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

Model Number	FV424T
Medical Device Problem Codes	Mechanical Problem (1384); Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	04/13/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturer 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 miethke that a progav shuntsystem (part # fv424t) and a prosa valve (part # fv701t) (ref.Mdr id 3004721439-2021-00121) were implanted during a procedure performed in 2010.According to the complainant, the shuntsystem was believed to be operating in under-drainage and an adjustment problem occurred.The patient underwent a revision procedure on (b)(6) 2021.The complaint device was returned to the manufacturer for evaluation.No patient complications were reported as a result of the revision procedure.Age: (b)(6) years.Weight: (b)(6) kilograms (kg).Height: 155 centimeters (cm).Gender: male.The same event: medwatch # 3004721439-2021-00121.
Additional Manufacturer Narrative
The same event: medwatch #3004721439-2021-00121.Investigation: visual inspection: no significant deformations or damage of the valve were detected during the visual inspection.The progav valve housing was subsequently measured and showed no deviation.The housing measured at -0.02 mm, within the tolerance of 0 ± 0.02 mm.Permeability test: a permeability test has shown that the valve is permeable.Adjustment test: the progav 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.Computer controlled test: to investigate the claim of under-drainage, the opening pressure is measured using a miethke computer controlled testing apparatus which simulates a cerebrospinal fluid flow.The results show that the valve operates within the accepted tolerance in the horizontal position.Result: first, we performed a visual inspection of the progav.No significant deformations or damage of the valve were detected during the visual inspection.Next, we tested the permeability, adjustability, and opening pressure of the valve, as well as the brake functionality and brake force.The valve operates as expected and met all specifications.Finally, we have dismantled the valve.Inside the valve we have found a build-up of substances (likely protein).Based on our investigation, we are unable to substantiate the clinical claim of under-drainage and problem with the adjustability.At the time of our investigation, the opening pressure of the valve was within the specified tolerances and the valve was adjustable to all pressure settings.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 valve 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 SYSTEM WITH SPRUNG RESERVOIR
• Common Device Name: HYDROCEPHALUS MANAGEMENT
• Manufacturer (Section D): CHRISTOPH MIETHKE GMBH & CO KG; ulanenweg 2; potsdam, 14469 ; GM 14469
• MDR Report Key: 11816046
• Report Number: 3004721439-2021-00120
• Device Sequence Number: 3910899
• Product Code: JXG
• UDI-Device Identifier: 04041906132217
• UDI-Public: 4041906132217
• 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: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/29/2021

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 Model Number: FV424T
• Device Catalogue Number: FV424T
• Device Lot Number: 20010491
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/16/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/16/2021
• Supplement Date Received by Manufacturer: 06/08/2021
• Initial Report FDA Received Date: 05/13/2021
• Supplement Report FDA Received Date: 06/29/2021
• 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: 13 YR
• Patient Weight: 50