Model Number BEA28-100/I20-40 |
Device Problems
Off-Label Use (1494); Device-Device Incompatibility (2919)
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Event Date 11/01/2022 |
Event Type
Injury
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Manufacturer Narrative
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The device involved in this event will not be returned for evaluation as it remains implanted in the patient.Patient medical records and imaging studies will be requested for further evaluation by the clinical specialist.If additional information pertinent to the incident is obtained, a follow-up report will be submitted.Device remains implanted.
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Event Description
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The patient was initially treated for an abdominal aortic aneurysm (aaa) with implant of an afx2 bifurcated stent graft, two gore (non-endologix) and two endurant (non-endologix) stent grafts.Both the left and right internal iliac arteries were occluded by coils prior to the endovascular aortic repair (evar) procedure.A gore leg was implanted in the right iliac and gore iliac extender was implanted in the left iliac.Then an endurant aortic extender and an iliac extension were implanted below the renal artery.Next, the afx2 bifurcated stent graft was implanted.During deployment of the afx2, the endurant iliac extension migrated towards the aneurysm.This initial procedure is outside the indications of use (off-label) due to the use of adjunctive devices not compatible with afx system per the ifu.It was reported that in july 2022 (exact date is unknown) coil occlusion was performed for type 2 (non-device related) endoleak.Additionally, in november 2022 (exact date is unknown), an indeterminate type endoleak was observed on follow-up computed tomography (ct) images.
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Manufacturer Narrative
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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 indeterminate endoleak is unconfirmed.This is not consistent with the reported adverse event/incident.This is an off label - concomitant use with products outside the ifu.Device, user, procedure or anatomy relatedness of this complaint could not be determined with the medical records available for review.Procedure related harms for this complaint could not be determined.The final patient status was reported being 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.Device iteration is afx2.Corrections: g3: awareness date has been updated.H6: investigation finding codes: remove code 3233.H6: investigation conclusion codes: remove code 11.
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Search Alerts/Recalls
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