks of hydrocephalus (hc)-therapy by shunt implants.The cause of the deformation of the progav valve and the resultant defect of the rotor could not be determined.Manufacturing defects at the time of release have been excluded.The valve met all specifications of the final inspection when released from christoph miethke gmbh & co.Kg.No further regulatory actions are required.

• Brand Name: PROGAV W/SHUNTASSIST.20 + DIST.CATH.
• Common Device Name: HYDROCEPHALUS MANAGEMENT
• Manufacturer (Section D): CHRISTOPH MIETHKE GMBH & CO KG; ulanenweg 2; potsdam, 14469 ; GM 14469
• Manufacturer (Section G): CHRISTOPH MIETHKE GMBH & CO KG; ulanenweg 2; potsdam, 14469 ; GM 14469
• Manufacturer Contact: joerg knebel ; ulanenweg 2; potsdam, 14469 ; GM 14469
• MDR Report Key: 12832700
• Report Number: 3004721439-2021-00750
• Device Sequence Number: 19924627
• Product Code: JXG
• UDI-Device Identifier: 04041906132170
• UDI-Public: 4041906132170
• 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: 2017
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/17/2021

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: FV420T
• Device Catalogue Number: FV420T
• Device Lot Number: 20029340
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2017
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/22/2017
• Initial Report FDA Received Date: 11/17/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/26/2014
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 42 MO
• Patient Sex: Unknown
• Patient Weight: 22 KG