Model Number ASD37A |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Thrombosis/Thrombus (4440)
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Event Date 12/28/2021 |
Event Type
Injury
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Manufacturer Narrative
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The gore® cardioform asd occluder instructions for use states: adverse events associated with the use of the occluder may include but are not limited to: thrombosis or thromboembolic event resulting in clinical sequelae.
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Event Description
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It was reported to gore a 37mm gore® cardioform asd occluder was implanted on (b)(6) 2021 to treat an atrial septal defect.Echocardiogram on (b)(6) 2021 showed a small thrombus on the device.The patient was treated with xarelto.Follow-up echocardiogram on (b)(6) 2022 showed the thrombus present and slightly larger in size.The patient is to start on coumadin on (b)(6) 2022.
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Event Description
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It was reported to gore a 37mm gore® cardioform asd occluder was implanted on (b)(6) 2021 to treat an atrial septal defect.Echocardiogram on (b)(6) 2021 showed a small thrombus on the device.The patient was treated with xarelto.Follow-up echocardiogram on (b)(6) 2022 showed the thrombus present and slightly larger in size.The patient is to start on coumadin on (b)(6) 2022.
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Manufacturer Narrative
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The gore® cardioform asd occluder instructions for use states: adverse events associated with the use of the occluder may include but are not limited to: thrombosis or thromboembolic event resulting in clinical sequelae.In the echo imaging provided, it appears that the device is in a stable and satisfactory position but this cannot be confirmed without fluoro imaging.The left atrial disc appears flat and well apposed to the atrial septum.The right atrial disc is also flat and well apposed to the atrial septum.The appearance of the vegetative growth on the right atrial disc is consistent with a thrombus formation.The growth is protruding into the right atrium but does not appear larger in the echo images 1 month apart.From the imaging provided, the cause of the vegetative growth cannot be determined.
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Search Alerts/Recalls
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