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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); Migration (4003)
Patient Problem Abdominal Pain (1685)
Event Date 09/06/2018
Event Type  Injury  
Manufacturer Narrative
A device history record review could not be performed as the lot number is unknown. Investigation summary: the device was not returned for evaluation. The medical records included images. The image review was documented in the medical records. Medical records were provided and reviewed. After one week post deployment, the patient presented with abdominal pain. After two days, a computed tomography (ct) chest without contrast demonstrated that an inferior vena cava filter was partially visualized. On the next day, a duplex venous leg bilateral showed no evidence of deep vein thrombosis of the veins of the legs. After two years and two weeks later, a computed tomography (ct) abdomen without intravenous or oral contrast showed that there was a vena cava filter and this was tipped approximately 20-degrees medially. The superior aspect of the filter was at the level of the left renal vein superiorly. One of the struts at 9 o¿ clock was 3 mm beyond the wall of the vena cava. One of the struts at 11 o¿ clock was approximately 2 mm beyond the vena cava. None of the struts appeared to extend into adjacent organs. There was no retroperitoneal hematoma. There was no fracture or bending of the struts identified. Therefore, the investigation is confirmed for the alleged filter migration, perforation of the inferior vena cava and filter tilt. 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/pulmonary embolism. Approximately two years post vena cava filter deployment a computed tomography scan demonstrated that the filter tilted and perforated. At some time post filter deployment, it was alleged that the filter migrated. 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 Key12201521
MDR Text Key262623893
Report Number2020394-2021-80665
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 07/21/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/21/2021
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 Received06/24/2021
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: 07/21/2021 Patient Sequence Number: 1
Treatment
MUCINEX, VISTARIL, LEVAQUIN AND PANTOPRAZOLE; PREDNISONE AND DAPTOMYCIN; TYLENOL, DIPHENHYDRAMINE, LOVENOX AND GABAPENTIN
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