MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG PROGAV WITH SHUNTASSISTANT 10; HYDROCEPHALUS MANAGEMENT

Model Number	FV411T
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	04/11/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to aesculap inc.That a progav 2.0 (#fx490t) was implanted during a procedure performed in 2010.According to the complainant according to the complainant, the shunt system has never been adjusted since it´s initial implant.When it was to be adjusted, it was not possible to change the valves settings.A revision has been scheduled for (b)(6) 2024.The complainant device will be returned to the manufacturer for evaluation.At the time of the creation of this submission, no patient complications were reported as a result of the revision procedure.The adverse event is filed under aic reference (b)(4).
Additional Manufacturer Narrative
Investigation on-going.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted.
Additional Manufacturer Narrative
Corrected information: a2 patient age brand name d4 additional device information d9 device returned to manufacturer yes, date returned to manfucturer.Additional information: a3a patient sex a4 patient weight b7 relevant history d4 additional device information f9 apprixmate age of the device.Investigation: visual inspection: during the investigation, no significant deformation or damage of the shuntsystem were determined.Permeability test: a permeability test has shown that all components are permeable.Computer controlled test: the opening pressure is measured by using a miethke computer controlled testing apparatus which simulates a cerebrospinal fluid flow.The valves were tested in both the horizontal as well as the vertical positions.The results show that the valves operate within the permissible tolerance in their respective relevant positions.Adjustment test: the progav was tested and is not adjustable.Braking force and brake function test: the brake functionality test has shown that the brake function operates as expected.However, the breaking force cannot be measured due to the non-adjustability of the valve.Internal inspection : after dismantling of the valves, deposits were found in both valves.

• Brand Name: PROGAV WITH SHUNTASSISTANT 10
• Common Device Name: HYDROCEPHALUS MANAGEMENT
• Manufacturer (Section D): CHRISTOPH MIETHKE GMBH & CO KG; ulanenweg 2; potsdam, 14469 ; GM 14469
• MDR Report Key: 19118526
• Report Number: 2916714-2024-00074
• Device Sequence Number: 15231897
• Product Code: JXG
• UDI-Device Identifier: 04041906132088
• UDI-Public: 4041906132088
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/10/2024
• Report Date (Section F): 04/16/2024

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: 02/08/2016
• Device Model Number: FV411T
• Device Catalogue Number: FV411T
• Device Lot Number: 20012987
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 03/27/2024
• Device Age: 13 YR
• Event Location: Hospital
• Date Report to Manufacturer: 03/27/2024
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/16/2024
• Supplement Report FDA Received Date: 05/10/2024
• 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: 31 YR
• Patient Sex: Female
• Patient Weight: 68 KG
• Date Report Sent to FDA: 04/16/2024