MEDTRONIC IRELAND ENDURANT II ILIAC STENT GRAFT; SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
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Model Number ETLW1624C124EE |
Device Problems
Material Deformation (2976); Positioning Problem (3009)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/19/2024 |
Event Type
malfunction
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Event Description
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An endurant ii limb was intended to be implanted during the treatment of a 37.2mm abdominal aortic aneurysm.It was reported during the index procedure, the physician attempted to deliver the stent, however due to the patient's tortuous approach, the stent could not reach the target position after trying to insert it into the body along the guide wire.The shape of the stent had changed considerably due to the tortuous approach and could no longer be used.The device was withdrawn from the patient and was replaced with a new limb of the same size and treatment was successfully completed.Per the physician the cause of the device¿s delivery issues was anatomy related due to the tortuous approach. no additional clinical sequelae were provided and the patient is fine.
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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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Manufacturer Narrative
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Product analysis # (b)(6):one (1) image capturing the endurant device loaded in the product tray was received.The taper tip is curved; it was not possible to determine if there was further deformation to the device based on the image.The reported deformation was confirmed through image review.B5; additional information received : it was confirmed the device was inspected before use and no issues were noted.It was said that the tapered tip became deformed during the delivery attempt.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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Manufacturer Narrative
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Product analysis conclusion: the reported tapered tip deformation and positioning difficulties could not be confirmed on the films received.Lack of pre-implant ct¿s did not allow for a thorough assessment of the pre-implant anatomy.Full procedural angiograms showing the attempted delivery of the endurant limb were not received for a thorough analysis of the event.It is likely the patient anatomy and tortuous access vessels did contribute to the reported events but this could not be confirmed.Analysis of the returned films did not reveal any obvious out of specification stent graft integrity issue.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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