MAUDE Adverse Event Report: PROGAV SYS PED.W/SA 20 A.PRECHAMBER; HYDROCEPHALUS MANAGEMENT

Model Number	FV441T
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	03/15/2017
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® was manufactured by a qualified employee in may 2016.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 cmh2o.The shunt system was inspected as article fv441t.All parameters have been inspected and approved during the manufacturing process.All parameters have been assessed as meeting specifications.Device examination: the progav® was returned submersed in an unidentified liquid in the provided returnkit.Visual inspection: no significant deformations or damage were detected during the visual inspection.Permeability test: a permeability test has shown that the valve was permeable.Adjustment test: the progav® was tested and was initially difficult to adjust.In the second attempt, it was possible to adjust the valve 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.Computer controlled test: to investigate over/under-drainage, the opening pressure was measured using a miethke computer controlled testing apparatus which simulates a cerobrospinal fluid flow.The first measurement revealed that the valve in the horizontal body position was slightly outside the permissible tolerance.The valve tends to underdrainage.A second test showed improvement of the values.The measured values were within the permissible tolerance.Result: first, a visual inspection of the progav® was performed.No significant deformations or damage to the valve were detected during the visual inspection.Next, the permeability, adjustability, as well as the brake functionally and brake force, of the valve were tested.The progav was initially difficult to adjust.However, in the second attempt, it was possible to adjust the valve to all specified pressures.During the first measurement, the valve was slightly outside the permissible tolerance in the horizontal body position.However, a second test showed improvement of the values which were within the permissible tolerance.All other specifications were met.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 a blockage was able to be substantiated.This was likely due to the deposits observed inside the valve.As described in scientific literature, the problem encountered is one of the known, inevitable risks of hydrocephalus therapy (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 sys ped.W/sa 20 a.Prechamber (part # fv441t) was implanted during a procedure performed on (b)(6) 2016.According to the complainant, the valve was believed to have a blockage and to be operating in under-drainage.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: 55 centimeters (cm).Gender: unknown.

• Brand Name: PROGAV SYS PED.W/SA 20 A.PRECHAMBER
• Common Device Name: HYDROCEPHALUS MANAGEMENT
• MDR Report Key: 12746545
• Report Number: 3004721439-2021-00716
• Device Sequence Number: 11882334
• Product Code: JXG
• UDI-Device Identifier: 04041906132545
• UDI-Public: 4041906132545
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K103003
• 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: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/03/2021

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: 12/31/2020
• Device Model Number: FV441T
• Device Catalogue Number: FV441T
• Device Lot Number: 20030228
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/29/2017
• Initial Report FDA Received Date: 11/03/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/09/2016
• 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; Disability
• Patient Age: 12.5 MO
• Patient Weight: 8