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

Model Number 31335

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Perforation of Vessels (2135)

Event Date 10/19/2017

Event Type  Injury  

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 Description

"the filter was implanted into patient on or about (b)(6) 2009.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 distal filter prongs were perforating through the ivc.Two prongs are abutting the abdominal aorta.".

• Brand Name: VENATECH LP
• Type of Device: VENA 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 Key: 12376894
• MDR Text Key: 268443113
• Report Number: 9612452-2021-00038
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 04038653918164
• UDI-Public: 04038653918164
• Combination Product (y/n): N
• PMA/PMN Number: K010485
• Number of Events Reported: 1
• 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 Received: 08/27/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 31335
• Device Catalogue Number: 5010024
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/30/2021
• 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: N
• Patient Sequence Number: 1
• Patient Outcome(s): Disability