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

Model Number	31335
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	Perforation of Vessels (2135)
Date of Event	08/04/2014
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Without concrete element nor batch involved, 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.B.Braun medical sas is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.The reported incident has not been substantiated by any verifiable information (e.G.Films or medical records) that could be used to investigate the veracity of the alleged incident or relation to the device or procedure.This report does not constitute an admission or conclusion by b.Braun medical sas or its employees that the device, b.Braun medical sas, or its employees caused or contributed to the event described in the report.This statement should be included with any information or report disclosed to the public under the freedom of information act.
Event or Problem Description
"filter was implanted into patient on or about (b)(6) 2010.On (b)(6) 2018, patient underwent a computerized tomography scan ("ct scan") of the chest.Examination of the ct scan by a qualified expert radiologist revealed perforation of one (1) of the left legs of the filter, extending approximately 4 mm outside the margin of the ivc.".
Additional Manufacturer Narrative
In the initial report, the model#, the catalog " and the udi # were given while it is unknow which filter was implanted.This information should not be taken into account.
Event or Problem Description
"filter was implanted into patient on or about (b)(6), 2010.On (b)(6), 2018, patient underwent a computerized tomography scan ("ct scan") of the chest.Examination of the ct scan by a qualified expert radiologist revealed perforation of one (1) of the left legs of the filter, extending approximately 4 mm outside the margin of the ivc.".

• Brand Name: VENATECH LP
• Common Device Name: VENA CAVA FILTER SYSTEM
• Manufacturer (Section D): B.BRAUN MEDICAL SAS; 26 rue armengaud; saint cloud, 92210 ; FR 92210
• MDR Report Key: 12239137
• Report Number: 9612452-2021-00036
• Device Sequence Number: 20108128
• Product Code: DTK
• UDI-Device Identifier: 04038653918164
• UDI-Public: 04038653918164
• Combination Product (Y/N): Y
• Initial Reporter Country: US
• PMA/510(K) Number: K010485
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: No Information
• Device Model Number: 31335
• Device Catalogue Number: 5010024
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/22/2021
• Supplement Date Received by Manufacturer: 07/22/2021
• Initial Report FDA Received Date: 07/28/2021
• Supplement Report FDA Received Date: 08/25/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other