MAUDE Adverse Event Report: Bard Peripheral Vascular, Inc. Denali Femoral System; Vena Cava Filter

Catalog Number	DL900F
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/03/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
A patient underwent a percutaneous inferior vena cava (ivc) filter implantation procedure using a denali filter via femoral vein access.During the procedure, it was reported that the filter had allegedly migrated from its intended position.It was further reported that two attempts were made to retrieve the denali filter; however, the retrieval attempts were unsuccessful.Subsequently, another physician ordered an abdominal mri for further evaluation.The patient's current status is unknown.
Additional Manufacturer Narrative
H11: b3.The date received by manufacturer has been used for this field.As the lot number for the device was not provided, a review of the device history records could not be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.Section a through f: the information provided by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant/reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.

• Brand Name: Denali Femoral System
• Common Device Name: Vena Cava Filter
• Manufacturer (Section D): Bard Peripheral Vascular, Inc.; 1625 w 3rd st.; tempe 85281
• Manufacturer (Section G): C.R. Bard, Inc. (GFO); 289 bay road; queensbury 12804
• Manufacturer Contact: michael gaffney ; 800 w. rio salado pkwy; tempe, AZ 85281 ; +1(480)303-2689
• MDR Report Key: 50910808
• Report Number: 2020394-2026-02837
• Device Sequence Number: 14897050
• Product Code: DTK
• UDI-Device Identifier: 00801741040801
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K130366
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/07/2026

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: Health Professional
• Device Catalogue Number: DL900F
• Device Lot Number: Unknown
• 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: 09/03/2026
• Initial Report FDA Received Date: 09/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Required Intervention
• Patient Sex: Unknown