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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 Difficult to Remove (1528); Detachment of Device or Device Component (2907); Patient Device Interaction Problem (4001)
Patient Problem Cardiac Perforation (2513)
Event Date 04/07/2015
Event Type  Injury  
Manufacturer Narrative
Manufacturing review: the device history records have been reviewed with special attention to the raw materials, subassemblies, manufacturing process, and quality control testing. This lot met all release criteria. There was nothing found to indicate there was a manufacturing related cause for this event. Investigation summary: the device was not returned for evaluation. Medical records were provided and reviewed. Bard denali retrievable filter was deployed immediately below the level of the renal veins in a patient with deep vein thrombosis. Approximately one year and two months of post deployment, the patient underwent inferior vena cava filter removal. Access was gained via internal jugular vein. An 018 wire was then advanced into the right atrium under fluoroscopic guidance into dermatomy incision was made. The needle was exchanged for a micropuncture catheter. The inner portion of the catheter and the wire were removed and an amplatz wire was advanced into the inferior vena cava using a 5 french jb 1 catheter for guidance. The jb 1 catheter was removed, and a dilator was placed over the amplatz wire. Following this, a 10 french sheath was advanced over the amplatz wire below the level of the inferior vena cava filter. A hand-injection digital subtraction inferior vena cava gram was performed which demonstrated a widely patent inferior vena cava. There was good position and orientation of the filter without evidence of clot. Several attempts to snare the apex of the filter with a traditional gooseneck's snare were unsuccessful. Therefore, forceps were used to grab the apex of the filter and manipulate the apex into the 10 french sheath. The filter was then removed through the 10 french sheath successfully. Around ten months later, computerized tomography-chest without contrast showed that the linear high attenuation structure within the left atrium which extends into the right atrium, likely through a patent foramen ovale. This likely reflects a foreign body, possibly from a fractured inferior vena cava filter fragment. A foreign object from fractured inferior vena cava filter fragment was found incidentally in patient heart through computerized tomography scan. An inferior vena cava filter placed two years earlier and removed about one year later without noted complications. A foreign object also seen on computerized tomography chest eight months later but not on the one month later study. Around two months later, computerized tomography chest showed redemonstration of embolized inferior vena cava filter leg within a patent foramen ovale. The linear metallic density structure extending within a patent foramen ovale was again noted, likely embolized inferior vena cava filter fragment. Around one month later, echocardiographic findings revealed that the thin metallic object passes from the right atrium to the left atrium across the foramen ovale, with the patient's known migration of an inferior vena cava filter fragment. The object projects at least 2. 5 cm into the left atrium and the tip appears more echodense than the remainder of the structure. Therefore, the investigation is confirmed for perforation of inferior vena cava (ivc), filter limb detachment and retrieval difficulties. 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. (expiry date: 12/2016).
 
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. At some time post filter deployment, it was alleged that the filter struts detached and perforated. Reportedly the detached inferior vena cava filter fragment migrated. The device was removed percutaneously. It was further reported that the detached strut was not removed and retained in right atrium to the left atrium across the foramen ovale. 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 Key12135130
MDR Text Key260472483
Report Number2020394-2021-80548
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 07/08/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/08/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberDL900J
Device Catalogue NumberDL900J
Device Lot NumberGFXK3070
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/11/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/17/2013
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: 07/08/2021 Patient Sequence Number: 1
Treatment
ACYCLOVIR, ALBUTEROL, ALENDRONATE, AZITHROMYCIN; BUDESONIDE/FORMOTEROL, DICLOFENAC, DOCUSATE; DOXYCYCLINE, VIT C, FAMOTIDINE, FOLIC ACID; DULOXETINE, ERGOCALCIFEROL, GABAPENTIN; LEVOTHYROXINE, MONTELUKAST, NABUMETONE; METRONIDAZOLE, RUXOLITINIB, TIMOLOL; OMEPRAZOLE, OXYCODONE, POSACONAZOLE; POTASSIUM CHLORIDE, PRAVASTATIN, PREDNISONE; SENNA, TRIMETHOPRIM-SULFAMETHOXAZOLE; TOBRAMYCIN, LOVENOX, LORAZEPAM
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