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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: B. BRAUN MEDICAL SAS VENATECH LP VENA VACA FILTER PERMANENT VENA CAVA FILTER

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B. BRAUN MEDICAL SAS VENATECH LP VENA VACA FILTER PERMANENT VENA CAVA FILTER Back to Search Results
Model Number 31335
Device Problems Entrapment of Device (1212); Difficult to Open or Close (2921)
Patient Problem Death (1802)
Event Date 01/19/2015
Event Type  Injury  
Event Description

"the filter did not expand. The surgeon tried to remove it by the same route, femoral, with devices from unit angioplasty. Six hours were necessary to open the patient to remove it directly from the inferior vena cava. The filter expanded after removal. Following this, another venatech lp filter was placed without problem. The patient died the day after, on (b)(6) 2015. ".

 
Manufacturer Narrative

Evaluation summary. Visual examination: the filter received for evaluation seems to have been partially cleaned before shipment. Some blood contamination is still visible but no trace of tissue was found around the filter. The filter shape is normal. Its geometry is slightly modified compared to our specifications. However this could be explained by the fact that the filter was distorted during the explanation procedure. Functional test: ability of the filter to open when released was tested: the result is compliant with our requirement. X-ray pictures analysis: the x-ray pictures received allow to see: - that the filter was released at the level of l2-l3, - that after release, the filter remained totally closed and did not move. No cavography was available for analysis. No observation on the patency of the ivc can be performed. Examination of the received photo: the forwarded photo shows the filter just after explanation with a lot of thrombus or tissue along the length of the filter. However we cannot determine precisely, with just this photo, if it is tissue, fibrin or thrombus. These elements confirm that the filter was maintained closed by external element such as tissue, fibrin or thrombus. Conclusion: the evaluation of the explanted filter did not detect any defect of the device. The opening force of the involved filter is compliant with our requirement. The photo taken just after the filter removal shows that the filter was surrounded by human material preventing its deployment. Consequently, we can conclude that the event is not due to device failure. This is an isolated case, no corrective action is envisaged. This type of event is very rare but it is a known complication of the implantation of vena cava filters.

 
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Brand NameVENATECH LP VENA VACA FILTER
Type of DevicePERMANENT VENA CAVA FILTER
Manufacturer (Section D)
B. BRAUN MEDICAL SAS
boulogne
FR
Manufacturer Contact
avenue des temps modernes
chasseneuil, cedex 
49627621
MDR Report Key4531900
MDR Text Key5542750
Report Number9612452-2015-00004
Device Sequence Number1
Product Code DTK
Combination Product (Y/N)N
Reporter Country CodeCI
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other
Reporter Occupation
Remedial Action Other
Type of Report Initial
Report Date 02/10/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/12/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL Number31335
Device Catalogue Number4435125
Device LOT NumberL108426S
Was Device Available For Evaluation? Yes
Date Returned to Manufacturer01/20/2015
Is The Reporter A Health Professional? Yes
Date Manufacturer Received01/12/2016
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured05/01/2012
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 02/12/2015 Patient Sequence Number: 1
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