MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG PROGAV 2.0 WITH SHUNTASSISTANT 10; HYDROCEPHALUS MANAGEMENT

Model Number	FX411T
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	04/12/2017
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 august 2015.Deviations during assembly did not occur.The valve was sterilized by miethke and released for shipment after final inspection.The progav® has a normal pressure range of 0 to 20 cmws.The valve specifications after closing the valve for 5 ml/h or 50 ml/h flow, for set pressure range 0, 10, 20 cmh2o were fine.The valve was inspected as article fx411t.All parameters (opening pressure, reflux, tightness, adjustability and brake function) have been inspected and signed during the manufacturing process.All parameters have been assessed as okay.Before release the progav 2.0 was pre-adjusted to pressure setting 5 cmh2o.Device examination: the progav 2.0® was returned submersed in an unidentified liquid in the provided returnkit.At the time of submission the progav 2.0 valve was set to pressure range 10 cmh2o.Visual inspection: slight scratches on the outer housing of the valve were observed through the visual inspection.No significant deformations or damage were detected.Permeability test: a permeability test has shown that the valve was permeable.Adjustment test: the progav 2.0® was tested and was adjustable to all specified pressures.Braking force and brake function test: the brake functionality test has shown that the brake function was fully operational and the braking force was within the given tolerances.Result: first, a visual inspection of the progav 2.0® was performed.No significant deformations or damage to the valve were detected during the visual inspection apart from slight scratches.Next, the permeability, adjustability, as well as the brake functionally and brake force, of the valve were tested.The valve operates 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 occlusion was not able to be substantiated.At the time of the investigation, no detectable failure was observed with this valve.However, it is possible that the deposits observed inside the valve could have led to the reported event.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.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 shuntassistant 10 (part # fx411t) was implanted during a procedure performed on an unknown date.According to the complainant, the patient returned for surgery approximately twelve (12) months after the valve was implanted.The physician suspected a distal or proximal occlusion.Reportedly, a manometer was used on each side of the valve, the valve was then checked with a checkmate to confirm its setting was at ten (10).Once the setting was confirmed, the physician injected saline, which revealed that the progav allowed complete flow through without the setting having any affect on flow.At this time, the decision was made to replace the valve.The existing reservoir was left in place and a new valve (part # fx412t) was implanted at a setting of ten (10).The physician then able to successfully perform a flow retest.The complaint device was returned to the manufacturer for evaluation.No patient complications were reported as a result of the revision procedure.

• Brand Name: PROGAV 2.0 WITH SHUNTASSISTANT 10
• 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: 12787580
• Report Number: 3004721439-2021-00731
• Device Sequence Number: 5094897
• Product Code: JXG
• UDI-Device Identifier: 04041906136536
• UDI-Public: 4041906136536
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K141687
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2017
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/10/2021

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: FX411T
• Device Catalogue Number: FX411T
• Device Lot Number: 20027538
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/05/2017
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/12/2017
• Initial Report FDA Received Date: 11/10/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/21/2015
• 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 Sex: Unknown