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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 Problems Malposition of Device (2616); Patient-Device Incompatibility (2682); Patient Device Interaction Problem (4001)
Patient Problem Abdominal Pain (1685)
Event Date 09/04/2018
Event Type  Injury  
Manufacturer Narrative
As the lot number for the device was provided, a review of the device history records will be performed. The device has not been returned to the manufacturer for evaluation. The investigation of the reported event is currently underway. (expiry date: 06/2018).
 
Event Description
It was reported through the litigation process that a vena cava filter was placed in a patient after being diagnosed with morbid obese, bilateral pulmonary emboli and left leg deep vein thrombosis. Approximately three years and one month post filter deployment, a computed tomography (ct) abdomen without intravenous contrast revealed that the filter tilted and struts perforated the inferior vena cava wall. The device was removed percutaneously. The patient reportedly experienced left-sided abdominal pain; 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 NY 12804
Manufacturer Contact
judith ludwig
1415 w. 3rd street
tempe, AZ 85281
4803032689
MDR Report Key11357238
MDR Text Key232782629
Report Number2020394-2021-80181
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,Followup
Report Date 03/09/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/22/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberDL900J
Device Catalogue NumberDL900J
Device Lot NumberGFZE3710
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/03/2021
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: 02/22/2021 Patient Sequence Number: 1
Treatment
BUSPIRONE HYDROCHLORIDE, FUROSEMIDE AND IBUPROFEN; FENOFIBRATE AND LEFLUNOMIDE; LISINOPRIL, LYRICA AND MONTELUKAST SODIUM; PERCOCET, PANTOPRAZOLE SODIUM AND PREDNISONE; XELJANZ, TRAMADOL, LYRICA AND COUMADIN
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