MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG PROGAV 2.0 WITH SA25 A.CONTROL RESERVOIR; HYDROCEPHALUS MANAGEMENT

Model Number	FX479T
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	07/13/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This complaint was reopened in reference to (b)(4).Manufacturing site evaluation: manufacturing and quality control data.The progav® 2.0 was manufactured by a qualified employee in (b)(6) 2015.Deviations during assembly did not occur.The valve was sterilized by miethke and released for shipment after final inspection.The progav® 2.0 has a normal pressure range of 0 to 20 cmh2o.The valve was inspected as article fx479t.All parameters have been inspected and approved during the manufacturing process.All parameters have been assessed as meeting specification.Device examination: the valve was received submersed in an unidentified liquid in the provided return kit.Visual inspection: scratches and a significant deformation of the outer housing of the valve were observed during the visual inspection.Permeability test: a permeability test has shown that the valve was permeable.Adjustment test: the progav® was tested and was adjustable to all specified pressures.Braking force and brake function test: the brake functionality test revealed that the brake function was fully operational and the braking force was within the given tolerances.Result first, we performed a visual inspection of the progav®.Scratches and a significant deformation of the outer housing of the valve were observed.Next, the permeability, adjustability, as well as the brake functionally and brake force, of the valve were tested.The valve operated as expected and met all specifications.Finally, the valve was dismantled.A build-up of a substance (likely protein) was observed inside the valve.Based on the investigation, the claim of non-adjustability was not able to be substantiated.The valve was able to be adjusted to all specified settings.However, it is possible that the deposits observed inside the valve could have led to the reported malfunction.As described in scientific literature, the problem encountered is one of the known, inevitable risks of hydrocephalus (hc)-therapy by shunt implants.Manufacturing defects at the time of release have been excluded.The valve met all specifications of the final inspection when released from christoph miethke (b)(4).No further regulatory actions are required.
Event or Problem Description
It was reported miethke that a progav 2.0 with sa25 a.Control reservoir (part # fx479t) was implanted during a procedure performed on an (b)(6) 2016.According to the complainant, the valve was not able to be adjusted.The patient underwent a revision procedure on (b)(6) 2017.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).Weight: (b)(6).Height: 93 centimeters (cm).Gender: unknown.
Event or Problem Description
It was reported miethke that a progav 2.0 with sa25 a.Control reservoir (part # fx479t) was implanted during a procedure performed on an (b)(6) 2016.According to the complainant, the valve was not able to be adjusted.The patient underwent a revision procedure on (b)(6) 2017.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).Weight: (b)(6).Height: 93 centimeters (cm).Gender: unknown.
Additional Manufacturer Narrative
This complaint was reopened in reference to (b)(4).Manufacturing site evaluation: manufacturing and quality control data.The progav® 2.0 was manufactured by a qualified employee in (b)(6) 2015.Deviations during assembly did not occur.The valve was sterilized by miethke and released for shipment after final inspection.The progav® 2.0 has a normal pressure range of 0 to 20 cmh2o.The valve was inspected as article fx479t.All parameters have been inspected and approved during the manufacturing process.All parameters have been assessed as meeting specification.Device examination: the valve was received submersed in an unidentified liquid in the provided return kit.Visual inspection: scratches and a significant deformation of the outer housing of the valve were observed during the visual inspection.Permeability test: a permeability test has shown that the valve was permeable.Adjustment test: the progav® was tested and was adjustable to all specified pressures.Braking force and brake function test: the brake functionality test revealed that the brake function was fully operational and the braking force was within the given tolerances.Result first, we performed a visual inspection of the progav®.Scratches and a significant deformation of the outer housing of the valve were observed.Next, the permeability, adjustability, as well as the brake functionally and brake force, of the valve were tested.The valve operated as expected and met all specifications.Finally, the valve was dismantled.A build-up of a substance (likely protein) was observed inside the valve.Based on the investigation, the claim of non-adjustability was not able to be substantiated.The valve was able to be adjusted to all specified settings.However, it is possible that the deposits observed inside the valve could have led to the reported malfunction.As described in scientific literature, the problem encountered is one of the known, inevitable risks of hydrocephalus (hc)-therapy by shunt implants.Manufacturing defects at the time of release have been excluded.The valve met all specifications of the final inspection when released from christoph miethke (b)(4).No further regulatory actions are required.

• Brand Name: PROGAV 2.0 WITH SA25 A.CONTROL 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: 12964392
• Report Number: 3004721439-2021-00782
• Device Sequence Number: 19966850
• Product Code: JXG
• UDI-Device Identifier: 04041906137120
• UDI-Public: 4041906137120
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K141687
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2017
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/08/2021

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: 06/30/2020
• Device Model Number: FX479T
• Device Catalogue Number: FX479T
• Device Lot Number: 20028103
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/20/2017
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/27/2017
• Initial Report FDA Received Date: 12/08/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/08/2015
• 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: 30 MO
• Patient Sex: Unknown
• Patient Weight: 11 KG