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

Model Number	5010024
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Spinal Column Injury (2081); Great Vessel Perforation (2152); Bowel Perforation (2668)
Date of Event	03/26/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Venatech lp filter implanted into patient on or about (b)(6) 2004 after being diagnosed with dvt and pe.On or about (b)(6) 2021 patient underwent a computerized tomography scan of his abdomen.Examination by a qualified expert radiologist showed multiple struts perforations through wall of his inferior vena cava with one strut abutting the duodenum, it also showed a strut in contact with a vertebral body causing a bony reaction.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 type of incident is very rare.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: 15692028
• Report Number: 9612452-2022-00050
• Device Sequence Number: 6763854
• 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: 10/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown