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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 Difficult to Remove (1528); Obstruction of Flow (2423); Malposition of Device (2616); Patient-Device Incompatibility (2682)
Patient Problems Pulmonary Embolism (1498); Thrombosis/Thrombus (4440)
Event Date 03/18/2021
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 after being diagnosed with deep vein thrombosis/pulmonary embolism.At some time post filter deployment, it was alleged that filter struts perforated into organs.The device has not been removed after an attempted but unsuccessful percutaneous removal procedure.The current status of the patient is unknown.
 
Manufacturer Narrative
Manufacturing review: a manufacturing review was not requested as the lot number reported as unknown.Investigation summary: the device was not returned for evaluation.Medical records were provided and reviewed.Approximately, seven years three months of post deployment, gunther tulip filter was placed above the old filter.There was massive clot throughout the venous structures with extension into the superior vena cava.Large clot extends through the previously placed filter and also to an area of approximately 3 cm cephalad to the filter.After, twenty days, the patient presented for filter removal, under real time ultrasound guidance with recording, a micro-puncture set was used to access the right internal jugular vein.5-french vascular sheath was placed, and a 5-french vert catheter was then advanced into the inferior vena cava.Venography demonstrates occlusive thrombus present within the lower inferior vena cava below the renal veins.The bilateral renal veins are patent.Both filters are imbedded within the thrombus.Occlusive thrombus present within the distal inferior vena cava with filter was in bed within it.Unable to remove the upper filter because of the thrombus.Around, three years and nine months later, computed tomography of the abdomen without contrast revealed 2 adjacent filters were present, the more caudad filter was immediately adjacent, with slight rightward tilt of apex abutted the right anterior inferior vena cava wall.No strut fracture.Multiple struts extend through the lumen, the greatest extend was approximately 1 cm to the left and projected over right side of aorta.Therefore the investigation is confirmed for the perforation of the inferior vena cava (ivc), filter tilt, retrieval difficulties and occlusion of the inferior vena cava (ivc).Additionally, it can be confirmed that the patient experienced pulmonary embolism and thrombus above the filter post deployment.However, the relationship to the filter is unknown.The definitive root cause could not be determined based upon available information.Labeling review: the review of the instructions for use, indications, warnings, precautions, cautions, possible complications, and contraindications 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.At some time post filter deployment, it was alleged that filter struts perforated into organs.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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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 Key11654945
MDR Text Key245076237
Report Number2020394-2021-00850
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 05/24/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/13/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberRF320J
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Date Manufacturer Received05/24/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Life Threatening; Other;
Patient Age48 YR
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