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

Model Number	FX442T
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	04/22/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturing site evaluation: additional information / investigation results will be provided in a supplemental report, if available.
Event or Problem Description
It was reported that a progav 2.0 shuntsystem (#fx442t) was implanted during a procedure performed on (b)(6) 2019.According to the complainant, the valve was believed to be not adjustable.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.Patient informations: age: (b)(6) height: 120 cm weight: (b)(6).
Additional Manufacturer Narrative
Investigation: visual inspection: no significant deformations or damage of the valves were detected during the visual inspection.Permeability test: a permeability test has shown that both valves are permeable.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.Results: first, we performed a visual inspection of the progav 2.0 shunt system.No significant deformations or damage of the valves were detected during the visual inspection.Next, we tested the permeability, adjustability, the brake functionality and brake force.The valve operates as expected and met all specifications.Finally, we have dismantled the valves.Inside the progav 2.0 we have found build-up of substances (likely protein) in the shuntassistant were no visible deposits detected.Based on our test results, we cannot detect a malfunction on the shunt system at the time of our investigation.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 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 PED.W/SA25 A.PRECHAMBER
• Common Device Name: HYDROCEPHALUS MANAGEMENT
• Manufacturer (Section D): CHRISTOPH MIETHKE GMBH & CO KG; ulanenweg 2; potsdam, 14469 ; GM 14469
• MDR Report Key: 11921908
• Report Number: 3004721439-2021-00152
• Device Sequence Number: 14248005
• Product Code: JXG
• UDI-Device Identifier: 04041906137472
• UDI-Public: 4041906137472
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/12/2021

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: 05/04/2022
• Device Model Number: FX442T
• Device Catalogue Number: FX442T
• Device Lot Number: 20033899
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/07/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/07/2021
• Supplement Date Received by Manufacturer: 07/02/2021
• Initial Report FDA Received Date: 06/02/2021
• Supplement Report FDA Received Date: 07/12/2021
• 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: 7 YR
• Patient Weight: 29