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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO. KG GAV 2.0 SYS W/PED.CONTROL RESERV.10/30; HYDROCEPHALUS MANAGEMENT
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CHRISTOPH MIETHKE GMBH & CO. KG GAV 2.0 SYS W/PED.CONTROL RESERV.10/30; HYDROCEPHALUS MANAGEMENT Back to Search Results
Model Number FX157T
Device Problem Infusion or Flow Problem (2964)
Patient Problems Failure of Implant (1924); Patient Problem/Medical Problem (2688)
Event Type  Injury  
Manufacturer Narrative
When additional information becomes available, a follow up report will be submitted.
 
Event Description
It was reported that the valve is blocked.The reporter indicated a post operative valve is blocked.The valve was explanted.Additional event details are not available.
 
Manufacturer Narrative
Investigation visual inspection no significant deformations or damage of the valve were detected during the visual inspection.Permeability test a permeability test has indicated that the valve has a blockage.Adjustment test this is a fixed pressure valve.An adjustment test is not applicable.Braking force and brake function test this is a fixed pressure valve.A braking force and brake function test is not applicable.Results it should be noted that the valve was received dry (i.E.Not submersed in liquid as recommended).The investigation of dry items is not significant due to the affect dry deposits of liquor and blood can have on product performance.In spite of this, we have investigated the valve to the best of our abilities.First, we performed a visual inspection of the gav 2.0.No significant deformations or damage of the valve were detected during the visual inspection.Next, we tested the permeability of the valve.The valve was shown to have a blockage.Finally, we have dismantled the valve.Inside the valve, we have found a build-up of substances (likely protein).Based on our investigation, we confirm the presence of occlusion in the valve, 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 hc-therapy by shunt implants.We can exclude a defect at the time of release.The valve met all specifications of the final inspection when released from christoph miethke gmbh & co.Kg.
 
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Brand Name
GAV 2.0 SYS W/PED.CONTROL RESERV.10/30
Type of Device
HYDROCEPHALUS MANAGEMENT
Manufacturer (Section D)
CHRISTOPH MIETHKE GMBH & CO. KG
2 ulanenweg
potsdam d, 14469
GM  14469
MDR Report Key9270513
MDR Text Key167323588
Report Number3004721439-2019-00277
Device Sequence Number1
Product Code JXG
Combination Product (y/n)N
PMA/PMN Number
K161853
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 11/25/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/02/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberFX157T
Device Catalogue NumberFX157T
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/28/2019
Date Manufacturer Received11/13/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age12 MO
Patient Weight10
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