The following information was reported to gore: on (b)(6) 2018 a patient was undergoing treatment of a splenic artery aneurysm with a gore® viabahn® endoprosthesis.The device was advanced over a.018" v18 wire through a 6fr terumo sheath, to the desired location.Deployment was initiated, however about halfway through deployment, the deployment line broke, leaving half of the device remaining constrained on the delivery catheter.The device was then pulled back through the brachial access.The case was finished by using coils to embolize the aneurysm.The case was completed with another device.The patient tolerated the procedure.
|
Should have been blank in the initial medwatch.Results code 2 updated: 213: the engineering evaluation stated the following: the following observations were made: the deployment knob, deployment line, endoprosthesis, and portion of the delivery catheter were not returned.The distal tip and distal shaft, upon which the endoprosthesis was mounted, were not returned.The dual lumen appeared to be cut at 115 cm past the hub (see c18-659 dual lumen cut 1.Jpg and c18-659 dual lumen cut 2.Jpg).The remainder of the dual lumen/transition were not returned.There were catheter kinks at 15, 31, 81, 87, and 96 cm from hub.Based on the device examination performed, no manufacturing anomalies were identified.
|