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U.S. Department of Health and Human Services

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

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BARD PERIPHERAL VASCULAR, INC. DENALI FEMORAL SYSTEM VENA CAVA FILTER Back to Search Results
Model Number DL900F
Device Problems Malposition of Device (2616); Patient Device Interaction Problem (4001)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/16/2019
Event Type  malfunction  
Manufacturer Narrative
Manufacturing review: a manufacturing review was not requested as the lot number reported as unknown. Investigation summary: the device was not returned for evaluation. Medical records were provided and reviewed. Approximately, two years four months of post deployment, computed tomography of the abdomen was revealed the filter was present within the inferior vena cava. There was slight tilt of the filter with the apex abutted against the posterior wall of the inferior vena cava. The apex of the filter was 2-3 cm below the level of the renal veins. The structures of the filter project beyond the wall of the vena cava minimally about 1-2 mm. No impaction upon adjacent structures. No evidence of filter fracture. Therefore, the investigation is confirmed for the perforation of the inferior vena cava (ivc) and filter tilt. The definitive root cause could not be determined based upon available information. Labeling review: the review of the instructions for use, indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.
 
Event Description
It was reported through the litigation process that a vena cava filter was placed in a patient with deep vein thrombosis and contraindication to anticoagulation. Approximately two years and four months post filter deployment, it was alleged that the filter tilted, and struts perforated. The device has not been removed and there were no reported attempts made to retrieve the filter. The current status of the patient is unknown.
 
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Brand NameDENALI FEMORAL SYSTEM
Type of DeviceVENA 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
judy ludwig
800 w. rio salado pkwy
tempe, AZ 85281
4803032689
MDR Report Key12015187
MDR Text Key256685888
Report Number2020394-2021-01219
Device Sequence Number1
Product Code DTK
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K130366
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,health professional
Reporter Occupation
Type of Report Initial
Report Date 06/11/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/17/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberDL900F
Device Catalogue NumberDL900F
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/07/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 06/17/2021 Patient Sequence Number: 1
Treatment
BENADRYL, ATIVAN, NARCAN, PROTONIX.; ZOFRAN, PANTOPRAZOLE, AND LORAZEPAM.
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