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

Model Number	FX648T
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	09/09/2021
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 january 2021.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® fixed pressure valve with a fixed pressure range of 20 cmh2o.The shunt system was inspected as article fx648t.All parameters have been inspected and approved during the manufacturing process.All parameters have been assessed as meeting specifications.Visual inspection no significant deformations or damage of the valves were detected during the visual inspection.Permeability test a permeability test has shown that both valves are permeable.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 is fully operational and the braking force is within the given tolerances.Internal inspection after dismantling of the valves, clearly deposits were found in progav® 2.0 but not in shuntassistant® results based on our investigation, we are unable to substantiate the clinical claim of occlusion.At the time of our investigation, the valves were shown to be permeable.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 shunt system 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.
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 have a blockage (high protein content).The patient underwent a revision procedure.The complainant device was returned to the manufacturer for evaluation.No patient complications were reported as a result of the revision procedure.Age: (b)(6) height: 60 cm weight: 8 kg gender: male.
Additional Manufacturer Narrative
Manufacturing and quality control data the progav® 2.0 shunt system was manufactured by a qualified employee in january 2021.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® fixed pressure valve with a fixed pressure range of 20 cmh2o.The shunt system was inspected as article fx648t.All parameters have been inspected and approved during the manufacturing process.All parameters have been assessed as meeting specifications.Visual inspection no significant deformations or damage of the valves were detected during the visual inspection.Permeability test a permeability test has shown that both valves are permeable.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 is fully operational and the braking force is within the given tolerances.Internal inspection after dismantling of the valves, clearly deposits were found in progav® 2.0 but not in shuntassistant® results based on our investigation, we are unable to substantiate the clinical claim of occlusion.At the time of our investigation, the valves were shown to be permeable.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 shunt system met all specifications of the final inspection when released from christoph miethke (b)(4) 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 have a blockage (high protein content).The patient underwent a revision procedure.The complainant device was returned to the manufacturer for evaluation.No patient complications were reported as a result of the revision procedure.Age: (b)(6), height: 60 cm, weight: (b)(6), gender: male.

• Brand Name: PROGAV 2.0 SHUNTSYSTEM
• 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: 12969367
• Report Number: 3004721439-2021-00323
• Device Sequence Number: 11866212
• Product Code: JXG
• UDI-Device Identifier: 04041906502065
• UDI-Public: 4041906502065
• 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 Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/09/2021

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: 01/17/2026
• Device Model Number: FX648T
• Device Catalogue Number: FX648T
• Device Lot Number: 20051317
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/16/2021
• Initial Report FDA Received Date: 12/09/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/19/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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 Age: 1 YR
• Patient Sex: Male
• Patient Weight: 8 KG