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

Model Number	5010024
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Codes	Failure of Implant (1924); Foreign Body In Patient (2687)
Date of Event	01/18/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Venatech lp filter implanted into patient on or about (b)(6), 2011 after being diagnosed with deep vein thrombosis ('dvt) and pulmonary embolui ('pe').On or about (b)(6), 2022 patient underwent diagnostic imaging.Examination of the imaging by a qualified expert radiologist showed multiple struts fractured in the vicinity of the lower thoracic spine.Patient is at risk for future migrations, fractures and perforations from the retained venatech lp filter, and faces numerous health risks, including the risk of death.Patient will require ongoing medical care and monitoring for the rest of his life.It should be noted the actual product code was not listed in the document and a batch number was not provided to assist in verify the actual product code.The product code used is the code for the vena tech lp filter as listed in the document.
Additional Manufacturer Narrative
Batch history review: batch unknwon.Investigation: the device is not available for evaluation.No x-ray pictures sent for examination.Conclusion: without any element, no thorought investigation is possible the complaint database has been reviewed for the last 6 years.This is an isolated incident.No corrective action is currently envisaged.

• 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
• 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: 15694848
• Report Number: 9612452-2022-00051
• Device Sequence Number: 12587810
• Product Code: DTK
• UDI-Device Identifier: 04038653918164
• UDI-Public: 04038653918164
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• 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: User Facility,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/28/2022

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 5010024
• Device Catalogue Number: 5010024
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/30/2022
• Initial Report FDA Received Date: 10/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown