Catalog Number PAH060502 |
Device Problem
Occlusion Within Device (1423)
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Patient Problems
Death (1802); Hemothorax (1896); Rupture (2208); Injury (2348)
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Event Date 10/27/2014 |
Event Type
Death
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Event Description
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On (b)(6) 2014 the patient was implanted within the (b)(4) with a conformable gore® tag® thoracic endoprosthesis to treat a penetrating aortic ulcer of the paravisceral aorta.The cephalic, superior mesenteric, right and left renal artery were stented in the same procedure with five gore® viabahn® endoprostheses.On (b)(6) 2014 the patient suffered on acute kidney injury.The renal stent grafts showed thrombosis bilaterally.The patient was treated with an arteriovenous fistula (avf) where a gore® acuseal vascular graft was implanted to receive hemodialysis.On (b)(6) 2014 a right hemothorax occurred, caused by endoleak type i proximal and following rupture of the artery.On the same day the patient received an additional conformable gore® tag® thoracic endoprosthesis which was used to seal the rupture.The procedure was converted to open repair.Followed by the procedure the patient passed away on (b)(6) 2014.
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Manufacturer Narrative
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Additional imaging evaluation was performed with focus on the implanted viabahn devices in the cephalic, superior mesenteric, right and left renal artery.
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Manufacturer Narrative
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The review of the manufacturing paperwork verified that this lot met all pre-release specifications.Refer to field b6 for the results of the imaging evaluation.It was reported to gore, that it is not possible to determine the lot numbers of the gore® viabahn® endoprostheses which were implanted in the left and right renal artery and which occluded on (b)(4) 2014.Therefore all five provided lot numbers will be reported to the national competent authority.
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Manufacturer Narrative
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(b)(6).
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Search Alerts/Recalls
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