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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO. KG PROGAV 2.0 WITH SHUNTASSISTANT 25 HYDROCEPHALUS VALVES

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CHRISTOPH MIETHKE GMBH & CO. KG PROGAV 2.0 WITH SHUNTASSISTANT 25 HYDROCEPHALUS VALVES Back to Search Results
Model Number FX414T
Device Problem Obstruction of Flow (2423)
Patient Problems Failure of Implant (1924); Hydrocephalus (3272)
Event Date 10/21/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Manufacturing site evaluation: investigation on-going. Additional information / investigation results will be provided in a supplemental report.
 
Event Description
It was reported that a progav shunt system was explanted due to a malfunction. A (b)(6) patient underwent a shunt system implantation on (b)(6) 2018. After 1 month, it was noted that the valve was blocked. This issue led to explantation of the device. Further details have been requested but not yet received.
 
Manufacturer Narrative
All parameters have been inspected and approved during the manufacturing process. All parameters have been assessed as meeting specifications. No significant deformations or damages of the valves were detected during the visual inspection. A permeability test has indicated that the shunt assistant has a blockage and the progav 2. 0 valve is permeable. The progav 2. 0 valve was tested and is adjustable to all specified pressures. The brake functionality test has shown that the brake function is fully operational and the braking force is within the given tolerances. We have dismantled the valves. Inside both valves we have found a build up of substances (likely protein). Based on our investigation, we confirm the presence of occlusion in the shunt assistant, likely due to the deposits observed in the valve. The deposits observed inside the progav 2. 0 might also have contributed to the malfunction in the past. As described in out literature, the problem encountered is one of the known, inevitable risks of hc- therapy by shunt implants.
 
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Brand NamePROGAV 2.0 WITH SHUNTASSISTANT 25
Type of DeviceHYDROCEPHALUS VALVES
Manufacturer (Section D)
CHRISTOPH MIETHKE GMBH & CO. KG
2 ulanenweg
potsdam d, 14469
GM 14469
MDR Report Key8126736
MDR Text Key129147603
Report Number3004721439-2018-00286
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 12/20/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/03/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberFX414T
Device Catalogue NumberFX414T
Device Lot Number20036567
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/05/2018
Was the Report Sent to FDA?
Distributor Facility Aware Date11/26/2018
Device Age7 MO
Event Location No Information
Date Manufacturer Received12/03/2018
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 12/03/2018 Patient Sequence Number: 1
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