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U.S. Department of Health and Human Services

Medsun Reports
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Type of Device:
FILTER, INTRAVASCULAR, CARDIOVASCULAR
Device Brand Name:
Bard G2X
Device Manufacturer's Name:
BARD PERIPHERAL VASCULAR, INC.
Date of this Report:
(mm/dd/yyyy)
03/01/2016
Describe the Event
or Problem:
Approximately 6 years ago, an outside hospital implanted a Bard G2X IVC filter. On two different dates last year, outside hospital images showed migration of the IVC filter from the infrarenal IVC to the anterior IVC atrial junction within the eustachian valve. The filter apex was found to be severely tilted and embedded along the wall. There was multifocal penetration of filter components along the hepatic vein confluence. There were at least 3 fractured filter arms with prior embolization into the pulmonary artery branches (2 in the RLL, 1 in the LLL). Approximately 5 months ago, the patient underwent complex IVC filter removal since it was agreed that the IVC filter was no longer required given full recovery from acute VTE and no recurrence with therapeutic anticoagulations. Using routine techniques and minimal manipulation, 2 additional fractured filter arms were identified. During routine extraction of the main filter body, 1 filter arm embolized into the right ventricle. This fragment subsequently traveled from the right ventricle to the pulmonary artery.
the device(s) may have
caused or contributed to:
Potential for patient harm
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