The patient was treated for an abdominal aortic aneurysm (aaa) with the alto abdominal stent graft system.Two (2) days post-initial procedure, the patient was suffering from left leg pain, and their leg felt cold.A computerized tomography scan identified that the left limb was thrombosed and collapsed.Reintervention was completed with the implant of two (2) medtronic limbs higher than the bifurcation.The final patient status was reported to be critical; however, stable.
|
The reported adverse event/incident was investigated in alignment with endologix operating procedures and work instructions.Where possible, it is endologix practice to make at least three good faith efforts to retrieve a reported adverse event/incident-related device as well as medical records and medical imaging.An evaluation of the manufacturing record was completed.A review of the part number/lot number combination needed for device identification shows the device to have been properly manufactured and released in accordance with the device master record.An evaluation of the device could not be completed.The device was not returned to endologix for evaluation because the device remains implanted.A clinical evaluation of the adverse event/incident was completed.An examination of medical records and/or medical imaging received by endologix shows the ovation ix iliac limb occlusion, collapsed stent (left iliac limb) and additional endovascular procedure are confirmed.This is consistent with the reported event.Device, user, procedure or anatomy relatedness of this complaint could not be determined.Procedure related harms for this complaint could not be determined.Though a definitive root cause cannot be determined, the conicity of the neck measured off label at 25% and the first 1/2 ring of the iliac limbs were in the 46-degree infrarenal angulation.It is unclear if either of these factors contributed to the event.The final patient status was reported to be critical but stable.No additional investigation of this reported adverse event/incident is planned.However, should additional information relevant to the investigation outcome become available, a follow-up report will be submitted.Endologix will continue to monitor this and similar adverse events/incidents.H6: investigation finding codes - remove code 3233.H6: investigation conclusion codes - remove code 11.
|