MAUDE Adverse Event Report: B. BRAUN MEDICAL VENA TECH; FILTER, INTRAVASCULAR, CAR

Model Number	5010024
Medical Device Problem Codes	Break (1069); Migration or Expulsion of Device (1395)
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
This report has been identified as b.Braun medical internal report number (b)(4).As reported by the user facility: 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.

• Brand Name: VENA TECH
• Common Device Name: FILTER, INTRAVASCULAR, CAR
• Manufacturer (Section D): B. BRAUN MEDICAL; 30 avenue des temps modernes; chasseneuil-du-poitou vienne, 86360 ; FR 86360
• MDR Report Key: 15583866
• Report Number: 3006332832-2022-00004
• Device Sequence Number: 5978692
• Product Code: DTK
• UDI-Device Identifier: 04038653918164
• UDI-Public: (01)04038653918164
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/11/2022
• Report Date (Section F): 10/11/2022

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
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 09/30/2022
• Event Location: Hospital
• Date Report to Manufacturer: 10/11/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/11/2022
• 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: Other
• Patient Sex: Male
• Date Report Sent to FDA: 10/11/2022