MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. DENALI FEMORAL SYSTEM; VENA CAVA FILTER

Catalog Number	DL900F
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	Perforation of Vessels (2135)
Date of Event	08/08/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H11: as the lot number for the device was provided, a review of the device history records will 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 provide 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.
Event or Problem Description
On (b)(6) 2024, a patient underwent a percutaneous inferior vena cava filter implantation using a denali filter.On (b)(6) 2025 during the removal procedure, the filter punctured patients heart which required emergency cardio surgery/repair and transport to another facility.Current status of the patient is unknown.
Event or Problem Description
On (b)(6) 2024, a patient underwent a percutaneous inferior vena cava filter implantation using a denali filter.Post the procedure on (b)(6) 2025, during removal, the filter punctured patient's heart which required emergency cardio surgery/repair and transport to another facility.Furthermore, the hcp attempted to remove the denali ivc filter using a benson wire.While introducing and advancing the sheath through the ivc filter, the sheath buckled.The hcp subsequently realigned the sheath and was able to successfully retrieve the ivc filter.The reporter recanted the allegation of device failure, confirming that the reported issue was associated with a non-bd device.
Additional Manufacturer Narrative
H11: additional information was received.During the procedure, the hcp attempted to remove the denali ivc filter using a benson wire.While introducing and advancing the sheath through the ivc filter, the sheath buckled.The hcp subsequently realigned the sheath and was able to successfully retrieve the ivc filter.The hcp stated that this is all the information available from dr.Tamim.Furthermore, the reporter recanted the allegation of device failure, confirming that the reported issue was associated with a non-bd device, and that there was no deficiency or malfunction with the bd product.Therefore, this report is no longer being considered a complaint file and determined to be no longer reportable.Since an initial mdr was submitted, therefore, the file will remain assessed as a serious injury.B5, g3.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 AZ 85281
• Manufacturer (Section G): C.R. BARD, INC. (GFO); 289 bay road; queensbury 12804
• Manufacturer Contact: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 23678446
• Report Number: 2020394-2025-02043
• Device Sequence Number: 13362449
• Product Code: DTK
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K130366
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/15/2026

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: DL900F
• Device Lot Number: GFJR0198
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/06/2025
• Supplement Date Received by Manufacturer: 06/01/2026
• Initial Report FDA Received Date: 12/01/2025
• Supplement Report FDA Received Date: 06/22/2026
• 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