The patient was being implanted with the alto stent graft system to treat an abdominal aortic aneurysm (aaa).It was reported that the patient had a short aortic neck measuring approximately 10mm, with the left renal artery being a couple of millimeters lower than the right.There was both thrombus and calcium at the levels of both renals.The procedure went well and no endoleaks were noticed; however, the left renal was barely visible.The physician took a simmons 2 (non-endologix) catheter up and got a picture of the left renal at the end of the procedure and left the case confident that all was well.It was reported that the next day the patient had stopped making urine.An ultrasound was taken and showed there was no flow in both renals.A computed tomography (ct) scan was not taken because the patients¿ creatinine had also risen.The physician stated there was clot in both renals, and that the left was slightly worse than the right.It is unknown if the stent graft had covered the renals as the physician had not looked.It was noted that with the manipulation of the graft, along with the calcium and thrombus, there were flow compromised.The physician elected to perform bypasses on both renals to resolve this event.The final patient status was reported as stable and doing well.
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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.The review confirms there were no manufacturing or processing non-conformities identified that would contribute to the reported adverse event/incident.An evaluation of the device could not be completed.The device was not returned to endologix for evaluation because it 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 that the renal occlusion and additional surgical procedure complaints are confirmed.This is consistent with the reported adverse event/incident.The complaint is most likely anatomy related.There was stenosis of the renal arteries at index - 60% on left and 45% on the right.This pre existing condition most likely caused the renal thrombosis of the right and slow flow on the left post index procedure.The infrarenal neck was sharply angulated with a juxtarenal angle of 58.1° (should be =60°).This may have contributed to malposition of the device but could not be conclusively determined.It was reported that there was some concern for left renal artery impingement and left renal artery perfusion as the renal artery was barely visible on completion angiogram.The physician used a simmons 2 (non-endologix) catheter to perform arteriogram which confirmed that the left renal artery was patent with good flow at completion of index procedure.Procedure related harms are renal insufficiency and respiratory complications.The final patient status is reported as discharge home on postoperative day fourteen on dialysis.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.
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