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.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 following events were confirmed: aortic and iliac occlusions with lower leg ischemia, intraoperative cranial movement of the suprarenal extension with resultant bilateral renal occlusion, open repair and explant and additional surgical procedure (placement of dialysis catheter and right calf fasciotomy for suspected compartment syndrome).This is moderately consistent with the reported adverse event/incident.The clinical evaluation shows the most likely causation for this event was procedure and user related.The procedure related harms identified were acute renal failure, cardiac arrest and an additional surgical procedure.The aortic and iliac occlusions are likely related to the pre existing aorto-iliac occlusive disease (off-label).It is unclear what caused the intraoperative cranial movement of the suprarenal extension.The bilateral renal occlusions were likely related to the intraoperative cranial movement, the surgical conversion related to the renal occlusions, the additional surgical procedure likely related to the renal occlusions and the cardiac arrest was likely related to the renal occlusions in association with the aorta iliac occlusive disease.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.Device iteration is afx2.Corrections: g4: date received by manufacturer - updated.H6: result code: remove code 3233.H6: conclusion code: remove code 11.
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