MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG PROGAV 2.0 SYS W.SA25 A.CONTROL RESERV.; HYDROCEPHALUS MANAGEMENT

Model Number	FX435T
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	03/30/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information/ investigation result will be submitted in a supplemental report.
Event or Problem Description
It was reported that a progav 2.0 shuntsystem (#fx435t) was implanted during a procedure performed on (b)(6) 2019.According to the complainant, the shuntsystem was believed to be operated in under-drainage.The ventricle of the patient were dilated.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.Age: (b)(6), weight: (b)(6), height: 173 cm, gender: female.
Additional Manufacturer Narrative
Investigation: visual inspection: some dry and bloody deposits on the products and a small hole in the distal peritoneal catheter were detected through the visual inspection.Permeability test: a permeability test has shown that the valve is permeable.Bloody liquid drained out during this test.Adjustment test: the progav 2.0 was tested and is adjustable to all specified pressures.Braking force and brake function test: the brake functionality test has shown that the brake function is fully operational and the braking force is within the given tolerances.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 results show that the valve operates within the accepted tolerance in the horizontal position.Result: it should be noted that the valve 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.Some dry and bloody deposits on the products and a small hole in the distal peritoneal catheter 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 valve operates as expected and met all specifications.Finally, we have dismantled the valve.Inside the valve we have found a build-up of substances (likely protein).Based on our investigation, we are unable to substantiate the clinical claim of underdrainage.At the time of our investigation, the opening pressure of the valve was within the specified tolerances.However, it is possible that the deposits observed inside the valve could have caused the malfunction in the past.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 valve 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 W.SA25 A.CONTROL RESERV.
• Common Device Name: HYDROCEPHALUS MANAGEMENT
• Manufacturer (Section D): CHRISTOPH MIETHKE GMBH & CO KG; ulanenweg 2; potsdam, 14469 ; GM 14469
• MDR Report Key: 11752869
• Report Number: 3004721439-2021-00102
• Device Sequence Number: 19875824
• Product Code: JXG
• UDI-Device Identifier: 04041906137335
• UDI-Public: 4041906137335
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K161853
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/23/2021

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: 12/13/2023
• Device Model Number: FX435T
• Device Catalogue Number: FX435T
• Device Lot Number: 20040205
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/06/2021
• Supplement Date Received by Manufacturer: 06/04/2021
• Initial Report FDA Received Date: 04/30/2021
• Supplement Report FDA Received Date: 06/23/2021
• 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: 25 YR
• Patient Weight: 80