MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG PROGAV 2.0 SYS SA2.0 20 & SPRUNG RESERV.; HYDROCEPHALUS MANAGEMENT

Model Number	FX576T
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	07/10/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation: visual inspection: unnormal and dark discoloration of the outer housing of the valves were observed through the visual inspection.No significant deformations or damage were detected.Permeability test: a permeability test has indicated that both valves have blockages.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 operates as expected.However, the breaking force required was not within the specified tolerances.Results: first, we performed a visual inspection of the progav 2.0 shunt system.The valves showed an unnormal and dark discoloration was detected.Next, we tested the permeability, adjustability, as well as the brake functionality and brake force.The valve was not permeable, and the braking force was not within the tolerance, but met all other specifications.Finally, we have dismantled the valves.Inside both valves we have found bloody build-up of substances (likely protein).Based on our investigation, we confirm the presence of occlusion in the system at the time of investigation.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.
Event or Problem Description
It was reported that a progav 2.0 shuntsystem (#fx576t) was implanted during a procedure performed on (b)(6) 2021.According to the complainant, the shunt system was believed to be operated in under-drainage.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), height: 60 cm, weight: (b)(6) gender: male.

• Brand Name: PROGAV 2.0 SYS SA2.0 20 & SPRUNG RESERV.
• Common Device Name: HYDROCEPHALUS MANAGEMENT
• Manufacturer (Section D): CHRISTOPH MIETHKE GMBH & CO KG; ulanenweg 2; potsdam, 14469 ; GM 14469
• MDR Report Key: 12290151
• Report Number: 3004721439-2021-00215
• Device Sequence Number: 11714065
• Product Code: JXG
• UDI-Device Identifier: 04041906502522
• UDI-Public: 4041906502522
• 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): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/06/2021

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: 07/02/2025
• Device Model Number: FX576T
• Device Catalogue Number: FX576T
• Device Lot Number: 20050040
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/16/2021
• Initial Report FDA Received Date: 08/06/2021
• 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: 33 MO
• Patient Weight: 10