MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG PROGAV SYS W.SA 25 A.CONTROL RESERVOIR; HYDROCEPHALUS MANAGEMENT

Model Number	FV435T
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	11/10/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information/ investigation results will be provided in a supplement report.The release for investigation is still pending.
Event or Problem Description
It was reported that there was a problem with a progav 2.0 shuntsystem.The surgeon reported that 2 years post operative the progav 2.0 was no longer adjustable.Additional details od the event is not available.Patient information: age y: (b)(6).Height cm: 183.Weight kg: (b)(6).Implantation: 2018.Explantation: (b)(6) 2020.
Additional Manufacturer Narrative
Investigation: visual inspection: no significant deformations or damage of the valves, but particle in the delivery liquid were detected during the visual inspection.The measurement of the outer housing showed no deviation of the planeparalism.Permeability test: a permeability test has shown that both valves are permeable.Adjustment test: the progav valve 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 shunt system.No significant deformations or damage of the valves were detected during the visual inspection.Next, we tested the permeability.Both valves were shown to be permeable.Additionally, we tested the adjustability as well as the brake functionality and brake force of the progav valve.The valve operated as expected and met all specifications.Finally, we have dismantled the valves.There were no visible deposits observed inside the progav valve.In the dismantled shuntassistant are minimal visible deposits.Based on our investigation, we are unable to substantiate the claim of non-adjustability.At the time of our investigation, the progav was able to be adjusted to all specified settings.During our investigation we could not find no deviations.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
New information: the release of investigation reached us on 11/06/2020.The investigation could be performed.

• Brand Name: PROGAV SYS W.SA 25 A.CONTROL RESERVOIR
• Common Device Name: HYDROCEPHALUS MANAGEMENT
• Manufacturer (Section D): CHRISTOPH MIETHKE GMBH & CO KG; ulanenweg 2; potsdam, 14469 ; GM 14469
• MDR Report Key: 10795289
• Report Number: 3004721439-2020-00221
• Device Sequence Number: 11475357
• Product Code: JXG
• UDI-Device Identifier: 04041906132477
• UDI-Public: 4041906132477
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K103003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/04/2020

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: 05/29/2023
• Device Model Number: FV435T
• Device Catalogue Number: FV435T
• Device Lot Number: 20038054
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/12/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/12/2020
• Supplement Date Received by Manufacturer: 11/10/2020
• Initial Report FDA Received Date: 11/05/2020
• Supplement Report FDA Received Date: 12/07/2020
• 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: 73 YR
• Patient Weight: 90