MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG PROGAV 2.0 SYS SA2.0 25 U.PAED.BOHRL.RES; HYDROCEPHALUS MANAGEMENT

Model Number	FX571T
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	03/21/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information/ investigation result will be submitted in a supplemental report.
Event or Problem Description
According to the complainant, the valve was believed to be operated underdrainage.The patient underwent a revision procedure.The complainant device was returned to the manufacturer for evaluation.No patient complications were reported as a result of the revision procedure.Implantation: (b)(6) 2021.Explantation: (b)(6) 2021.Age: (b)(6) month.Weight: (b)(6) 8 kg.Gender: male.
Additional Manufacturer Narrative
Investigation: visual inspection: dry deposits in the inlet spout of the shuntassistant 2.0, but no significant deformations or damage of the valves were detected during the visual inspection.Permeability test: a permeability test has indicated that the progav 2.0 has a blockage and the shuntassistant 2.0 is permeable.Computer controlled test: to investigate the claim of under-drainage, the opening pressure is measured using a miethke computer controlled testing apparatus which simulates a cerebrospinal fluid flow.The valve is tested in the vertical positions.The results show that the shuntassistant 2.0 operates not within the accepted tolerances.The valve showed a decreased outflow.Because the progav 2.0 valve is not permeable, a computer controlled test is not possible.Adjustment test: the progav 2.0 was tested and is not adjustable.Braking force and brake function test: the brake functionality test has shown that the brake function is operational, however the braking force cannot be measured due to the non-adjustability of the valve.Results: it should be noted that the product was received dry (i.E.Not submersed in liquid as recommended).The investigation of dry items is not significant due to the affect dry deposits of liquor and blood can have on product performance.In spite of this, we have investigated the valve to the best of our abilities.First, we performed a visual inspection of the progav 2.0 shunt system.Dry deposits with in the inlet spout of the shuntassistant 2.0, but no significant deformations or damage of the valves were detected during the visual inspection.Next, we tested the permeability, adjustability, and opening pressure of the valve, as well as the brake functionality and brake force.The progav 2.0 valve was neither permeable nor adjustable.Furthermore, while the brake functionality was present, the braking force was unable to be measured due to the non-adjustability of the valve.The opening pressure of the shuntassistant 2.0 was not within the tolerances.Finally, we have dismantled the valves.Inside both valves we have found build-up of substances (likely protein).It should be noted that the product was received dry (i.E.Not submersed in liquid as recommended).The investigation of dry items is not significant due to the affect dry deposits of liquor and blood can have on product performance.In spite of this, we have investigated the valve to the best of our abilities.We would like to point out in advance that an adjustment and permeability test has already been carried out after the revision.Based on our test results, at the time of our investigation, we can detect a blockage on the progav 2.0 and a slower flow on the shuntassistant 2.0.This is likely due to the deposits observed inside the valves.As described in scientific literature, the problem encountered is one of the known, inevitable risks of hc-therapy by shunt implants.We can exclude a defect at the time of release.The shunt system met all specifications of the final inspection when released from christoph miethke gmbh & co.Kg.No further regulatory actions are required from our point of view.

• Brand Name: PROGAV 2.0 SYS SA2.0 25 U.PAED.BOHRL.RES
• Common Device Name: HYDROCEPHALUS MANAGEMENT
• Manufacturer (Section D): CHRISTOPH MIETHKE GMBH & CO KG; ulanenweg 2; potsdam, 14469 ; GM 14469
• MDR Report Key: 11844943
• Report Number: 3004721439-2021-00129
• Device Sequence Number: 17268998
• Product Code: JXG
• UDI-Device Identifier: 04041906503987
• UDI-Public: 4041906503987
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K190174
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/07/2021

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: 08/05/2024
• Device Model Number: FX571T
• Device Catalogue Number: FX571T
• Device Lot Number: 20043721
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/21/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/21/2021
• Supplement Date Received by Manufacturer: 06/24/2021
• Initial Report FDA Received Date: 05/18/2021
• Supplement Report FDA Received Date: 07/07/2021
• 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: 2 YR
• Patient Weight: 8