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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. DENALI VENA CAVA FILTER FEMORAL; FILTER, INTRAVASCULAR, CARDIOVASCULAR
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BARD PERIPHERAL VASCULAR, INC. DENALI VENA CAVA FILTER FEMORAL; FILTER, INTRAVASCULAR, CARDIOVASCULAR Back to Search Results
Model Number REF DL900F
Device Problems Difficult to Remove (1528); Difficult to Open or Close (2921)
Patient Problem Foreign Body In Patient (2687)
Event Date 08/27/2018
Event Type  Injury  
Event Description
When attempting to deploy ivc filter, struts would not open.It appeared the filter was crimped down like it was still constrained by sheath but it was not.Attempted to retrieve with deployment sheath, but filter became loose.Unable to retrieve filter despite vascular surgeon spending four hours with assistance from a second vascular surgeon and an intervention cardiologist.Filter ended up ascending into right ventricular and into tricuspid valve.Cardiothoracic surgeon suggested pt may need sternotomy to open heart and remove filter.Pt transferred to higher level of care facility-(b)(6).
 
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Brand Name
DENALI VENA CAVA FILTER FEMORAL
Type of Device
FILTER, INTRAVASCULAR, CARDIOVASCULAR
Manufacturer (Section D)
BARD PERIPHERAL VASCULAR, INC.
MDR Report Key7842260
MDR Text Key119206040
Report NumberMW5079532
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 Nurse
Type of Report Initial
Report Date 08/29/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/31/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date06/30/2021
Device Model NumberREF DL900F
Device Lot NumberGFCS25850
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was Device Evaluated by Manufacturer? No Information
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Life Threatening; Required Intervention;
Patient Age26 YR
Patient Weight83
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