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

Model Number	31335
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Thromboembolism (2654)
Date of Event	01/19/2017
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• 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: 12376906
• Report Number: 9612452-2021-00042
• Device Sequence Number: 19814412
• 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?: No
• 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: 08/06/2021
• 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: Hospitalization; Required Intervention