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Catalog Number VBH131002 |
Device Problem
Fluid/Blood Leak (1250)
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Patient Problems
Death (1802); Extravasation (1842)
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Event Date 03/26/2014 |
Event Type
Death
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Event Description
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On (b)(6) 2014, the patient presented with stenotic lesions in the right and left common iliac arteries.Several gore viabahn endoprostheses were used to treat the highly calcified lesions.Two 8x5 gore viabahn endoprostheses were positioned in the proximal left and right arteries.Both devices were deployed simultaneously and then ballooned.A marking pigtail catheter was placed in the aorta for imaging.The contrast injected through the pigtail catheter revealed extravasations.One gore viabahn endoprosthesis was deployed distally, overlapping the first device in the left iliac artery.Further imaging revealed the leak was originating from the distal aorta / bifurcation where heavy calcium was concentrated.A 13x2.5 gore viabahn endoprosthesis was deployed in the distal aorta.Two 9x5 gore viabahn endoprostheses were positioned side-by-side, extending into left and right iliac arteries, and deployed within the 13x2.5 gore viabahn endoprosthesis.Imaging showed continued leakage.A 13x10 gore viabahn endoprosthesis was deployed in the distal aorta, extending into the right iliac artery.The patient was taken to the operating room for a surgical conversion.On (b)(6), 2014, the patient expired.The patient had previous endarterectomy, which the physician was not aware of prior to this procedure.
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Manufacturer Narrative
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Review of device manufacturing record history confirmed device met pre-release specifications.Concomitant medical products - additional gore viabahn endoprosthesis implanted during same procedure: lot# 10558474, mfr report #2017233-2014-00214; lot# 11191954, mfr report #2017233-2014-00212; lot# 11985920, mfr report #2017233-2014-00215; lot# 11711479, mfr report #2017233-2014-00216; lot# 11911825, mfr report #2017233-2014-00213; lot# 10990903, mfr report #2017233-2014-00210.
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Search Alerts/Recalls
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