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

Catalog Number UNK DENALI

Device Problems Difficult to Remove (1528); Detachment of Device or Device Component (2907); Material Deformation (2976)

Patient Problems Pulmonary Embolism (1498); Chest Pain (1776); Thrombosis/Thrombus (4440)

Event Date 09/02/2018

Event Type  Injury  

Manufacturer Narrative

As the lot number for the device was not provided, a review of the device history records could not be 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, the reason for deployment was not provided.At some time post filter deployment, it was alleged that the filter detached, the struts deformed and the patient reportedly experienced chest pain and was diagnosed with thrombus at the level of filter and pulmonary embolism.The device has been removed successfully after several unsuccessful retrieval attempts.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, the reason for deployment was not provided.At some time post filter deployment, it was alleged that the filter detached, the struts deformed and the patient reportedly experienced chest pain and was diagnosed with thrombus at the level of filter and pulmonary embolism.The device has been removed successfully after several unsuccessful retrieval attempts.The current status of the patient is unknown.

Manufacturer Narrative

Manufacturing review: a 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 one year and six months later, the patient reportedly experienced abdominal pain.A computed tomography chest abdomen pelvis wo contrast was performed on the same day which showed the inferior vena cava filter was in place.After one year and two months, the patient presented with chest pain.A nuclear medicine- ventilation perfusion scan showed that there was technically intermediate possibility for pulmonary embolism with moderate ventilation perfusion mismatch in the left upper lobe region.After two days, thrombolysis was scheduled.A venogram showed globular filling defects seen along the inferior vena cava extending at the level of filter.2 heavy legs were heading cephalad and one within the renal vein.Scout films of the abdomen showed the inferior vena cava filter in place with a liberated tine approximately 5cm cranial to the majority of the filter and multiple tines of the filter were deformed.After two months, filter removal was scheduled.Access was gained via the right internal jugular vein.A wire was advanced through the filter into the distal cava.Venogram showed that some of the legs were penetrating the left wall of the inferior vena cava.The hook appeared not to be free and possibly embedded.There was one of the leg deflected superiorly and it was not clear if it was attached to the filter.There was a slump of one of the arms consistent with a broken arm.Multiple attempts were made to engage the hook using gooseneck snare but that was unsuccessful.Subsequently, a tip deflecting wire was used to pull away from the cava but that was also unsuccessful.At this point, it was decided to go for a loop technique.The 14 french laser sheath was removed and and an sos catheter was placed around the neck of the filter and the glidewire was snared back through the 16 french sheath.The catheter was removed.At this point there was an exchange length glide wire around the neck of the filter back through the 16 french sheath and the physician folded the filter in half and removed it.The filter was inspected and had 6 legs but only 4 arms.It had 2 arms missing.Under fluoroscopic examination it was tried to identify it in the duodenum but it was not seen.With magnification fluoroscopy there was a fragment seen in the left chest.It wasn't clear if its in the heart or in the left lung.Steep oblique projections were performed and it seemed that the fragmented arm was in the lung and amount in the heart.It was decided to confirm this with computed tomography scan.On the same day, a computed tomography chest wo contrast was performed.Patient had a filter placed and one of the limbs was broken.Examination of the lungs demonstrated a linear metallic fragment in the base of the left lung which was consistent with a fractured limb.A second metallic fragment was seen in the proximal intrahepatic inferior vena cava adjacent to the vascular sheath tip.The fragmented arm of the filter in the intrahepatic cava was successfully snared and retrieved out of the body.Therefore, the investigation is confirmed for the alleged filter limb detachment, material deformation and retrieval difficulties.Additionally, it can be confirmed that the patient experienced thrombus above the filter and pulmonary embolism 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.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: DENALI FILTER SYSTEM
• Type of Device: VENA CAVA FILTER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 11840753
• MDR Text Key: 251143752
• Report Number: 2020394-2021-80446
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• PMA/PMN Number: K130366
• 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: 06/04/2021

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 Catalogue Number: UNK DENALI
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/21/2021
• Initial Date FDA Received: 05/18/2021
• Supplement Dates Manufacturer Received: 06/03/2021
• Supplement Dates FDA Received: 06/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: XARELTO; XARELTO; XARELTO
• Patient Outcome(s): Life Threatening; Other
• Patient Age: 57 YR
• Patient Weight: 132