MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG PROGAV 2.0 SYS W/SA20 A.SPRUNG RESERVOIR; HYDROCEPHALUS MANAGEMENT

Model Number	FX427T
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	01/26/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This complaint was reopened in reference to (b)(4).Investigation: ( description incoming product condition) we received the valve in an unknown liquid.The progav was set to pressure range 10 cmh2o at the time of delivery.Summary: in the visual inspection of the valve, we could not detect any apparent damage.It was possible to adjust the valve up and down again in steps of 5 cmh2o.To prove if the brake function is full in place we carried out a brake function test.The investigation has shown that the brake function is present.Further we carried out a permeability test.The investigation has resulted that the valve is permeable.Given the fact that during the treatment with shunts the following complications may arise (as described in the literature): infections, blockages caused by protein and/or blood in the cerebrospinal fluid, over/under drainage or in very rare cases, noise development we decided to dismantle the valve.Inside the valve we could find apparent deposits or substances of protein which might could be the reason for the assumed blockage.Based on our test results the clogging can not be confirmed.Perhaps the deposits inside the valve could have influenced the function in the past.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 actions required.
Event or Problem Description
According to the complainant a progav could not be readjusted postoperatively.The patient was originally implanted on (b)(6) 2016.The initial pressure value was 8 cmh2o.The valve was explanted on (b)(6) 2017 and returned to the manufacturer for evaluation.During the revision surgery, the surgeon noted drainage from the valve, but not from the reservoir; blockage was suspected.Height: 170 cm.

• Brand Name: PROGAV 2.0 SYS W/SA20 A.SPRUNG RESERVOIR
• Common Device Name: HYDROCEPHALUS MANAGEMENT
• Manufacturer (Section D): CHRISTOPH MIETHKE GMBH & CO KG; ulanenweg 2; potsdam, 14469 ; GM 14469
• MDR Report Key: 12728960
• Report Number: 3004721439-2021-00705
• Device Sequence Number: 4499007
• Product Code: JXG
• UDI-Device Identifier: 04041906136970
• UDI-Public: 4041906136970
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: foreign,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/01/2021

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: FX427T
• Device Catalogue Number: FX427T
• Device Lot Number: 20031361
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/03/2017
• Initial Report FDA Received Date: 11/01/2021
• 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 Weight: 80