MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG PROGAV 2.0 SYS W/SA20 A.CONTROL RESERV.; HYDROCEPHALUS MANAGEMENT

Model Number	FX434T
Medical Device Problem Codes	Mechanical Problem (1384); Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	05/11/2021
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 that a progav 2.0 shuntsystem (part # fx434t) was implanted during a procedure performed sometime in 2019.According to the complainant, the valve was believed to have a blockage and the device was not able to be adjusted.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) height: 103 centimeters (cm) weight: (b)(6) gender: female.
Additional Manufacturer Narrative
Investigation: visual inspection: no significant deformations or damage of the valves were detected during the visual inspection.Particles were found in the liquid the shunts system was delivered in.Permeability test: a permeability test has shown that both valves are permeable.Adjustment test: the progav 2.0 was tested and was no longer adjustable.The shuntassistant is a fixed pressure valve, therefore the adjustability test is inapplicable.Braking force and brake function test: the brake functionality test has shown that he brake function is operational, however the braking force cannot be measured due to the non-adjustability of the valve.Results: first, we performed a visual inspection of the progav 2.0 shunt system.No significant deformations or damage of the valves were detected during the visual inspection.Next, we tested the permeability, adjustability, as well as the brake functionality and brake force.The progav 2.0 was permeable but was no longer adjustable.The shuntassistant operates as expected and met all specifications.Finally, we have dismantled the valves.Inside both valves we have found build-up of substances (likely protein).Based on our investigation, we confirm that the progav 2.0 was non-adjustable at the time of our investigation.We are assuming that the deposits detected within the valve have caused the functional impairment.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.We can exclude a defect at the time of release.The shunt system met all specificationsof 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 2.0 SYS W/SA20 A.CONTROL RESERV.
• Common Device Name: HYDROCEPHALUS MANAGEMENT
• Manufacturer (Section D): CHRISTOPH MIETHKE GMBH & CO KG; ulanenweg 2; potsdam, 14469 ; GM 14469
• MDR Report Key: 12004009
• Report Number: 3004721439-2021-00157
• Device Sequence Number: 19107377
• Product Code: JXG
• UDI-Device Identifier: 04041906137328
• UDI-Public: 4041906137328
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K161853
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/04/2021

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 Expiration Date: 03/10/2024
• Device Model Number: FX434T
• Device Catalogue Number: FX434T
• Device Lot Number: 20041151
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/17/2021
• Supplement Date Received by Manufacturer: 07/14/2021
• Initial Report FDA Received Date: 06/15/2021
• Supplement Report FDA Received Date: 08/04/2021
• 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: 4 YR
• Patient Weight: 16