W. L. GORE & ASSOCIATES, INC. GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS; ILIAC COVERED STENT, ARTERIAL
|
Back to Search Results |
|
Catalog Number BXA073902J |
Device Problems
Break (1069); Activation Failure (3270); Migration (4003)
|
Patient Problem
Aneurysm (1708)
|
Event Date 02/16/2022 |
Event Type
malfunction
|
Manufacturer Narrative
|
Code "other" was selected as the medical device remains implanted.Return not possible.Use of an additional or alternative device was required to achieve optimal outcome.Problem associated with the device failing to be activated including partial activation.Problem with all or part of an implanted or invasive device moving from its intended location within the body.Tubular support placed inside a blood vessel, canal, or duct to aid healing or relieve an obstruction.The investigation involved communication/interviews (either interpersonal or through technical means, e.G.Phone, e-mail) with persons close to the adverse event, e.G.Healthcare professionals (doctors, nurses etc.), the affected patient(s) or other users including, where appropriate, relatives or others engaged in caring for the affected patient.The actual device involved in the adverse event was not returned for testing despite requests by manufacturer.Medical device remains implanted.No investigation can be performed (no serial number available and no device return), therefore no results will be obtained.The investigation findings do not lead to a clear conclusion about the cause of the reported adverse event.
|
|
Event Description
|
The following information was reported to gore: on (b)(6) 2022, this patient underwent a thoracic endovascular aortic repair with chimney technic using a gore® viabahn® vbx balloon expandable endoprosthesis (vbx device / 7-39).The vbx device was to be implanted in the left subclavian artery.After implanting a non-gore stent graft (cook zenith alpha ®) in the aorta, the vbx device was deployed at the target site.The distal side of the vbx stent graft was expanded, but the proximal side of the vbx stent graft was not expanded.The balloon of the vbx device was thought to be ruptured, and the vbx balloon was attempted to remove, but it didn¿t succeed.After it became a little easier to remove with the attempts of poking the vbx device using a tip of a non-gore balloon (6mm-2cm) several times, the vbx balloon was finally removed from the patient.However, when the vbx balloon was removed, the vbx stent graft migrated.The unexpanded part of the vbx stent graft was expanded with again using a non-gore balloon (6 mm-2 cm), but it was not fully expanded since the balloon diameter was 6 mm.Subsequently, another vbx device (8l-59) was additionally deployed to cover the area where the first vbx stent graft had migrated, and at that time, the first vbx stent graft was fully expanded.Reportedly, the removed vbx balloon was inflated outside the patient to check for rupture, and the balloon could not be inflated.The patient tolerated the procedure and no consequences to the patient were reported.
|
|
Manufacturer Narrative
|
Revised c1.Revised h10 - cbas® heparin surface incorporates cbas-heparin manufactured from heparin sodium api, which is covalently bound to the device surface and is essentially non-eluting.
|
|
Search Alerts/Recalls
|
|
|