Model Number TV-IL1414100-J |
Device Problems
Appropriate Term/Code Not Available (3191); Migration (4003)
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Patient Problems
Aneurysm (1708); Failure of Implant (1924)
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Event Date 12/21/2021 |
Event Type
Injury
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Event Description
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The patient was initially treated for an abdominal aortic aneurysm (aaa) with the alto stent graft system.Eighteen (18) days post initial procedure, a type ib endoleak and a type ii endoleak (non-device related) were identified.Reintervention was completed with implant of an additional ovation ix iliac limb on each side.The patient was reported to be stable post-reintervention.
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Manufacturer Narrative
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The devices involved in this event will not be returned for evaluation and remain implanted in the patient.Patient medical records and imaging studies will be requested for further evaluation by a clinical specialist.If additional information pertinent to the incident is obtained, a follow-up report will be submitted.
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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.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 bilateral type ib endoleak, type ii endoleak (non- device related) of the left internal iliac artery and additional endovascular procedure are confirmed.This is consistent with the reported adverse event/incident.The clinical evaluation also shows that there was evidence to reasonably suggest bilateral cranial iliac stent migration and sac growth (amount not noted) had occurred.There was also a rupture at the index procedure, however it is unclear if this contributed to the reported event.Device, user, procedure or anatomy relatedness of this complaint could not be determined with the lack of medical records and/or imaging available for review.No procedure related harms were identified.The final patient status was reported as being discharged on the second post operative day following 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: b5: describe event or problem - updated g3: date received by manufacturer - updated h6: medical device problem codes: remove code 3191 h6: investigation finding codes: remove code 3233 h6: investigation conclusion codes: remove code 11.
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Event Description
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The patient was initially treated for an abdominal aortic aneurysm (aaa) with the alto stent graft system.Eighteen (18) days post initial procedure, a type ib endoleak and a type ii endoleak (non-device related) were identified.Reintervention was completed with implant of an additional ovation ix iliac limb on each side.The patient was reported to be stable post-reintervention.Additional information: the clinical assessment determined that there was evidence to reasonably suggest bilateral cranial iliac stent migration and aneurysm growth (amount not noted) occurred that was not included in the event as reported.
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Search Alerts/Recalls
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