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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); Detachment of Device or Device Component (2907)
Patient Problem Chest Pain (1776)
Event Date 12/22/2014
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 three months three days post filter deployment, first attempt was made to retrieve the filter. Digital subtraction angiography (dsa) images of the inferior vena cava filter revealed the filter was tilted with its hook directly abutted the left wall of the inferior vena cava. Multiple attempts were made unsuccessfully to retrieve the filter using loop snare and ensnare devices. Approximately 2 months and 21 days later, second attempt was made to retrieve the filter. Multiple spot images of the filter revealed tip was embedded and the filter was intact. The filter was then dissected free of the wall of the inferior vena cava using endobronchial forceps in the jaws of life technique. It was removed successfully. Normal pulmonary arteriogram demonstrated exception of serpiginous somewhat radiopaque foreign body in a proximal left lower lobe pulmonary artery branch. During retrieval, the fragments became dissociated and 1 small fragment embolized more distally with 1 remained in the same location. Attempt was made to remove 2 additional fragments within the left lower lobe, but unsuccessful. Therefore, the investigation is confirmed for filter tilt, filter limb detachment and retrieval difficulties. However, the investigation is inconclusive for perforation of the inferior vena cava (ivc). Per medical records, multiple attempts were made to engage the apex of the filter using snare and forceps but were unsuccessful due to filter tilt and embedment. This could have contributed to the retrieval difficulties. However, the definitive root cause is unknown. Labeling review: instruction for use: precautions: the safety and effectiveness of this device has not been established for morbidly obese patients. Abdominal procedures such as bariatric surgery may affect the integrity and stability of the filter. 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. (b)(4).

 
Event Description

It was reported through the litigation process that a vena cava filter was placed in a patient in conjunction with or before bariatric procedure. At some time post filter deployment, filter tilted, struts detached and perforated into organs. It was further reported that the filter and three detached limbs were removed percutaneously; however two detached limbs remain in left lung. The device was removed percutaneously after two attempts attempted but unsuccessful removal procedure. The patient reportedly experienced chest pain; however; 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 Key10423944
MDR Text Key203446337
Report Number2020394-2020-05439
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 08/19/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/19/2020
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 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 Received07/23/2020
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: 08/19/2020 Patient Sequence Number: 1
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