MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. G2 FILTER SYSTEM - FEMORAL; VENA CAVA FILTER

Catalog Number RF310F

Device Problems Malposition of Device (2616); Patient-Device Incompatibility (2682); Extrusion (2934)

Patient Problems Pulmonary Embolism (1498); Pain (1994); No Consequences Or Impact To Patient (2199); Thrombosis/Thrombus (4440)

Event Date 08/16/2010

Event Type  Injury  

Manufacturer Narrative

Manufacturing review: as the lot number for the device was not provided, a manufacturing review could not be performed.Investigation summary: the device was not returned for evaluation.Images and medical records were not provided for review.Therefore, the investigation is inconclusive for tilt and perforation as no objective evidence has been provided to confirm any alleged deficiency with the filter.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.The information provided by bard 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 bard.

Event Description

It was reported through the litigation process that some time post filter deployment, the patient allegedly experienced ivc perforation in which the struts project into the infrarenal abdominal aorta with tilting of the entire filter.There were no reported attempts made to retrieve the filter.The 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, nine months thirty days of post deployment, a left lower extremity venous doppler showed no deep venous thrombosis in the left leg.Around one year and eight months later, a venography demonstrated thrombus up to the level of inferior vena cava filter.Also, an ultrasound venous duplex extremity complete bilateral demonstrated positive for deep venous thrombosis, that involved the entire deep venous system of the right leg as well as left common femoral vein, profunda femoral vein and proximal superficial femoral vein of the left leg.On the next day, a venography showed extensive thrombosis of the pelvic venous system, that extended to the level of the filter.After, two days, a pelvic venography demonstrated that there was evidence of some thrombus still present within the filter.On completion of the mechanical thrombectomy, no residual thrombus in the filter was noted.Around, one year and eleven months later, the patient was diagnosed with pulmonary embolism.After, two months and twenty- three days, the patient presented with mild to lower back pain.On the same day, a computed tomography (ct) lumbar spine without contrast showed that there was an inferior vena cava filter in place, which was tilted with the superior aspect of the filter directed anteriorly.The legs of the filter projected well outside the level of the lumen of the inferior vena cava.There was a left leg of the inferior vena cava filter, that projected into the level of the infra renal abdominal aorta, and possible incorporation of the filter into the abdominal aorta was not excluded.Legs of the filter approached but did not appeared to actually contact the l3 vertebral body.Around, two years and two months later, an ultrasound lower extremity venous duplex left showed no evidence of deep venous thrombosis.Around, one year and three months, the patient presented with unspecified abdominal pain.On the same day, a computed tomography (ct) abdomen and pelvis without contrast showed that an inferior vena cava filter was noted and 1 of the struts extended to the right aorta, which was unchanged from computed tomography (ct) lumbar spine scan.After, one week and two days, a computed tomography (ct) abdomen and pelvis with intravenous and oral contrast demonstrated that just below the renal veins, there was an inferior vena cava filter.After, two months and twenty-nine days, a computed tomography (ct) abdomen with and without intravenous contrast showed that there was an inferior vena cava filter, as well as common iliac stent bilaterally.The struts of the inferior vena cava filter protruded outside the lumen of the inferior vena cava, with 1 strut penetrated to the into the aorta and the posterior struts extended to the lumbar spine.After, three months and four days, a computed tomography (ct) abdomen and pelvis with and without contrast showed that there was a filter in the infra renal inferior vena cava.Several of the struts extended beyond the inferior vena cava and 1 of these involved the aorta, which was unchanged.After, five months and twenty-eight days, a computed tomography (ct) abdomen and pelvis with and without contrast showed that the inferior vena cava was patent with a filter.After, one month and nine days, an attempt was made to retrieve the filter from the patient¿s body.Under ultrasound guidance, the right internal jugular vein was accessed using a micropuncture needle.An inferior venacavogram demonstrated patency of the iliac stent as well as the bard inferior vena cava filter.There was penetration by at least 6 of the visualized arms.There was no significant thrombus within the inferior vena cava filter.An amplatz wire was inserted and under fluoroscopic guidance and a 16 french 40 cm sheath was advanced to the top of the inferior vena cava filter.Given the previous computed tomography (ct) scan demonstrated the tip of the inferior vena cava filter within the wall of the inferior vena cava, attempts at using a loop snare were not performed as it would not be successful.Using an endobronchial forceps device through the 16 french sheath, careful dissection was performed along the superior margin of the filter, eventually freeing the proximal margin of the filter.Once this was performed, the proximal margin of the filter was grabbed by the endobronchial forceps and under gentle retraction the 16 french sheath was advanced over the endobronchial forceps removing the filter in its entirety.Final fluoroscopic image demonstrated no residual filter fragments present.A follow-up venogram demonstrated no evidence of active extravasation and no evidence of flow-limiting stenosis.Absorbable suture was applied to the dermatotomy and the patient tolerated the procedure well without immediate complication.Therefore, the investigation is confirmed for the perforation of the inferior vena cava(ivc) and filter tilt.Additionally, it can be confirmed that the patient experienced pe post deployment.However, the relationship to the filter is unknown.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.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 and for right hip replacement.At some time post filter deployment, the patient allegedly experienced inferior perforation in which the struts project into the infra renal abdominal aorta with tilting of the entire filter.The device was removed percutaneously.The current status of the patient is unknown.

• Brand Name: G2 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: 7644194
• MDR Text Key: 112557015
• Report Number: 2020394-2018-01005
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• PMA/PMN Number: K062887
• 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: 05/31/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: RF310F
• Device Lot Number: UNKNOWN
• 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: DITROPAN-XL, ZOCOR, COUMADIN AND CLARITIN; JANUVIA, MELATONIN, TOPROL-XL AND PRILOSEC; OMEPRAZOLE, OXYBUTYNIN, ZYRTEC AND LOVENOX; TRAMADOL
• Patient Outcome(s): Other
• Patient Age: 61 YR
• Patient Weight: 108