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U.S. Department of Health and Human Services

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

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BARD PERIPHERAL VASCULAR, INC. DENALI VENA CAVA FILTER FILTER, INTRAVASCULAR, CARDIOVASCULAR Back to Search Results
Model Number DL900J
Device Problems Fracture (1260); Premature Activation (1484); Difficult to Remove (1528); Device Inoperable (1663); Malposition of Device (2616)
Patient Problem Foreign Body In Patient (2687)
Event Date 04/25/2018
Event Type  Injury  
Event Description

During procedure to insert right internal jugular ivc filter, the filter did not fully deploy. During deployment, the outer leg appropriately deployed but the inner legs remained constrained and nonfunctional. This resulted in the filter tilting. Multiple attempts were made to snare the filter hook which was difficult relative to the tilted position of the filter and it required several snare devices to be utilized before the filter was snared and removed. Upon examination of the removed ivc filter, a fracture of one of the centering legs was noted. Fluoroscopic images were obtained of the chest and abdomen, locating the missing filter leg with embolization in the upper lobe of the pulmonary artery branch. The malpositioned ivc filter and the embolized fractured leg were successfully retrieved/removed using fluoroscopic guidance. A new right internal jugular ivc filter was installed successfully. Pt remained stable throughout the procedure.

 
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Brand NameDENALI VENA CAVA FILTER
Type of DeviceFILTER, INTRAVASCULAR, CARDIOVASCULAR
Manufacturer (Section D)
BARD PERIPHERAL VASCULAR, INC.
tempe AZ 85281
MDR Report Key7475191
MDR Text Key107104473
Report NumberMW5076911
Device Sequence Number1
Product Code DTK
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 04/26/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/30/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date12/31/2019
Device MODEL NumberDL900J
Device Catalogue NumberDL900J
Device LOT NumberGFAY3047
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated By Manufacturer?
Is The Device Single Use?
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient TREATMENT DATA
Date Received: 04/30/2018 Patient Sequence Number: 1
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