Model Number TV-AB2680-N |
Device Problems
Material Invagination (1336); Appropriate Term/Code Not Available (3191)
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Patient Problem
Failure of Implant (1924)
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Event Date 11/29/2021 |
Event Type
Injury
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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.Devices remain 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 the alto abdominal aortic aneurysm stent system.During the initial implant procedure, a type ia endoleak was identified 46-minutes post polymer cure.The physician treated by implanting a gore (non-endologix) vbx balloon expandable stent graft.Subsequent angiography showed a significantly improved seal, however a type ii endoleak (anatomy-related) was noted.The physician elected to monitor the patient.Fifteen (15) days post initial implant, cta (computed tomography angiography) scan identified three separate lumbar arteries communicating with the aneurysm sac (classified as a type ii endoleak), but the physician did not believe the type ia endoleak was still present.Approximately three (3) months later, it was observed that the type ia endoleak had not previously resolved.The physician elected to fill the sac with coils and implant a palmaz stent at the aortic neck.The final angiogram revealed that the type ia and ii endoleaks were successfully resolved.Patient is reportedly doing well.
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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 the type ia endoleak, multiple type ii endoleaks (lumbar) and additional endovascular procedure are confirmed.This is consistent with the reported adverse event/incident.The clinical evaluation also shows reasonable evidence to suggest mild infolding of the first proximal ring.This finding was discovered during an examination of ct (computed tomography) scan dated (b)(6) 2021.The most likely causation for the type ia endoleak and mild infolding is most likely anatomy related due to the proximal neck diameter measuring in-between the 23 and 26mm sizing.No procedure related harms were identified.The final patient status was discharged on the first post operative day home in stable condition.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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Event Description
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The patient was initially treated for an abdominal aortic aneurysm (aaa) with implant of the alto abdominal aortic aneurysm stent system.During the initial implant procedure, a type ia endoleak was identified 46-minutes post polymer cure.The physician treated by implanting a gore (non-endologix) vbx balloon expandable stent graft.Subsequent angiography showed a significantly improved seal, however a type ii endoleak (anatomy-related) was noted.The physician elected to monitor the patient.Fifteen (15) days post initial implant, cta (computed tomography angiography) scan identified three separate lumbar arteries communicating with the aneurysm sac (classified as a type ii endoleak), but the physician did not believe the type ia endoleak was still present.Approximately three (3) months later, it was observed that the type ia endoleak had not previously resolved.The physician elected to fill the sac with coils and implant a palmaz stent at the aortic neck.The final angiogram revealed that the type ia and ii endoleaks were successfully resolved.Patient is reportedly doing well.After the previous report was filed, clinical assessment also shows reasonable evidence to suggest mild infolding of the first proximal ring.This finding was discovered during an examination of ct (computed tomography) scan dated (b)(6) 2021.
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Search Alerts/Recalls
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