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

Catalog Number EC500J

Device Problems Patient-Device Incompatibility (2682); Detachment of Device or Device Component (2907); Unintended Movement (3026); Patient Device Interaction Problem (4001)

Patient Problems Hemorrhage/Bleeding (1888); Blood Loss (2597)

Event Date 11/19/2012

Event Type  Injury  

Manufacturer Narrative

As the lot number for the device was provided, a review of the device history records is currently being performed.The device has not been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.(expiry date: 05/2015).

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 perforated into organs.The device was removed percutaneously.The current status of the patient is unknown.

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 perforated into organs.It was further reported that the ivc filter dislodged and caused bleeding.The device was removed percutaneously.The current status of the patient is unknown.

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.Images were not provided.Medical records were provided and reviewed.Approximately one month post filter deployment, patient had stent placement due to kidney stone.Subsequently a few days later, it was found that the filter was dislodged and it caused bleeding.The old filter was successfully removed.Therefore, the investigation is confirmed for unintended movement of the filter.However, the investigation is inconclusive for perforation of the ivc.Based upon the available information, the definitive root cause is unknown.Labeling review: the current instructions for use states: warnings: movement, migration, fractures or tilt of the filter are known complications of vena cava filters.Potential complications: complications may occur at any time during or after the procedure.Possible complications include, but are not limited to: migration of filters to the heart or lungs has been reported.There have also been reports of caudal migration of the filter.Migration may be caused by placement in ivcs with diameters.Exceeding the appropriate labeled dimensions specified in this ifu.Migration may also be caused by improper deployment, deployment into clots and/or dislodgement due to large clot burdens.Filter fractures are a known complication of vena cava filters.There have been some reports of serious pulmonary and cardiac complications with vena cava filters requiring the retrieval of the fragment utilizing endovascular and/or surgical techniques.Detachment of components.Perforation or other acute or chronic damage of the ivc wall.Acute or recurrent pulmonary embolism.This has been reported despite filter usage.It is not known if thrombi passed through the filter, or originated from superior or collateral vessels.Deep vein thrombosis.Caval thrombosis/occlusion.Extravasation of contrast material at time of venacavogram.Air embolism.Hematoma or nerve injury at the puncture site or subsequent retrieval site.Hemorrhage.Restriction of blood flow.Occlusion of small vessels.Distal embolization.Infection.Intimal tear.Stenosis at implant site.Failure of filter expansion/ incomplete expansion.Insertion site thrombosis.Filter malposition.Vessel injury.Arteriovenous fistula.Back or abdominal pain.Filter tilt.Hemothorax.Organ injury.Phlegmasia cerulea dolens.Pneumothorax.Postphlebitic syndrome.Stroke.Thrombophlebitis.Venous ulceration.Blood loss.Guidewire entrapment.Pain.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: 05/2015).

Manufacturer Narrative

H10: 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.Approximately two weeks later, the patient presented with lower abdominal pain.On the same day, a computed tomography (ct) abdomen and pelvis without contrast showed that there was an inferior vena cava filter in place.After one week, the patient was examined and found that the inferior vena cava filter dislodged and caused bleed.An attempt was made to retrieve the filter from the patient, who was diagnosed with migrated leg of the filter.Under direct ultrasound visualization, the right internal jugular vein was punctured with a micropuncture needle.Through a 10-french sheath, a snare was used to grasp the cephalad hook of the clips filter.The filter was captured into the sheath.The entire filter was withdrawn through the sheath.No extravasation was seen through the migrated stripe region on the inferior vena cava, during the contrast injection.Therefore, the investigation is confirmed for alleged filter limb detachment and unintended movement.However, the investigation is inconclusive for alleged perforation of the inferior vena cava.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.H10: b5,b6,b7,d10,d4(expiry date: 05/2015),g3.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 deep vein thrombosis/pulmonary embolism.At some time post filter deployment, it was alleged that the filter struts perforated into organs.It was further reported that the inferior vena cava filter dislodged and caused bleeding.The device was removed percutaneously.The current status of the patient is unknown.

• Brand Name: ECLIPSE FILTER SYSTEM - JUGULAR
• Type of Device: VENA CAVA FILTER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 8675911
• MDR Text Key: 147236637
• Report Number: 2020394-2019-00861
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• PMA/PMN Number: K093659
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: EC500J
• Device Lot Number: GFWD3709
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DILTIAZEM, DIGOXIN, VENTOLIN AND GLIPIZIDE; HEPARIN, LOVENOX, COUMADIN; HEPARIN, LOVENOX, COUMADIN; HEPARIN, LOVENOX, COUMADIN; METOPROLOL, LYRICA, LISINOPRIL AND LASIX; HEPARIN, LOVENOX, COUMADIN
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 66 YR
• Patient Weight: 106