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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO. KG PROGAV VALVE HYDROCEPHALUS VALVES

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CHRISTOPH MIETHKE GMBH & CO. KG PROGAV VALVE HYDROCEPHALUS VALVES Back to Search Results
Model Number FV410T
Device Problem Infusion or Flow Problem (2964)
Patient Problems Failure of Implant (1924); Hydrocephalus (3272)
Event Date 11/02/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Patient height: 160 cm. 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 valve was explanted due to a malfunction. A (b)(6) year old patient underwent a shunt system implantation on (b)(6) 2014. After 4. 5 years, it was noted that the valve was no longer adjustable and overdrainage occurred. 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. Scratches and a slight deformation of the outer housing of the progav was observed through the visual inspection. The progav housing was subsequently measured and confirmed the presences of a deformation. The housing deformation measured at -0. 0725mm, outside the tolerance of 0 +/- 0. 02mm. A permeability test has shown that the progav is permeable. The progav was tested and is not adjustable throughout the normal range. 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. To test the opening pressure, we use a miethke computer controlled testing apparatus which simulates a cerebrospinal fluid flow. The progav is not operating within the acceptable tolerances. We have dismantled the valve. Inside the valve we have found a significant build-up of substances (likely protein). Based on our investigation, we confirm that the valve is non-adjustable and operating in a state of over-drainage, likely due to the deposits observed inside the valve and the deformation of the outer housing. As described in our 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 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.
 
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Brand NamePROGAV VALVE
Type of DeviceHYDROCEPHALUS VALVES
Manufacturer (Section D)
CHRISTOPH MIETHKE GMBH & CO. KG
2 ulanenweg
potsdam d, 14469
GM 14469
MDR Report Key8126726
MDR Text Key129152617
Report Number3004721439-2018-00287
Device Sequence Number1
Product Code JXG
Combination Product (y/n)N
PMA/PMN Number
K103003
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 Expiration Date12/31/2018
Device Model NumberFV410T
Device Catalogue NumberFV410T
Device Lot Number4505674591
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/05/2018
Was the Report Sent to FDA?
Distributor Facility Aware Date12/03/2018
Device Age57 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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