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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. G2 FILTER SYSTEM - JUGULAR; VENA CAVA FILTER
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BARD PERIPHERAL VASCULAR, INC. G2 FILTER SYSTEM - JUGULAR; VENA CAVA FILTER Back to Search Results
Catalog Number RF320J
Device Problems Detachment of Device or Device Component (2907); Patient Device Interaction Problem (4001)
Patient Problems Pulmonary Embolism (1498); Thrombosis/Thrombus (4440)
Event Date 12/04/2009
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.Expiration date: 03/2012.
 
Event Description
It was reported through the litigation process that a vena cava filter was placed in a patient after being diagnosed with bilateral deep vein thrombosis and pulmonary embolism.Approximately seven months later post filter deployment, it was alleged that the filter struts perforated, detached and patient was diagnosed with thrombosis and pulmonary embolism.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.
 
Event Description
It was reported through the litigation process that a vena cava filter was placed in a patient after being diagnosed with bilateral deep vein thrombosis and pulmonary embolism.Approximately seven months later post filter deployment, it was alleged that the filter struts perforated, detached and patient was diagnosed with thrombosis and pulmonary embolism.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.
 
Manufacturer Narrative
H10: 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, seven months post filter deployment computed tomography of abdomen and pelvis with contrast was performed which revealed an inferior vena cava filter in place and findings suggest high probability for pulmonary embolism.After five days, computed tomography of positron emission tomography acquisition was performed which showed inferior vena cava filter was in place.Around, four years and fifteen days later, cardiac compression index (x-ray) of chest posteroanterior and lateral view was performed for venous thrombosis which revealed partially imaged inferior vena cava filter overlying the right lateral margin of the lumbar spine.Around, three years and two months later, computed tomography of abdomen and pelvis with contrast was performed for epigastric pain coughing up blood-tinged mucus which showed patient had an inferior vena cava filter, which was somewhat malpositioned with struts of the inferior vena cava filter extending beyond the margin of the inferior vena cava.One of these extend posterior to the aorta.The other extends into the right iliopsoas muscle.A couple of these appear to be fractured.The inferior vena cava at and below the filter was small with no opacification suggesting thrombosis.Around, one month and twenty-five days later, computed tomography of abdomen and pelvis with contrast was performed which showed again an infra renal inferior vena cava filter with struts extending beyond the wall of the inferior vena cava and with a diminutive appearance of the inferior vena cava with numerous retroperitoneal collateral vessels in the abdomen and pelvis anteriorly and in the right anterior thigh.Around, twenty-one days later, the patient experienced back pain, inferior vena cavogram was performed for fractured inferior vena cava filter which revealed initial scout images of filter with multiple fractured legs projected over the abdomen and projecting over the pelvis.Venogram revealed complete occlusion of inferior vena cava at the inferior most aspect of the filter, 2.1cm central from the iliac bifurcation.Therefore, the investigation is confirmed for the perforation of the inferior vena cava (ivc) and filter limb detachment.Additionally, it can be confirmed that the patient experienced 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.H10: d4(expiry date: 03/2012),g3,h6(method).H11: h6(result and conclusion).H11: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.
 
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Brand Name
G2 FILTER SYSTEM - JUGULAR
Type of Device
VENA CAVA FILTER
Manufacturer (Section D)
BARD PERIPHERAL VASCULAR, INC.
1625 w 3rd st.
tempe AZ 85281
MDR Report Key12187694
MDR Text Key262157977
Report Number2020394-2021-80578
Device Sequence Number1
Product Code DTK
Combination Product (y/n)N
PMA/PMN Number
K052578
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,health professional
Type of Report Initial,Followup
Report Date 08/03/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/19/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberRF320J
Device Lot NumberGFTB3660
Was Device Available for Evaluation? No
Date Manufacturer Received07/22/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
ALLOPURINOL, ROCEPHIN AND ZITHROMAX.; ALLOPURINOL, ROCEPHIN AND ZITHROMAX.; FUROSEMIDE, CIPROFLOXACIN, TRIAMTERENE HCTZ, COREG.; FUROSEMIDE, CIPROFLOXACIN, TRIAMTERENE HCTZ, COREG.; LASIX, LISINOPRIL, COUMADIN, LOVENOX.; LASIX, LISINOPRIL, COUMADIN, LOVENOX.; MEDROL DOSEPAK, ARIXTRA.; MEDROL DOSEPAK, ARIXTRA.; NIFEDIPINE, VICODIN, FOLIC ACID, FERROUS SULFATE.; NIFEDIPINE, VICODIN, FOLIC ACID, FERROUS SULFATE.; ALLOPURINOL, ROCEPHIN AND ZITHROMAX; FUROSEMIDE, CIPROFLOXACIN, TRIAMTERENE HCTZ, COREG; LASIX, LISINOPRIL, COUMADIN, LOVENOX; MEDROL DOSEPAK, ARIXTRA; NIFEDIPINE, VICODIN, FOLIC ACID, FERROUS SULFATE
Patient Outcome(s) Life Threatening; Other;
Patient Age37 YR
Patient Weight108
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