MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG PROGAV 2.0 SYS SA2.0 20 U.PAED.BOHRL.RES; HYDROCEPHALUS MANAGEMENT

Model Number	FX570T
Medical Device Problem Codes	Mechanical Problem (1384); Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	08/11/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturing and quality control data: the progav® 2.0 shunt system was manufactured by a qualified employee in december 2020.Deviations during assembly did not occur.The system was sterilized by miethke and released for shipment after final inspection.For the purposes of this investigation, the progav® 2.0 shunt system is comprised of a progav® 2.0 adjustable pressure valve with a normal pressure range of 0 to 20 cmh2o and a shuntassistant® 2.0 fixed pressure valve with a fixed pressure range of 20 cmh2o.The shunt system was inspected as article fx570t.All parameters have been inspected and approved during the manufacturing process.All parameters have been assessed as meeting specifications.Permeability test: a permeability test has indicated that the shuntassistant® 2.0 has a blockage and the progav® 2.0 valve is permeable.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 valve are tested in the horizontal positions.The result shown that the progav® 2.0 valve was not operated within the acceptable tolerance in horizontal position.Adjustment test: the progav® 2.0 was tested and is adjustable to all specified pressures.Klick force and brake function test: the brake functionality test has shown that the brake function operates as expected.However, the breaking force required was not within the specified tolerances.Internal inspection : after dismantling of the valves, clearly deposits were found in both valves.Results: based on our investigation, we confirm that the shuntsystem shows an increased flow of liquid an blockage at the time of our investigation.This is likely due to the deposits observed inside the valves.As described in scientific literature, the problem encountered is one of the known, inevitable risks of hc-therapy by shunt implants.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.Small amounts of non-visible deposits/proteins might compromise the integrity of the valve.No further regulatory actions are required from our point of view.
Event or Problem Description
It was reported that a progav 2.0 shuntsystem was implanted during a procedure performed on (b)(6) 2021.According to the complainant, the shunt system was believed to be operating in underdrainage and was difficult to adjust.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: 68 centimeters (cm).Weight: (b)(6).Gender: male.

• Brand Name: PROGAV 2.0 SYS SA2.0 20 U.PAED.BOHRL.RES
• Common Device Name: HYDROCEPHALUS MANAGEMENT
• Manufacturer (Section D): CHRISTOPH MIETHKE GMBH & CO KG; ulanenweg 2; potsdam, 14469 ; GM 14469
• MDR Report Key: 12375025
• Report Number: 3004721439-2021-00241
• Device Sequence Number: 17124627
• Product Code: JXG
• UDI-Device Identifier: 04041906503970
• UDI-Public: 4041906503970
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K190174
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/26/2021

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: 11/03/2025
• Device Model Number: FX570T
• Device Catalogue Number: FX570T
• Device Lot Number: 20050814
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/13/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/13/2021
• Initial Report FDA Received Date: 08/26/2021
• 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: 7 MO
• Patient Weight: 6