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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 Migration or Expulsion of Device (1395); Difficult to Remove (1528); Malposition of Device (2616)
Patient Problems Hematoma (1884); Cardiac Tamponade (2226); Cardiac Perforation (2513)
Event Date 11/01/2019
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 one year post filter deployment, the filter explant was scheduled through the right internal jugular vein. Inferior vena cavagram revealed the severe filter tilt to the right. The angled guidewire and sos omni catheter were sent down and was able to snare the filter using the gooseneck snare. This straightened out the filter, but it migrated to the right atrium. It was unable to snare it again to straighten it and it continued to move laterally. Repeated maneuvers were made to erect the filter for easy retrieval but without success. Soon, after this, the patient became hemodynamically unstable with a venogram that demonstrated suspected pericardial tamponade. An emergency pericardial window was created through which one liter of blood was removed. The vascular surgeon placed his finger into the heart and applied pressure to control the bleeding. The patient was transported to another hospital where an open heart surgery was done to remove the filter and repair the atrial perforation. A midline sternotomy was performed. Cursory exploration of the mediastinum demonstrated the tines of the filter protruding through the lateral wall of the right atrium. Additionally, there was a large hematoma between the right atrium and proximal ascending aorta. The caval snares were tightened and right atriotomy was performed. With the heart beating, the inferior vena cava filter was identified and carefully removed. The tip of the filter was in the vicinity of this hematoma. The area was examined and there was a large hole measuring 1. 5 cm in width identified. This was repaired using pledgeted 4-0 sutures. Small punctate perforations from the tines on the lateral wall of the right atrium were closed by 4-0 prolene sutures. Once satisfactory hemostasis was obtained, the sternum was re-approximated with stainless steel wires. The soft tissues was irrigated and closed in multiple layers using an absorbable suture. Therefore, the investigation is confirmed for filter tilt, filter migration and retrieval difficulties. Per medical records, multiple attempts were made to engage the apex of the filter using snare but were unsuccessful due to filter tilt. This could have contributed to the retrieval difficulties. However, 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. Device expiry date: 08/2021, (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 pulmonary embolism. At some time post filter deployment, it was alleged that the filter tilted, migrated. The device was removed via an open surgical procedure after an unsuccessful percutaneous removal procedure. It was reported that the filter perforated the right atrium, there was pericardial tamponade, bleeding and hematoma. 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 Key10122906
MDR Text Key194123930
Report Number2020394-2020-03654
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 OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial
Report Date 06/05/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/05/2020
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 NumberGFCU1154
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/11/2020
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: 06/05/2020 Patient Sequence Number: 1
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