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

Model Number 31335

Device Problem Insufficient Information (3190)

Patient Problem Thromboembolism (2654)

Event Date 01/19/2017

Event Type  Injury  

Manufacturer Narrative

Without x-ray pictures, batch number nor detailed information, no thorough investigation can be performed.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 thromboembolism is a known potential adverse events associated with all ivc filters and listed in the ifu.The current adverse event rate for similar incident on venatech lp is very low.No action is envisaged.

Event Description

"filter was implanted into patient on or about (b)(6) 2015.On (b)(6) 2017, patient underwent venous surgery.A venography was performed.The braun vena tech ivc filter was occluded.A catheter placement procedure was also performed in the ivc along with ivc angioplasty and stenting.On (b)(6) 2017, patient underwent a computed tomography scan (ct scan).Examination of the ct scan by a qualified expert radiologist revealed that the filter was pressed against the right lateral sidewall of the ivc by a stent.".

• 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: 12376906
• MDR Text Key: 268443558
• Report Number: 9612452-2021-00042
• 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?: Yes
• 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: 08/06/2021
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention