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

Model Number 5010024

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

Patient Problem Insufficient Information (4580)

Event Date 03/09/2017

Event Type  Injury  

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 october 2004.Investigation results we did not receive the x-ray pictures or detailed information for investigation.No information is given to explain why the filter was retrieve whereas the venatech lp filter is a permanent filter and is not retrievable.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 the case.

Event Description

"filter was implanted in patient on or about (b)(6) 2005 at (b)(6).On (b)(6) 2017, patient underwent iliocaval recanalization with stenting and a complex filter retrieval at (b)(6).".

• Brand Name: VENATECH LP
• Type of Device: VENA CAVA FILTER
• 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: 12239127
• MDR Text Key: 263854659
• Report Number: 9612452-2021-00033
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K010485
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 10/11/2009
• Device Model Number: 5010024
• Device Catalogue Number: 5010024
• Device Lot Number: F0624410
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/21/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/12/2004
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention