MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG PROGAV 2.0 WITH CONTROL RESERVOIR; HYDROCEPHALUS MANAGEMENT

Model Number	FX467T
Medical Device Problem Code	Undercorrection (4058)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/24/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturing site evaluation: investigation on-going.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted.
Event or Problem Description
It was reported to aesculap inc.That a progav 2.0 with control reservoir (item # fx467t) was implanted on (b)(6) 2020.According to the complainant, during a clinical visit on (b)(6) 2022, the patient's valve was no longer able to be adjusted.The patient underwent a revision procedure on (b)(6) 2022.The complaint device was returned to the manufacturer for evaluation.No patient complications were reported as a result of the revision procedure.The adverse event / malfunction is filed under aic reference (b)(4).
Event or Problem Description
Investigation complete.
Additional Manufacturer Narrative
Investigation: visual inspection: the following observations were made during the visual inspection: residues tissues on the outlet of valve.Deposits in the control reservoir.Bloody delivery liquid with particles.Permeability test: the test showed that the progav 2.0 with control reservoir is permeable.Computer control test: the computer control test showed the opening pressure of the progav 2.0, at a reference flow rate of 20 ml/h in a horizontal.Position of the valve, to be 9.95 cmh2o.This is within the specified tolerance of 11 cmh2o ± 3 cmh2o.Adjustability test: the progav 2.0 was found to be adjustable to all pressure settings.Braking force and brake function test: the braking force of the progav 2.0 was within the specified tolerance and the brake function operated as expected.Internal inspection of product: in order to verify whether the investigated valve was compromised by the known risks of hydrocephalus therapy, e.G.By a buildup of natural substances (protein, blood, or tissue particles) in the cerebrospinal fluid, the valve is finally opened with a special tool.After dismantling of the valve, deposits were found.Results: for the sake of thoroughness and transparency, we would like to point out that a permeability test was already carried out after the revision at the hospital.Based on our investigation results, we can determine deposits.The deposits had no effect to the technical properties at the time of the investigation.The cause of the aforementioned functional impairment could be the determined deposits in the valve.Proteins in the cerebrospinal fluid can influence the function temporarily and are known side effects in hydrocephalus therapy.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.

• Brand Name: PROGAV 2.0 WITH CONTROL RESERVOIR
• Common Device Name: HYDROCEPHALUS MANAGEMENT
• Manufacturer (Section D): CHRISTOPH MIETHKE GMBH & CO KG; ulanenweg 2; potsdam, 14469 ; GM 14469
• MDR Report Key: 15781990
• Report Number: 2916714-2022-00110
• Device Sequence Number: 6676027
• Product Code: JXG
• UDI-Device Identifier: 04041906137083
• UDI-Public: 4041906137083
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 11/22/2022
• Report Date (Section F): 11/11/2022

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: 12/01/2024
• Device Model Number: FX467T
• Device Catalogue Number: FX467T
• Device Lot Number: 20044977
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/03/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 10/24/2022
• Device Age: 35 MO
• Event Location: Hospital
• Date Report to Manufacturer: 10/24/2022
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/11/2022
• Supplement Report FDA Received Date: 11/22/2022
• 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: 69 YR
• Patient Sex: Female
• Patient Weight: 78 KG
• Date Report Sent to FDA: 11/11/2022