W.L. GORE & ASSOCIATES AORTIC EXCLUDER AAA ENDOPROSTHESIS (C3); SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
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Catalog Number RLT281218 |
Device Problems
Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)
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Patient Problems
Aneurysm (1708); No Code Available (3191)
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Event Date 01/15/2016 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).According to the gore® excluder® endoprosthesis instructions for use (ifu), adverse events that may occur and/or require intervention include, but are not limited to aneurysm enlargement and endoleak.Users are made aware of the risks associated with type ii endoleaks in the ifu and are instructed to consider the risks and benefits discussed in the ifu for each patient before using the devices.The date of event will be used as (b)(6) 2016 - the date of aneurysm enlargement.
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Event Description
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On (b)(6) 2015, this patient underwent endovascular treatment for an abdominal aortic aneurysm measuring 60 mm in diameter, and was implanted with gore® excluder® endoprostheses.The patient tolerated the procedure.It was reported that on (b)(6) 2017, a type ii endoleak was identified and the patient underwent an embolization procedure.No further adverse events have been reported.On (b)(6) 2016, follow-up cta showed that a maximum diameter of the aortic aneurysm/lesion was 64 mm.
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Manufacturer Narrative
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(b)(4).
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Event Description
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It was reported that on (b)(6) 2017, a type ii endoleak was identified and the patient underwent a coil embolization procedure of the iliolumbar artery.On (b)(6) 2018, a type ii endoleak was identified and the patient underwent a coil embolization procedure.The patient tolerated the procedure.No further adverse events have been reported.
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