MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG PROGAV 2.0 WITH SA20 AND DISTAL CATHETER; HYDROCEPHALUS MANAGEMENT

Model Number	FX420T
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	04/06/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to miethke that a progav 2.0 with sa20 and distal catheter (part # fx420t) was implanted during a procedure performed on (b)(6) 2017.According to the complainant, the fv046 and fx420t were implanted during the primary surgery with an initial value of 5cmh20.The day after the primary surgery, over-drainage was observed.The pressure value was re-adjusted up to 18cmh20 to cope with over-drainage, and the patient's condition improved.However, ventricular enlargement was observed as a result of the elevated opening pressure, and the valve was re-adjusted down to 2 cmh20 on step by step basis.By decreasing the opening pressure, the patient exhibited over-drainage symptoms and by elevating the pressure, under-drainage symptoms occurred.Shunt radiograph revealed no obstruction of the shunt pathway.Therefore, the patient underwent a revision procedure on (b)(6) 2017 to remove only the gravitational valve.The complaint device was returned to the manufacturer for evaluation.No patient complications were reported as a result of the revision procedure.Age: unknown, weight: (b)(6), height: 180 centimeters (cm), gender: male.
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 feburary 2016.Deviations during assembly did not occur.The valve was sterilized by miethke and released for shipment after final inspection.The valve has a normal pressure rating of 20 cmh20.The valve was inspected as article fx420t.All parameters (opening pressure, reflux, tightness) have been inspected and approved during the manufacturing process.All parameters have been assessed as meeting specification.Device examination: the valve was received in an unknown liquid in the provided return kit.Visual inspection: no significant deformations or damage to the valve were detected during the visual inspection.Permeability test: a permeability test has shown that the valve was not penetrable.Adjustment test: an adjustment test was not applicabe as the valve has a fixed pressure.Braking force and brake function test: a braking force and brake function test were not applicable as the valve has a fixed pressure.Computer controlled test: the test is performed with miethke computer controlled testing apparatus.The valve was tested by simulating a liquor flow between 60 ml/h down to 5 ml/h and up again to 60 ml/h in vertical position (in acc.To iso 7197).Distilled water was used as test-liquid.The shuntassistant operated within the accepted tolerances.Result: a visual inspection of the valve was performed.No significant deformations or damage to the valve were detected during the visual inspection.Next, the valve permeability was tested, which revealed that the valve was not penetrable.A computer controlled test was performed which confirmed that the shuntassistant operated within the accepted tolerances.Finally, the valve was dismantled.A build-up of a substance (likely protein) was observed inside the valve.Based on the investigation, the valve was found to be occluded.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.

• Brand Name: PROGAV 2.0 WITH SA20 AND DISTAL CATHETER
• 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: 12957134
• Report Number: 3004721439-2021-00771
• Device Sequence Number: 17495267
• Product Code: JXG
• UDI-Device Identifier: 04041906136628
• UDI-Public: 4041906136628
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K141687
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/07/2021

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: 06/30/2021
• Device Model Number: FX420T
• Device Catalogue Number: FX420T
• Device Lot Number: 20031623
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/11/2017
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/29/2017
• Initial Report FDA Received Date: 12/07/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/16/2016
• 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 Sex: Male
• Patient Weight: 65 KG