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U.S. Department of Health and Human Services

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

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BARD PERIPHERAL VASCULAR, INC. DENALI JUGULAR SYSTEM VENA CAVA FILTER Back to Search Results
Model Number DL900J
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Thrombosis/Thrombus (4440)
Event Date 06/05/2019
Event Type  Injury  
Manufacturer Narrative
As the lot number for the device was provided, a review of the device history records is currently being performed. The device has not been returned to the manufacturer for evaluation. The investigation of the reported event is currently underway. (expiry date: 10/2021). Device not returned.
 
Event Description
It was reported through the litigation process that a vena cava filter was placed in a patient after being diagnosed with bilateral femoral vein deep vein thrombosis. The device has not been removed and there were no reported attempts made to retrieve the filter. The patient was diagnosed with thrombus above the filter; however, the current status of the patient is unknown.
 
Manufacturer Narrative
The device history records have been reviewed and this lot met all release criteria. There was nothing found to indicate there was a manufacturing related cause for this event. The device was not returned for evaluation. Medical records were provided and reviewed. Two inferior vena cava filters were deployed due to the large size of the inferior vena cava. Approximately, two months twenty-three days, a computed tomography (ct) abdomen and pelvis with intravenous contrast showed that the inferior vena cava filters were identified within the bilateral common iliac veins, at the level of the confluence of external and internal iliac veins on the right and above the level of the confluence of the left. There was no thrombus in the inferior vena cava or common iliac veins. Around, four months and eleven days later, an attempt was made to retrieve the right iliac vein filter from the patient¿s body. A left iliac venogram demonstrated that a large thrombus was associated with the superior tip of the left iliac vein filter, that extended towards the iliac bifurcation. Due to the adherent thrombus, it was not safe to remove the filter at this time. Through a separated right internal jugular venous access, a 6-french sheath was placed over the wire to the level of the right iliac vein inferior vena cava filter. A right external iliac venogram demonstrated there was no evidence of thrombus associated with the filter. Serial dilation was performed, and the coaxial sheath system was advanced into position just cephalad to the apex of the filter. Despite multiple attempts, the filter apex was unable to be engaged with a 20 mm loop snare. Ultimately, a 6 french sheath was placed over the wire to the level of the right inferior vena cava filter. A vs1 catheter was then formed in the right external iliac vein. It was then attempted to sling the filter with a glidewire. During this maneuver, the patient experienced discomfort and it was decided to abort the procedure. The sheaths were removed, and hemostasis was achieved with manual pressure. Therefore, the investigation is inconclusive as no objective evidence has been provided to confirm any alleged deficiency with the filter. Additionally, it can be confirmed that the patient experienced thrombus above the filter post deployment. 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. (expiry date: 10/2021).
 
Event Description
It was reported through the litigation process that a vena cava filter was placed in a patient after being diagnosed with bilateral femoral vein deep vein thrombosis. The device has not been removed and there were no reported attempts made to retrieve the filter. The patient was diagnosed with thrombus above the filter; however, the current status of the patient is unknown.
 
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Brand NameDENALI JUGULAR 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 Key11874999
MDR Text Key252346812
Report Number2020394-2021-01100
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 company representative,consum
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/26/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/25/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberDL900J
Device Catalogue NumberDL900J
Device Lot NumberGFCW0246
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/26/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/06/2018
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: 05/25/2021 Patient Sequence Number: 1
Treatment
APIXABAN
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