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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 Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Perforation of Vessels (2135)
Event Date 04/03/2017
Event Type  Injury  
Manufacturer Narrative

Batch history review: we have checked the manufacturing file of the involved batch which complies with our specifications and does not present any discrepancy. No other similar complaint has been reported to us on this batch of vena cava filters released in february 2004. Investigation results: we did not receive the x-ray pictures or detailed information for investigation. Conclusion without concrete element, no thorough investigation can be performed. A causality link between the device and the reported event cannot be established. 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 ivc perforation is a known potential adverse event associated with all ivc filters and listed in the ifu. The current ivc perforation rate for venatech lp is very low. No action is envisaged.

 
Event Description

"filter was implanted into patient on (b)(6) 2004. On (b)(6) 2015, patient underwent a ct scan of the abdomen and pelvis. At that time the radiologist reading the images reported the presence of an ivc filter but gave no further description. The ct scan images were reviewed by another radiologist on (b)(6) 2017 and for the first time it was noted that the vena tech ivc filter had perforated thru the vena cava wall. More specifically, the radiologist found: the left anterolateral and right posterolateral struts have penetrated through the ivc wall. ".

 
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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 Key12376896
MDR Text Key268443285
Report Number9612452-2021-00040
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? Yes
Device Operator NO INFORMATION
Device EXPIRATION Date12/31/2008
Device MODEL Number31335
Device Catalogue Number5010024
Device LOT NumberF0535260
Was Device Available For Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/02/2021
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured01/17/2011
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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