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

Model Number	31335
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	Perforation of Vessels (2135)
Date of Event	07/06/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Without batch number information nor x-ray pictures, no thorough investigation can be performed and no conclusion can be drawn.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 or Problem Description
"filter was implanted into patient on or about (b)(6) 2014.On (b)(6) 2017, patient underwent a computerized tomography scan ("ct scan") of the chest.Examination of the ct scan by a qualified expert radiologist revealed that the filter is tilted with multiple struts perforating the ivc.".

• Brand Name: VENATECH LP
• Common Device Name: VENA CAVA FILTER
• Manufacturer (Section D): B.BRAUN MEDICAL SAS; 26 rue armengaud; saint cloud, 92210 ; FR 92210
• MDR Report Key: 12239128
• Report Number: 9612452-2021-00034
• Device Sequence Number: 5097232
• 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: 2014
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• 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: 07/21/2021
• Initial Report FDA Received Date: 07/28/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other