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	08/04/2014
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch history review: we have checked the manufacturing file of the involved batch which complies with our specifications and does not present any discrepancy.No other similar complaint has been reported to us on this batch of vena cava filters released in january 2010.Investigation results we did not receive the x-ray pictures or detailed information for investigation.Conclusion without concrete element, no thorough investigation can be performed.A causality link between the device and the reported event cannot be established.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 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) 2010.On or about (b)(6) 2014, patient underwent a computerized tomography scan ("ct scan") of the abdomen.On (b)(6) 2017, a review of the (b)(6) 2014, ct scan was preformed, revealing multiple struts penetrating the ivc wall.".

• 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: 12239131
• Report Number: 9612452-2021-00035
• Device Sequence Number: 5097828
• 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: 2010
• 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 Expiration Date: 11/30/2014
• Device Model Number: 31335
• Device Catalogue Number: 5010024
• Device Lot Number: I349273V
• 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