MEDTRONIC IRELAND ENDURANT II ILIAC STENT GRAFT; SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TR
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Model Number ETLW1624C93EE |
Device Problem
Activation, Positioning or Separation Problem (2906)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/27/2024 |
Event Type
malfunction
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Manufacturer Narrative
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Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
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Event Description
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An endurant limb (etlw1624c93ee) was intended to be implanted during the endovascular treatment of an abdominal aortic aneurysm.It was reported during the index procedure, during deployment of etlw1624c93ee, after two stents of the graft were deployed, the blue handle of the delivery system failed to rotate and release any more of the stents.The trigger did not work either.The delivery system and partially deployed stent graft was withdrawn without any further issues or harm to the patient.Per the physician the cause of the delivery system failure was device related.No additional clinical sequelae were provided, and the patient is fine.
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Manufacturer Narrative
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B5; additional information received; it was reported that the device's packaging and box were in good condition.The device looked fine and no issues were noted prior to insertion into the patient.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
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