MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. G2X FILTER - FEMORAL; VENA CAVA FILTER

Catalog Number RF400F

Device Problems Malposition of Device (2616); Patient-Device Incompatibility (2682); Detachment of Device or Device Component (2907); Material Deformation (2976)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

Manufacturing review: this is the first complaint reported to date for this product and lot, therefore a device history record review is not required.Investigation summary: the device was not returned for evaluation.Images and medical records were provided and reviewed.Approximately, eleven months and four days of post deployment, a lower extremity venous duplex study was performed which showed patent inferior vena cava.The filter was visualized within the infrarenal inferior vena cava.Chronic occlusive deep vein thrombosis of the left proximal to mid main thigh femoral vein and chronic non-occlusive deep vein thrombosis of the left mid-distal main thigh femoral vein, popliteal vein and peroneal calf veins.Around, two months and twenty-seven days later, a lower extremity venous duplex study was performed which showed patent inferior vena cava.The filter was visualized within the mid infrarenal inferior vena cava.Around, eleven months and twenty-two days later, a lower extremity venous duplex study was performed which showed patent inferior vena cava.The filter was visualized within the mid infrarenal inferior vena cava.Around, one year and one month later, a lower extremity venous duplex study was performed which showed indirect evidence of patent inferior vena cava.Around one year and four days later, a lower extremity venous duplex study was performed which showed indirect evidence of patent inferior vena cava.Around, one year eight months later, an x-ray abdomen was performed which showed an inferior vena cava filter was noted to the right of midline at the l1-l2 level.A lower extremity venous duplex study was performed which showed indirect evidence of patent inferior vena cava.Patient presented for follow-up evaluation of venous disease.An x-ray of abdomen reveals one tine was dislodged or moved in a different direction and recommended for a follow-up x-ray in one year.Around, five months and fifteen days later, an x-ray abdomen was performed which showed a metallic vena cava filter was noted on the right side of midline at the l2 vertebral level with slight tilt.Around, twenty-eight days later, a computed tomography of abdomen was performed for filter evaluation.The study showed that well positioned inferior vena cava filter at 1.5 cm below the level of renal veins.Around, one years and eleven months later, a lower extremity venous duplex study was performed which showed patent vena cava.Bright echoes are visualized within the inferior vena cava, most likely represents a filter.Around, one year and eight months later, a computed tomography of abdomen was performed which showed an infrarenal inferior vena cava filter was noted in unchanged alignment.The distal margin of the tines extends beyond the periphery of the vessel, which was a common finding.One of the tines erodes into the superior l3 endplate associated bony remodeling.Around, one year five months later, computed tomography of abdomen was performed which revealed an inferior vena cava filter in place.The proximal aspect of the filter, its tip, was positioned 22 mm below the floor of the right renal vein.The tip of the filter was located at about 10.30 o'clock position along the walls of the inferior vena cava.The axis of the filter was oriented along the axis of the inferior vena cava, disc when viewed in the coronal plane.It was slightly tilted dorsally about ten degrees relative to the axis of the inferior vena cava, the shorter prongs of the filter were fully deployed and relatively equidistant and along the walls of the inferior vena cava.The longer prolongs, those medial and the medial posterior extent beyond the confines of the walls of the inferior vena cava.Specifically, the prongs that was at about the 5 o'clock position ends 8 mm outside the wall of the inferior vena cava.There was no fracture or displacement of the components of the filter.No luminal narrowing of the inferior vena cava about and outside the location of the filter.No fluid collection within the retroperitoneum in between the inferior vena cava or the aorta.Around, twenty days later, x-ray of abdomen was performed for broken inferior vena cava filter/strut missing which revealed an inferior vena cava filter was noted at l2-l3.On the same day, x-ray of chest was performed which showed thin metallic strut overlies the right middle lobe region.A computed tomography of chest, abdomen and pelvis without contrast was performed which showed inferior vena cava filter was in place inferior to the renal veins.The apex of the filter was noted at the anterior aspect of the inferior vena cava.The constraints of the inferior vena cava filter appear to extend through the caval wall.The most prominent extension was at a posterior stripe, extending to the anterior aspect of the l2-l3 disc level.A total of eleven metallic struts identified.No metallic density foreign bodies in the vasculature outside of the inferior vena cava filter identified.Therefore, the investigation is confirmed for perforation of the inferior vena cava(ivc), filter limb detachment and material deformation.However, the investigation is unconfirmed for filter tilt as the medical record states that the filter was slightly tilted dorsally about ten degrees relative to the axis of the inferior vena cava.Based upon the available information, the definitive root cause is unknown.Labeling review: the review of the ifu (instructions for use), indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.

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 tilted.The device has not been removed and there were no reported attempts made to retrieve the filter.The current status of the patient is unknown.

• Brand Name: G2X FILTER - FEMORAL
• 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: 12310485
• MDR Text Key: 266151113
• Report Number: 2020394-2021-80697
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2012
• Device Catalogue Number: RF400F
• Device Lot Number: GFTG2551
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/13/2021
• Initial Date FDA Received: 08/11/2021
• 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 Age: 66 YR
• Patient Weight: 91