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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: C.R. BARD, INC. DENALI; VENA CAVA FILTER
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C.R. BARD, INC. DENALI; VENA CAVA FILTER Back to Search Results
Catalog Number DL900J
Device Problems Difficult or Delayed Positioning (1157); Migration or Expulsion of Device (1395)
Patient Problem No Information (3190)
Event Date 12/24/2016
Event Type  Injury  
Event Description
The denali jugular approach filter did not open all the way.The patient safety report stated: jugular approach ivc filter placement procedure.The device was delivered into the patient and failed to deploy properly, thus migrated within the inferior vena cava and thus had to be immediately retrieved.The device being partially open tilted into the right renal vein as it migrated causing retrieval to be highly difficult.The situation required the sheath to be upsized and substantial amount of extra supplies used to complete the retrieval process.
 
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Brand Name
DENALI
Type of Device
VENA CAVA FILTER
Manufacturer (Section D)
C.R. BARD, INC.
289 bay rd.
queensbury NY 12804
MDR Report Key6215425
MDR Text Key63626833
Report Number6215425
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 User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 12/28/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/30/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Physician
Device Expiration Date08/31/2019
Device Catalogue NumberDL900J
Device Lot NumberGFAV0675
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA12/28/2016
Device Age1 DY
Event Location Hospital
Date Report to Manufacturer12/28/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Treatment
NO
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age22 YR
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