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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO. KG PROGAV W/SHUNTASSIST.20 + DIST.CATH.; HYDROCEPHALUS MANAGEMENT

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CHRISTOPH MIETHKE GMBH & CO. KG PROGAV W/SHUNTASSIST.20 + DIST.CATH.; HYDROCEPHALUS MANAGEMENT Back to Search Results
Model Number FV420T
Device Problem Infusion or Flow Problem (2964)
Patient Problems Failure of Implant (1924); Patient Problem/Medical Problem (2688)
Event Date 09/04/2019
Event Type  Injury  
Manufacturer Narrative
Height: 120cm.When additional information becomes available, a follow up report will be submitted.
 
Event Description
It was reported that the valve was not adjustable and over drains.The reporter indicated that a 6 year 7 month post-operative valve is not adjustable and over drains requiring explanation.Additional details of the event are not available.
 
Manufacturer Narrative
Investigation: visual inspection a slightly deformation of the outer housing of the progav valve was observed through the visual inspection.The progav valve housing was subsequently measured and indicated/confirmed the presence of a deformation.The housing deformation measured at -0.073 mm, outside the tolerance of 0 ± 0.02 mm.Permeability test a permeability test has shown that both valves are permeable.Adjustment test the progav valve was tested and is not adjustable throughout the normal range.Braking force and brake function test the brake functionality test has shown that the brake function is operational, however the braking force cannot be measured due to the non-adjustability of the valve.Computer controlled test to investigate the claim of over-drainage, the opening pressure is measured using a miethke computer controlled testing apparatus, which simulates a cerebrospinal fluid flow.The progav is not operating within acceptable tolerances; the shunt assistant is operating within acceptable tolerances.Results first, we performed a visual inspection of the progav shunt system.A deformation of the outer housing of the progav valve was observed through the visual inspection.The deformation was confirmed through a measurement of the parallelity of the valve housing.Next, we tested the permeability and opening pressure of the valves.The progav was permeable but the opening pressure was not within tolerance.The shunt assistant valve was permeable and the opening pressure was within tolerance.The opening pressure of the progav was significantly lower than expected, indicating a tendency towards over-drainage.Additionally, we tested the adjustability as well as the brake functionality and brake force of the progav valve.The valve was not adjustable to all settings.The brake functionality was fully operational, however due to the inability of the valve to hold a set pressure, it was not possible to measure the brake force.Finally, we have dismantled the valves.Inside both valves, we have found build-up of substances (likely protein).Based on our investigation, we confirm that the progav valve was non-adjustable and the progav operates in over- drainage at the time of our investigation.This is likely due to the deposits observed inside the valves.As described in scientific literature, the problem encountered is one of the known, inevitable risks of hc-therapy by shunt implants.The cause of the deformation of the progav valve and the resultant defect of the rotor could not be determined through our investigation.Significant outside pressure, for example by too much force from the progav adjustment tool or by a fall or impact to the head of the patient, can compromise the integrity of the valve.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 gmbh & co.Kg.
 
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Brand Name
PROGAV W/SHUNTASSIST.20 + DIST.CATH.
Type of Device
HYDROCEPHALUS MANAGEMENT
Manufacturer (Section D)
CHRISTOPH MIETHKE GMBH & CO. KG
2 ulanenweg
potsdam d, 14469
GM  14469
MDR Report Key9145719
MDR Text Key162110000
Report Number3004721439-2019-00245
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 10/09/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/02/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date10/31/2017
Device Model NumberFV420T
Device Catalogue NumberFV420T
Device Lot Number4504597033
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/09/2019
Date Manufacturer Received09/24/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age9 YR
Patient Weight28
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