Model Number A28-28/C75-O20V |
Device Problems
Material Invagination (1336); Migration (4003)
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Patient Problem
Aneurysm (1708)
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Event Date 09/13/2023 |
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 iteration is afx with duraply.
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Event Description
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The patient was initially implanted with a bifurcated stent graft and a suprarenal aortic extension to treat an abdominal aortic aneurysm (aaa).Approximately seven and a half (7.5) years post initial procedure, during a routine follow up, it was noted that the suprarenal aortic extension has migrated, folded over in the sack, and there is a type1a endoleak.The aaa is now 7.9 cm (centerline measurement).The patient is asymptomatic and is currently being monitored while an intervention is being discussed.
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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 proximal cuff migration, type 1a endoleak, and proximal cuff invagination are confirmed.The aneurysm enlargement is unconfirmed.This is moderately 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 as being monitored pending reintervention.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 afx with duraply.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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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 proximal cuff migration, type 1a endoleak, proximal cuff invagination and additional endovascular procedure are confirmed.The aneurysm enlargement is unconfirmed.This is moderately consistent with the reported adverse event/incident.It was reported the patient had been lost to follow up.This may have contributed to the reported event but could not conclusively be determined.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 as discharged home on postoperative day one in stable condition after the additional endovascular procedure.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: b2: outcomes attributed to adverse events has been updated.B5: describe event or problem has been updated.G3: awareness date has been updated.H10/h11: addtl mfg narrative has been updated.
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Event Description
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The patient was initially implanted with a bifurcated stent graft and a suprarenal aortic extension to treat an abdominal aortic aneurysm (aaa).Approximately seven and a half (7.5) years post initial procedure, during a routine follow up, it was noted that the suprarenal aortic extension has migrated, folded over in the sack, and there is a type1a endoleak.The aaa is now 7.9 cm (centerline measurement).The patient is asymptomatic and is currently being monitored while an intervention is being discussed.Additional information: the physician elected to reline the previously implanted stent grafts with an alto stent graft system on (b)(6) 2023 to successfully resolve this event.The patient was discharged the next day.
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Search Alerts/Recalls
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