The following was reported to gore: during a difficult t-branch procedure with a cook device, access was gained from below to the visceral branches using an agilis catheter.A 12fr gore® dryseal flex introducer sheath (dryseal sheath) was placed and the agilis catheter was placed inside the dryseal sheath.The physician initially tried to deliver gore® viabahn® vbx balloon expandable endoprosthesis (vbx stent) to celiac artery (ca) branch, but that was not successful.The vbx stent was removed about four times.Three agilis catheters were used in total, so fresh valve was used for multiple re-entry attempts.The physician then tried to advance the vbx stent into the left renal artery (lra) branch.The last portion of the vbx stent was difficult to track through the tight junction.When the vbx stent was introduced about 80% into the lra the stent dislodged completely from the catheter.The physician then attempted to snare the vbx stent protruding from the side branch with an en-snare.However, this displaced the vbx stent from the side branch and the vbx stent continued to move toward the left subclavian arteries (lsca) within the cook device with each snaring attempt.Consequently, the constrained vbx stent was confined with a gore® tag® conformable thoracic stent graft with active control system (ctag).As reported, only 1 of 4 visceral branches was stented as the patient's anatomy was particularly challenging for a t-branch case.The patient tolerated the procedure and was reportedly to be stable.
|
Cbas® heparin surface incorporates carmeda heparin manufactured from heparin sodium api, which is covalently bound to the device surface and is essentially non-eluting.H6 - code c21 - review of device manufacturing record history is current underway.H6 - code b20 - dislodged vbx device was pinned to patient's vessel with another gore device.Therefore, direct product analysis was not possible.No images were provided by user facility.Ifu for gore® viabahn® vbx balloon expandable endoprosthesis warnings section state: do not withdraw the gore® viabahn® vbx balloon expandable endoprosthesis back into the introducer sheath once the endoprosthesis is fully introduced.Withdrawing the gore® viabahn® vbx balloon expandable endoprosthesis back into the sheath can cause dislocation and / or damage to the endoprosthesis, premature deployment, deployment failure, and / or catheter separation.If removal prior to deployment is necessary, withdraw the gore® viabahn® vbx balloon expandable endoprosthesis to a position close to but not into the introducer sheath.Both the gore® viabahn® vbx balloon expandable endoprosthesis and introducer sheath can then be removed in tandem.After removal, do not reuse the gore® viabahn® vbx balloon expandable endoprosthesis or introducer sheath.W.L.Gore & associates, inc.(gore) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by gore, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Blank fields present on this report include required fields and fields determined to be not applicable.Blank required fields indicate that the information was not provided, was deemed unavailable or was not applicable.This report does not constitute an admission or a conclusion by fda, gore, or its associates that the device, gore or its associates caused or contributed to the event described in the report.In particular, this report does not constitute a legal admission by anyone that the product described in this report has any defects or has malfunctioned, as defined from a legal standpoint.These words are included in the report and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.
|
Provided images were evaluated: clinical imaging specialist performed the imaging evaluation: two jpgs were submitted for evaluation.In image 1 the arrow suggests a ¿bunched¿ graft.Location cannot be verified as image is magnified and anatomy cannot be seen.Image 2 shows a graft in what appears to be the thoracic area, as ribs are visualized.Unable to identify the grafts or anatomy with available image set.Updated: applicable ifu for gore® viabahn® vbx balloon expandable endoprosthesis warnings section state: after removal, do not reuse the gore® viabahn® vbx balloon expandable endoprosthesis or introducer sheath.
|