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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 Problem Complete Blockage (1094)
Patient Problems Pulmonary Embolism (1498); Thrombosis/Thrombus (4440)
Event Date 03/21/2015
Event Type  Injury  
Manufacturer Narrative
Manufacturing review: a device history record review could not be performed as the lot number is unknown. Investigation summary: the device was not returned for evaluation. Medical records were provided and reviewed. Approximately one year and two months of post deployment, patient presented to the emergency department with the complaints of nausea, vomiting, back pain and trouble breathing. Two days later, a computed tomography angiography of chest was performed for dyspnea. The study showed that presence of acute pulmonary embolism within branch vessels supplying the right upper lobe and right lower lobe. There was some junctional pleural reticular opacity within the right lung base, which probably represents developing pulmonary infarct. Three days later, a computed tomography of lumbar spine was performed for lumbar pain. The study showed that inferior vena cava filter was demonstrated within the course of the inferior vena cava. There was an enhancement of the right and left renal veins, but there was hypoattenuation within the central portion of the inferior vena cava at the level of the renal veins. This may be either secondary to the phase of contrast or there could be an underlying thrombus within the inferior vena cava. Four days later, patient presented with recurrent deep vein thrombosis, pulmonary embolism and totally occluded inferior vena cava filter. A bilateral lower extremity venous doppler study was performed for extensive edema. The study showed that right lower extremity extensive occlusive thrombus in the iliac, common femoral vein, greater saphenous vein, femoral vein, profunda vein, femoral vein and popliteal vein. Nonocclusive thrombus in the peroneal vein. Left lower extremity extensive occlusive thrombus in the iliac, common femoral vein, greater saphenous vein, femoral vein, profunda vein and femoral vein. Nonocclusive thrombus in the popliteal vein. The next day, patient was planned for bilateral lower extremity venography and initiation of catheter directed thrombolysis. An ultrasound of popliteal veins was performed which demonstrated occlusive thrombus within both popliteal veins. Ultrasound guidance puncture of popliteal veins were performed, and sheaths were placed in both popliteal veins. The thrombus was traversed in the right lower extremity and the catheter was advanced into the inferior vena cava above the filter. Digital subtraction venography was performed. There was an extensive occlusive thrombus involving the popliteal common femoral, common femoral and iliac veins. The thrombus extends into the inferior vena cava to the level of the inferior vena cava filter. Ekos catheter was advanced above the inferior vena cava under fluoroscopic guidance. Thrombolysis with tissue plasminogen activator (tpa) was initiated. Therefore, the investigation is confirmed for occlusion of inferior vena cava. Additionally, it can be confirmed that the patient experienced pulmonary embolism and thrombus above the filter post deployment. However, the relationship to the filter is unknown. Based on the available information, the definitive root cause is unknown. Labeling review: a review of product labeling documents (e. G. Procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, and unit label) 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 after being diagnosed with deep vein thrombosis/pulmonary embolism. Approximately one year two months later post filter deployment, patient was diagnosed with thrombus formation, complete inferior vena cava occlusion and pulmonary embolism. 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 NY 12804
Manufacturer Contact
judith ludwig
1415 w. 3rd street
tempe, AZ 85281
4803032689
MDR Report Key11919332
MDR Text Key253701555
Report Number2020394-2021-80476
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 Non-Healthcare Professional
Type of Report Initial
Report Date 06/02/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/02/2021
Is this an Adverse Event Report? Yes
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 Received05/06/2021
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: 06/02/2021 Patient Sequence Number: 1
Treatment
HYDROCODONE-ACETAMINOPHEN AND LORAZEPAM; OLANZAPINE AND ZOLPIDEM
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