The patient was implanted with the alto stent graft system to treat an abdominal aortic aneurysm (aaa).The aortic body was deployed, and polymer was injected.At the 14 minute mark after the polymer was injected, the integrated balloon was inflated; however, the balloon ruptured before injecting the maximum amount of fluid of (12 ml).It was also noted that there was no excessive ballooning or manipulation performed.There was tortuosity of the aortic neck and no calcification.The physician removed the delivery system and used non-endologix balloon for touch-up.The remainder of the procedure was completed without complications.The device is not available for return.Note: the device did not contribute to death or serious injury but could have based on a similar event(s) with the same failure mode occurring within the last two (2) years that did cause or contribute to death or serious injury of the patient and/or user.
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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 at the user facility.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 balloon rupture is unconfirmed.This is not consistent with the reported adverse event/incident.Device, user, procedure or anatomy relatedness of this complaint could not be determined.Procedure related harms for this complaint could not be determined.The final patient status was reported 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.
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