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

Catalog Number EC500F

Device Problems Difficult to Remove (1528); Obstruction of Flow (2423)

Patient Problems Pulmonary Embolism (1498); Thrombosis/Thrombus (4440)

Event Date 09/24/2018

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.

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.The device was removed percutaneously.The patient reportedly diagnosed with post implant pulmonary embolism, however; 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.The device was removed percutaneously.The patient was diagnosed with pulmonary embolism post implant; however, 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.Medical records were provided and reviewed.Approximately, six years one month of post deployment, an ultrasound venous duplex lower extremity bilateral showed extensive left lower extremity deep vein thrombosis.Thrombus in left iliac vein appeared occlusive.On the next day, a computed tomography (ct) chest with contrast showed pulmonary emboli within the lobar and segmental pulmonary arterial vessels to the left upper lobe.After, two days, an inferior venacavagram showed extensive, occlusive deep vein thrombosis that extended from the left common femoral vein through suprarenal inferior vena cava.Thrombus extended to and above the level of a previously placed inferior vena cava filter.Also, a left lower extremity venogram showed extensive, occlusive deep vein thrombosis that extended from the left common femoral vein through suprarenal inferior vena cava.Thrombus extended to and above the level of a previously placed inferior vena cava filter.On the same day, the patient underwent mechanical thrombectomy.A follow-up venogram demonstrated there was a small amount of mural thrombus along the caval wall, that extended into the inferior vena cava filter, which was not occlusive.Around, one month and nineteen days later, a venous duplex iliac bilateral complete showed occlusive thrombus in the mid to distal inferior vena cava, extended into the left common iliac and left external iliac veins.Occlusive thrombus was seen in the left proximal common femoral vein and near occlusive thrombus in the mid left common femoral vein.Occlusive thrombus in the remnant proximal greater saphenous vein at the level of the saphenofemoral junction was noted.On the next day, an inferior venacavagram showed occlusion of inferior vena cava at the site of the filter and peripheral to it.On the next day, the patient presented with recurrent left lower extremity deep vein thrombosis, indwelling inferior vena cava filter with chronic thrombosis of the cava below the filter, as well as bilateral iliac veins.On the same day, an attempt was made to retrieve the filter from the patient¿s body.Left lower extremity venogram demonstrated some recanalization of the left external and common femoral veins; however, there was no definite flow through the inferior vena cava filter into the inferior vena cava.Attention was next turned towards removal of the filter, as this was felt to be the contributory cause for the patient¿s venous occlusion and recurrent deep vein thrombosis on coagulation.Through the internal jugular access, a bentson wire was exchanged over for a 16 french sheath, placed in the inferior vena cava above the level of the filter.Using a 15 mm gooseneck snare, attempts were made to snare the hook of the filter which were unsuccessful.Using an exchange length stiff glidewire and an omni flush catheter, the stiff glidewire was looped around the body of the filter.The free end of the wire was subsequently snared with the gooseneck snare and pulled through the sheath.Subsequently, with back tension on the wires while advancing the sheath, the inferior vena cava filter was collapsed and subsequently removed through the sheath.Follow-up venogram demonstrated patency of the cava from the level of the superior aspect of the filter, at approximately inferior margin of l3, with mild narrowing of the cava just below level of the renal vein inflow at approximately l2, but without thrombus.Therefore, the investigation is confirmed for the retrieval difficulties and occlusion of the inferior vena cava (ivc) filter.Additionally, it can be confirmed that the patient experienced thrombus above the filter post deployment and pe post deployment.However, the relationship to the filter is unknown.Based on 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: 04/2015.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.

• Brand Name: ECLIPSE FILTER SYSTEM - FEMORAL
• Type of Device: VENA CAVA FILTER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 11683858
• MDR Text Key: 245984901
• Report Number: 2020394-2021-80312
• 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
• Report Date: 05/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: EC500F
• Device Lot Number: GFWD0768
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: XARELTO, XANAX, ELIQUIS AND PERCOCET; XARELTO, XANAX, ELIQUIS AND PERCOCET; ZOLOFT, IMITREX, CIPRO AND COUMADIN; ZOLOFT, IMITREX, CIPRO AND COUMADIN; XARELTO, XANAX, ELIQUIS AND PERCOCET; ZOLOFT, IMITREX, CIPRO AND COUMADIN
• Patient Outcome(s): Life Threatening; Other
• Patient Age: 59 YR
• Patient Weight: 89