Model Number TV-IL1414140-J |
Device Problems
Unintended Movement (3026); Migration (4003)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/07/2024 |
Event Type
Injury
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Event Description
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The patient was treated for an abdominal aortic aneurysm (aaa) on (b)(6) 2023, with the implant of an alto abdominal aortic graft system.Endologix was made aware on (b)(6) 2024, that the right limb was pulled back slightly.There was no endoleak.Reintervention was completed on 08 march 2024, with the implant of an additional ovation ix iliac limb to extend further into the common.Final patient status was not reported.
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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.H3 other text : device remains implanted.
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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.There are no other equivalent adverse events/incidents for this lot number existing within the endologix complaint handling system.Endologix was unable to perform an evaluation of the device as it remains implanted in the patient.A clinical evaluation of the adverse event/incident was completed.An examination of medical records and/or medical imaging received by endologix shows the reported implant movement was confirmed to be migration of 25 mm with additional endovascular procedure.This is moderately consistent with the reported adverse event/incident.The most likely causation for the implant movement is anatomy related due to the increased infrarenal angulation from 39.2° to 61.8° which likely contributed to the right limb migration.The final patient status remains unknown as it was not made available to endologix.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: h6 medical device problem codes: remove 3026.H6 investigation finding codes: remove 3233.H6 investigation conclusion codes: remove 11.
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Search Alerts/Recalls
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