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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 Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Thrombosis/Thrombus (4440)
Event Date 02/04/2015
Event Type  Injury  
Manufacturer Narrative
Manufacturing review: the 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, twenty-eight days of post deployment, computed tomography angiogram of chest with contrast was performed which demonstrated that there was partial visualization of an infrarenal inferior vena cava filter with a 1. 6 x 1. 6 cm thrombus surrounded and cephalad to the apex of the filter. After, six days, venogram showed that there was complete occlusive acute thrombosis of the inferior vena cava from its bifurcation up to and through the level of the infrarenal filter. On the next day, there was a significant thrombus within the apex of the filter. Around one year and five months later, filter retrieval was attempted. Axis was obtained through the internal jugular on the right side and a bard removable system was advanced into the area of the filter. The filter was tract and after multiple manipulations the filter was able to remove entirely. The inferior vena cava filter was removed successfully. Around, one year and six months later, computed tomography angiogram of chest with contrast was performed and the result showed that there was no evidence of pulmonary embolism. There were no device deficiencies identified within the medical records. 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. However, the relationship to the filter is unknown. Based upon 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 and pulmonary embolism. At some time, post filter deployment, a computed tomography (ct) revealed that there was a thrombus surrounded and cephalad to the apex of the filter. The device was removed percutaneously. 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
MDR Report Key12737230
MDR Text Key279567055
Report Number2020394-2021-80797
Device Sequence Number1
Product Code DTK
UDI-Device Identifier00801741040801
UDI-Public(01)00801741040801
Combination Product (y/n)N
PMA/PMN Number
K130366
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,health professional
Type of Report Initial
Report Date 11/02/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/02/2021
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
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/04/2021
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: 11/02/2021 Patient Sequence Number: 1
Treatment
DIAZEPAM, HYDROMORPHONE, METOPROLOL; MORPHINE, NORTRIPTYLINE, ZANAFLEX; TRAMADOL, WARFARIN, FLEXERIL AND LOVENOX
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