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

Model Number	31335
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Perforation of Vessels (2135)
Date of Event	10/20/2017
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) 2006.On (b)(6) 2017, patient underwent a computerized tomography scan ("ct scan") of the abdomen.Examination of the ct scan by a qualified expert radiologist revealed that the filter was tilted with multiply struts perforating beyond the ivc wall.".

• 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: 12376901
• Report Number: 9612452-2021-00039
• Device Sequence Number: 14434182
• Product Code: DTK
• UDI-Device Identifier: 04038653918164
• UDI-Public: 04038653918164
• Combination Product (Y/N): N
• PMA/510(K) Number: K010485
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 08/26/2021

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?: Yes
• Operator of Device: No Information
• Device Model Number: 31335
• Device Catalogue Number: 5010024
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/30/2021
• Initial Report FDA Received Date: 08/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Disability