The patient was initially treated for an abdominal aortic aneurysm (aaa) with implant of the alto abdominal aortic aneurysm stent system.During the initial implant procedure, the integrated balloon ruptured.At the conclusion of the procedure, the patient was noted to have lost a significant volume of blood.The physician performed an angiogram and observed a slight tear in the aorta.Patient was then converted to open repair and a patch was sewn in the torn area.The procedure was completed and the patient is in recovery and doing well.The delivery system is not available for return/evaluation.
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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 was discarded.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 integrated balloon rupture, reported blood loss and surgical conversion are unconfirmed.The aortic neck dissection is confirmed.This is moderately consistent with the reported adverse event/incident.The most likely causation for this event is user related.Per the ifu, the integrated balloon maximum inflation volume for a 34mm aortic body should be 19ml.The physician inflated with 20ml, which could have lead to the aortic neck dissection.The procedure related harm identified was renal failure.The last patient status reported to be in the recovery room doing well.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.Corrections: h6: component codes: remove code 515.H6: investigation finding: remove code 3233.H6: investigation conclusion: remove code 11.
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