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U.S. Department of Health and Human Services

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

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BARD PERIPHERAL VASCULAR, INC. G2 EXPRESS FILTER SYSTEM - FEMORAL VENA CAVA FILTER Back to Search Results
Catalog Number RF400F
Device Problems Malposition of Device (2616); Patient Device Interaction Problem (4001)
Patient Problem Pulmonary Embolism (1498)
Event Date 07/31/2016
Event Type  Injury  
Manufacturer Narrative
The 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 five years and eight months post filter deployment, computed tomography revealed pulmonary arterial vasculature well opacified with a tiny focal pulmonary embolism right lower lobe pulmonary arterial branch of unclear clinical significance and acuity. Approximately one year later, computed tomography revealed apex of the device at the level just below the lower right renal vein orifice. The alignment of the filter was not remarkable relative to the lumen of the long axis of the inferior vena cava. The apex of the filter was not appeared to be in contact with the wall of the inferior vena cava. The distal struts of the filter appear to extend beyond the inferior vena cava wall with fat plane in between. The distal aspect of one of the medial struts extends to and in contact with the right lateral aspect of the abdominal aorta. Therefore, the investigation is confirmed for perforation of the inferior vena cava (ivc). However, the investigation is inconclusive for filter tilt. Additionally, it can be confirmed that the patient experienced pulmonary embolism 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.
 
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 no thrombolytics due to recent surgery. At some time post filter deployment, it was alleged that the filter tilted and struts perforated the vena cava wall and aorta. 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.
 
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Brand NameG2 EXPRESS FILTER SYSTEM - FEMORAL
Type of DeviceVENA 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 Key11385339
MDR Text Key233774128
Report Number2020394-2021-80210
Device Sequence Number1
Product Code DTK
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K080668
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 02/26/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/26/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberRF400F
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/01/2021
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 Treatment Data
Date Received: 02/26/2021 Patient Sequence Number: 1
Treatment
EZETIMIBE, FOLIC ACID, LOSARTAN, METOPROLOL; PAROXETINE, WARFARIN, PRILOSEC, AND LISINOPRIL; TYLENOL, VITAMIN E, ZINC, SIMVASTATIN; XARELTO, ALBUTEROL, ASPIRIN, BENZONATATE
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