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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); Malposition of Device (2616); Material Deformation (2976)
Patient Problems Extravasation (1842); Hematoma (1884); Blood Loss (2597)
Event Date 11/28/2017
Event Type  Injury  
Manufacturer Narrative

Manufacturing review: a lot history review was performed. This is the only complaint to date for this lot number. Therefore, a device history record review is not required. Investigation summary: the device was not returned for evaluation. Medical records were provided and reviewed. Approximately three months later, the patient underwent attempted inferior vena cava filter retrieval through right internal jugular vein access, but this was unsuccessful. Standard 12 french vascular sheath placed into the inferior vena cava and cavogram demonstrated no caval thrombosis. The filter had a new left-sided tilt. Prior inferior vena cavogram post placement demonstrated a normally aligned filter. A loop snare in sizes 2. 0 and 3. 0 cm was used to remove the filter and was unsuccessful. An additional en snare device was used which was also unsuccessful. The sheath was up sized to a 16 french sheath and grasping forceps were used to dislodge the filter which was also unsuccessful. A reverse curve catheter was used to realign the filter which was unsuccessful. Completion cavogram demonstrated some extravasation along the right caval wall. 1 of the filter limbs was inverted post retrieval attempts but not fractured. Fluoroscopic x-rays images showed an infrarenal bard denali filter with apex along the anterior wall. At least one filter leg was severely deformed from prior manipulation. The inferior vena cava filter struts remain attached to the apex of the filter. The apex of the filter on sagittal view was projecting outside of the anterior caval wall. There was some extravasation along the right with contrast from caval injection extravasation with mild pericaval hemorrhage. Right pericaval contrast and hematoma following attempted retrieval. After three months, patient diagnosed with embedded bard denali filter and had prior retrieval attempts which were unsuccessful and resulted in bending of one of the legs. The patient presented again for complex inferior vena cava (ivc) filter retrieval. Access was gained via right internal jugular vein. The sheath was advanced above the level of the filter and the rigid forceps were used to free the embedded hook of the filter from the inferior vena cava wall. Once the apex was within the sheath the 12-20 mm x 120cm en snare was used to engage the hook of the filter. The sheath was advanced until meeting a point of resistance along the caudal filter legs. Despite 6 lbs of force, the distal legs could not be captured. A 14fr glide light laser sheath was calibrated per protocol and advanced into the sheath until meeting the same point of resistance. With laser activation the filter was successfully captured into the sheath using 3 lbs. The filter was removed and examined. Therefore, the investigation is confirmed for alleged filter tilt, perforation of the inferior vena cava, material deformation, 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: 07/2020), (b)(4).

 
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 tilted and struts perforated into the organs. The device was removed after an unsuccessful percutaneous removal procedure. 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 Key11075197
MDR Text Key223705656
Report Number2020394-2020-06507
Device Sequence Number1
Product Code DTK
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK130366
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 12/28/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/28/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberDL900J
Device Catalogue NumberDL900J
Device LOT NumberGFBT3298
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/01/2020
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: 12/28/2020 Patient Sequence Number: 1
Treatment
LISINOPRIL, PAROXETINE, PAXIL, MIRALAX, .; RIVAROXABAN; XARELTO, COUMADIN, CLONAZEPAM, LEVOTHYROXINE
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