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U.S. Department of Health and Human Services

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

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B.BRAUN MEDICAL SAS VENATECH LP VENA CAVA FILTER SYSTEM Back to Search Results
Model Number 31335
Device Problem Insufficient Information (3190)
Patient Problem Thromboembolism (2654)
Event Date 01/19/2017
Event Type  Injury  
Manufacturer Narrative

Without x-ray pictures, batch number nor detailed information, no thorough investigation can be performed. No conclusion can be drawn about the event root cause. If new elements become available in the future, we will update this case. It is worth noting that thromboembolism is a known potential adverse events associated with all ivc filters and listed in the ifu. The current adverse event rate for similar incident on venatech lp is very low. No action is envisaged.

 
Event Description

"filter was implanted into patient on or about (b)(6) 2015. On (b)(6) 2017, patient underwent venous surgery. A venography was performed. The braun vena tech ivc filter was occluded. A catheter placement procedure was also performed in the ivc along with ivc angioplasty and stenting. On (b)(6) 2017, patient underwent a computed tomography scan (ct scan). Examination of the ct scan by a qualified expert radiologist revealed that the filter was pressed against the right lateral sidewall of the ivc by a stent. ".

 
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Brand NameVENATECH LP
Type of DeviceVENA CAVA FILTER SYSTEM
Manufacturer (Section D)
B.BRAUN MEDICAL SAS
26 rue armengaud
saint cloud, 92210
FR 92210
Manufacturer (Section G)
B.BRAUN MEDICAL SAS FRANCE
30 avenue des temps modernes
chasseneuil du poitou 86360
FR 86360
Manufacturer Contact
catherine boismenu
30 avenue des temps modernes
chasseneuil du poitou, 86360
FR   86360
MDR Report Key12376906
MDR Text Key268443558
Report Number9612452-2021-00042
Device Sequence Number1
Product Code DTK
Combination Product (Y/N)N
PMA/PMN NumberK010485
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type OTHER
Type of Report Initial
Report Date 08/26/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/27/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator NO INFORMATION
Device MODEL Number31335
Device Catalogue Number5010024
Was Device Available For Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/06/2021
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 08/27/2021 Patient Sequence Number: 1
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