|
On (b)(6) 2025, a patient underwent an original implant procedure during which several i-cast stents were placed, including covered stents in the renal arteries through small fenestrations (sizes: i-cast 6x22 mm on the right and 7x22 mm on the left, with 5-7 mm overlap inside the aorta).The neck anatomy was parallel, and ballooning was performed at all contralateral junction points, using a 10x2 balloon to flare the intra-aortic segment of the covered stent.Although the device was inspected prior to use and the instructions for use (ifu) were followed, a completion angiogram revealed an endoleak at the distal end in the bifurcated abdominal aorta, raising concerns about a potential crotch tear at the bifurcation.Approximately 30 days later, a follow-up scan confirmed the presence of an endoleak, which was identified as a type iii endoleak between the distal graft and leg graft.The patient required reintervention, and a completion graft was reintroduced to realign the original graft, followed by post-implantation re-ballooning.The physician, after reviewing the case, believed that aggressive ballooning may have contributed to the problem.No adverse events were reported, and although the graft could not be deployed in the target zone, no difficulties were experienced during deployment, and the patient¿s anatomy was not tortuous.A cook representative was present for the case, but it remains unknown whether any part of the procedure was performed off-label or whether the patient was on anticoagulants.Pre-operative images were available, and planning and sizing information was provided.Ultimately, the patient had to undergo additional procedures to address the endoleak, but there was no evidence of stent detachment, inadequate barb engagement, aneurysm progression, or material fracture of the graft.
|
