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Catalog Number RF400J
Device Problems Partial Blockage (1065); Difficult to Remove (1528); Malposition of Device (2616); Material Deformation (2976); Patient Device Interaction Problem (4001)
Patient Problems Pulmonary Embolism (1498); Thrombosis/Thrombus (4440)
Event Date 02/28/2010
Event Type  Injury  
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. The medical records allege bard g2x filter was deployed at an unknown location, for a patient with deep vein thrombosis and in conjunction with gastric bypass. Approximately one month and three days of post deployment, a computed tomography angiography (cta) abdomen with and without intravenous contrast showed that an inferior vena cava filter was placed within the distal inferior vena cava at the level of the bifurcation with minimal clot superiorly, clot within the filter and extended down the right iliac vein. Additionally, there was evidence for filling defects within lower lobe pulmonary arteries, previously noted. On the same day, a computed tomography angiography (cta) pelvis demonstrated an inferior vena cava filter, which was appropriately positioned within the cava; however, there is thrombus which appeared to have propagated above the inferior vena cava filter to the renal veins and extended through the filter down through the lower abdominal cava and into the proximal common left innominate vein as well as throughout the entire right common and external iliac veins down to the femoral vein in the upper thigh. Also, an ultrasound doppler venous lower unilateral left demonstrated no evidence of deep vein thrombosis in the left lower extremity. An ultrasound doppler venous lower unilateral right showed occlusive thrombus that involved the entire visualized deep venous system of the right lower extremity. Around one day later, the patient presented with thrombus that involved the entire right lower extremity extended into the pelvis and up into the inferior vena cava where the patient had thrombosed filter. A contrast injection demonstrated thrombus extended up to and just above the inferior vena cava filter. On the same day, the patient underwent mechanical thrombectomy and placement of thrombolytic catheter. The next day, the patient¿s clinical indication stated that the filter was partially occluded with thrombosis into the right lower extremity. The patient¿s filter was surrounded by thrombus. There was some concern that the right iliac vein might have been compromised by the thrombus in the filter. The patient¿s filter was at the iliac vein bifurcation. The patient underwent mechanical thrombectomy and balloon angioplasty of the patient¿s inferior vena cava filter, left iliac vein and left common femoral vein. Around four months and five days later, an attempt was made to retrieve the filter from the patient¿s body. Percutaneous access of the jugular vein was performed with ultrasound guidance. Pigtail catheter was advanced down into the distal inferior vena cava and actually into the left iliac vein. Contrast injection demonstrated that the filter was seen with 1 leg of the filter in an abnormal position and the filter in a tilted position. The filter was attempted to be retrieved and multiple attempts were made using snares, as well as the retrievable device, without success. At this point, the catheter, guidewire and sheath were removed and pressure was held until hemostasis was confirmed. The filter was left in place and will be evaluated for removal at another time. One year and sixteen days later, an ultrasound doppler venous upper unilateral right showed evidence of non-occlusive thrombus within the right internal jugular vein. Also, a computed tomography angiography (cta) head showed thrombus formation in the proximal right internal jugular vein and distal right sigmoid sinus. Around eleven months and twenty-eight days later, a computed tomography angiography (cta) chest with and without intravenous contrast showed that there was a thin, linear filling defect within a right lower lobe pulmonary artery. This had the appearance of a chronic type filling defect rather than acute pulmonary embolus. There was a probable second filling defect in the sub segmental right lower lobe. Around five years and eleven months later, a computed tomography (ct) abdomen without intravenous contrast showed that the inferior vena cava filter tip was immediately below the l3 level, with the tip appeared to extend about 5 mm beyond the lateral margin of the inferior vena cava and struts extended down to the bottom of l4. The filter was tilted to the right and slightly posterior, with its tip appeared to protrude about 7 mm beyond the medial inferior vena cava wall and extended into the posterior bifurcation of the aorta, in broad contact with the posterior wall of the right common iliac vein takeoff. The lower tips of the right sided filter struts occurred just above the confluence of the right common iliac vein with 1 of the struts extended about 3 mm beyond the anterior wall. No fractured struts were identified. Therefore, the investigation is confirmed for perforation of inferior vena cava, filter tilt, material deformation, partial occlusion of inferior vena cava (ivc) and retrieval difficulties. Additionally, it can be confirmed that the patient experienced thrombus above filter and pe post deployment. However, the relationship to the filter is unknown. Per medical records, multiple attempts were made to engage the apex of the filter but were unsuccessful due to perforation of inferior vena cava, filter tilt, material deformation and occlusion of ivc filter. 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. (expiry date: 11/2012).
Event Description
It was reported through the litigation process that a vena cava filter was placed in a patient in conjunction with or before bariatric procedure. At some time post filter deployment, it was alleged that the filter tilted and embedded in wall of the inferior vena cava. The device has not been removed after an attempted but unsuccessful percutaneous removal procedure. The current status of the patient is unknown.
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Manufacturer (Section D)
1625 w 3rd st.
tempe AZ 85281
Manufacturer (Section G)
289 bay road
queensbury NY 12804
Manufacturer Contact
judith ludwig
1415 w. 3rd street
tempe, AZ 85281
MDR Report Key12126887
MDR Text Key260215640
Report Number2020394-2021-80538
Device Sequence Number1
Product Code DTK
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,health professional
Reporter Occupation
Type of Report Initial
Report Date 07/07/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/07/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberRF400J
Device Lot NumberGFTJ1684
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/10/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/06/2009
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 07/07/2021 Patient Sequence Number: 1