W. L. GORE & ASSOCIATES, INC. GORE® CARDIOFORM ASD OCCLUDER; TRANSCATHETER, SEPTAL OCCLUDER
|
Back to Search Results |
|
Catalog Number ASD37E |
Device Problems
Inadequacy of Device Shape and/or Size (1583); Adverse Event Without Identified Device or Use Problem (2993); Migration (4003)
|
Patient Problems
Obstruction/Occlusion (2422); Foreign Body Embolism (4439)
|
Event Date 03/23/2022 |
Event Type
Injury
|
Event Description
|
It was reported to gore that on (b)(6) 2022, a 37mm gore® cardioform asd occluder was selected to treat an atrial septal defect measuring 15mm on balloon sizing, questionable residual flow on trans-oesophageal echocardiogram (toe), but waist on fluoroscopy.On initial deployment the device looked very flat.The device was redeployed and initially looked good but then it was seen on toe that it had come through into the right atrium.The device was taken out and flushed.There was discussion regarding reattempting with this device and it was felt that one last attempt would be made.The device redeployed and locked, however, when the device was locked it rotated, but appeared to be in a good position on toe, and although multiple fluoroscopy angles taken to see separation it was difficult.The physician was happy to release the device.When the device was fully released there was a very small inferior residual leak.The device was left in place.The patient was scanned around lunch time and the device was still in place.The patient had an echocardiogram the next morning and the device was there.A chest x-ray was done prior to patient the being discharged and the device was noted to be in the left pulmonary artery.The patient was offered trans-catheter removal or surgical removal.It was reported the device was successfully removed surgically on (b)(6) 2022.The patient was extubated and sitting out of bed on (b)(6) 2022.Further update was provided that the patient was discharged to home and is doing well.
|
|
Manufacturer Narrative
|
H10/11: a request for additional information as to the cause of the device embolizing was made, however, no further information was reported to gore.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: device embolization h6: health effect - clinical code changed to 4439.Medical device problem code - removed 2993 and added 4003, 1583.Type of investigations codes - 4114 changed to 4117, added 4111.Investigation findings code 3233 updated to 213, 3207.Investigation conclusions codes updated code 11 to 4315, 22.
|
|
Search Alerts/Recalls
|
|
|