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

Model Number DL900F

Device Problems Material Fragmentation (1261); Migration or Expulsion of Device (1395)

Patient Problem Foreign Body In Patient (2687)

Event Date 05/18/2022

Event Type  Injury  

Event Description

Bard denali ivc filter placed uneventfully in (b)(6) 2022.Retrieved via percutaneous access (b)(6) 2022.After retrieval of the filter, it was apparent that there was additional metal remaining in the vena cava.It was mobile, migrating to the junction of the superior vena cava and right atrium before eventual snare retrieval.On examination, this metallic piece did not appear to be part of the ivc filter; i believe it may have been part of the delivery system (which is designed to place the filter but not remain in the patient; the design of this should have made it very securely fixed to the rest of the delivery system to eliminate the possibility of it being retained in the patient, as in this case).No adverse patient impact.Fda safety report id# (b)(4).

• Brand Name: BARD DENALI VENA CAVA FILTER, FEMORAL APPROACH
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.
• MDR Report Key: 14565964
• MDR Text Key: 293160712
• Report Number: MW5110007
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DL900F
• Device Catalogue Number: DL900F
• Device Lot Number: GFDS1043
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/31/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 78 YR
• Patient Sex: Male
• Patient Weight: 71 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White