MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG PROGAV 2.0 SYSTEM W. SPRUNG RESERVOIR; HYDROCEPHALUS MANAGEMENT

Model Number	FX424T
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	01/23/2022
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 ag that a progav 2.0 shunt system (part # fx424t) was implanted on an unknown date.According to the complainant, the surgeon was unable to adjust the valve.Reportedly, the surgeon placed the valve in a very difficult (mastoid bone) location, therefore, it was difficult to locate and adjust the valve.The patient felt "bad" and the adjustment was worsening according to the x-ray.The patient underwent a revision procedure on (b)(6) 2022.The complaint device has not been returned to the manufacturer for evaluation.No patient complications were reported as a result of the revision procedure.
Additional Manufacturer Narrative
Investigation: visual inspection: the following observations were made during the visual inspection: - no abnormalities were observed permeability test: the test showed that the progav 2.0 is permeable.During the test, bloody liquid was flushed out.Computer control test: the computer controlled 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 22,68 cmh2o.This is not within the specified tolerance of 19 cmh2o ± 3 cmh2o.An applied pressure of 19 cmh2o, with the device in the horizontal position is expected to have a resultant pressure of 19 cmh2o ± 3 cmh2o.Additional testing confirms the first test results.According to our results, we can detect a presence of a slowed outflow.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 build-up of natural substances (protein, blood, or tissue particles) in the cerebrospinal fluid, we have dismantled the valve.After dismantling of the valve, no deposits were found in the progav 2.0.Traces of blood are visible on the cover of the valve.Results: we would like to note in advance that the returned product was not submerged in liquid at the time of receipt.The testing of valves sent in a dry condition is only of a limited value.The product performance can be affected by dry residues of cerebrospinal fluid or blood.Despite this we have tested the device to the best of our abilities.Based on our investigation results, we can identify a slowed outflow in the valve.Deposits caused by natural substances in the cerebrospinal fluid, such as protein, blood or tissue particles, are among the known and unavoidable risks and side effects of hydrocephalus therapy.Even small amounts of non-visible deposits/proteins might compromise the integrity of the valve.We can exclude a defect at the time of release.The valve met all specifications of the final inspection when released from (b)(6).From our point of view, no further regulatory actions are required.

• Brand Name: PROGAV 2.0 SYSTEM W. SPRUNG RESERVOIR
• Common Device Name: HYDROCEPHALUS MANAGEMENT
• Manufacturer (Section D): CHRISTOPH MIETHKE GMBH & CO KG; ulanenweg 2; potsdam, 14469 ; GM 14469
• Manufacturer (Section G): CHRISTOPH MIETHKE GMBH & CO KG; ulanenweg 2; potsdam, 14469 ; GM 14469
• Manufacturer Contact: joerg knebel ; ulanenweg 2; potsdam, 14469 ; GM 14469
• MDR Report Key: 13552808
• Report Number: 3004721439-2022-00030
• Device Sequence Number: 5199942
• Product Code: JXG
• UDI-Device Identifier: 04041906136949
• UDI-Public: 4041906136949
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K161853
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/30/2022

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 05/18/2026
• Device Model Number: FX424T
• Device Catalogue Number: FX424T
• Device Lot Number: 20053254
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/27/2022
• Supplement Date Received by Manufacturer: 03/02/2022
• Initial Report FDA Received Date: 02/17/2022
• Supplement Report FDA Received Date: 03/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/20/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown