MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. DENALI JUGULAR SYSTEM; VENA CAVA FILTER

Model Number DL900J

Device Problems Migration or Expulsion of Device (1395); Difficult to Remove (1528); Malposition of Device (2616)

Patient Problems Hematoma (1884); Hemorrhage/Bleeding (1888); 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.

Manufacturer Narrative

H10: 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, four months of post deployment, through the right internal jugular vein approach, the bard denali inferior vena cava filter was attempted for removal.The right internal jugular vein was accessed with an inferior vena cava retrieval sheath.An inferior vena cavogram was performed which demonstrated widely patent vena cava without thrombus in the filter and the filter was tilted to the right severely.Then a goose neck snare was used to snare the inferior vena cava filter, and this straightened out the intra vena cava filter which made the filter to migrate to the right atrium.The filter was able to be snared again in order to straighten it out on several locations, but it continued to move laterally.Multiple maneuvers were repeated to make the filter erect for easy retrieval without success.Then, through a 11 french sheath in the neck, a bronchial gasper was used and was gently tugged on to the filter without success and soon after this the patient¿s hemodynamics were unstable with a venogram that demonstrated a suspected pericardial tamponade.The patient received 5,000 units of heparin when the inferior vena cava filter was in the right atrium.A general surgery was then called to create an emergency pericardial window into the heart.It was found that the pericardial tamponade was likely due to the right atrial injury.During pericardial window it was found that the patient had a hemopericardium which might probably be due to some sort of either caval or atrial injury.There was no obvious sign that the filter had came up through the wall of the atrium, but it was not fully checked all the way to the right lateral side of the pericardium.There was a concern that on keeping the pericardial window open would cause the tamponade again and on the other hand draining the tamponade would lead to exsanguination.Due to both the concerns, it was decided to perform a sternotomy.A midline sternotomy was performed, and the pericardium was entered.Cursory exploration of the mediastinum demonstrated that the tine of the inferior vena cava filter was protruding through the lateral wall of the right atrium and there was a large hematoma between the right atrium and proximal ascending aorta.Cannulation sutures were placed in the ascending aorta and the right atrium.A 20 french arterial cannula was placed, and a right-angled tip 24 french cannula was placed into the superior vena cava directly followed by a 28 french single stage cannula into the inferior vena cava.Once a satisfactory activated clotting time was obtained, the patient was started on cardiopulmonary bypass.The caval snares were tightened and a right atriotomy was performed.With the heart beating, the inferior vena cava filter was identified and carefully extracted.It was found that the tip of the vena cava filter was in the vicinity of the large hematoma seen between the right atrium and aorta.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 and filter migration.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.The instructions for use states: precautions: if misplacement, sub-optimal placement, or tilting of the filter occurs, consider immediate removal.Do not attempt to reposition the filter.H10: b6, d4 (expiry date:08/2021), g3, h6 (method, conclusion).H11: h6 (result).H11:section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.

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.

• Brand Name: DENALI JUGULAR SYSTEM
• Type of Device: VENA 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 Key: 10122906
• MDR Text Key: 194123930
• Report Number: 2020394-2020-03654
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 00801741040795
• UDI-Public: (01)00801741040795
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130366
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DL900J
• Device Catalogue Number: DL900J
• Device Lot Number: GFCU1154
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/11/2020
• Initial Date FDA Received: 06/05/2020
• Supplement Dates Manufacturer Received: 11/24/2021
• Supplement Dates FDA Received: 12/03/2021
• 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 Sequence Number: 1
• Patient Outcome(s): Required Intervention; Other
• Patient Age: 66 YR
• Patient Sex: Female