Other relevant device(s) are: product id: vamf3232c200tu, serial/lot #: (b)(4), ubd: (b)(6) 2020, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.
|
A valiant stent graft system was planned for implantation in a patient for the endovascular treatment of a 65mm diameter thoracic aortic aneurysm.It was reported that during the index procedure, after placement of wires and catheters, the most proximal 24fr valiant stent graft to be implanted was inserted; however, while trying to advance, although the physician was pushing as hard as possible, the delivery system could not be advance.After removal of the device, angiogram showed an occlusion of the distal aorta and proximal common iliac arteries.The physician used a balloon expandable stent in the area and then sequential dilators up to 22 fr to dilate the vessels.The physician then attempted to pass the device again, however, it still would not advance.A 22fr valiant stent graft was then attempted to pass and this was successfully advanced proximally to land just before the left subclavian artery to treat the taa.Another valiant stent graft was placed just above the celiac artery more distally.It was reported the next day, the patient was paralyzed from the waist down.Attempts to place a spinal drain and fluoroscopy drain were not successful.Additionally, a csf drain had also been placed prior to the stent graft procedure.The physician noted a 3-5% risk of paralysis with the taa repair procedure.As per the physician, the cause of the crossing difficulties was due to advanced occlusive disease leading to inability to advance the device.The cause of the paralysis as per the physician cannot be determined.No additional clinical sequelae were reported and the patient will be monitored.
|