W. L. GORE & ASSOCIATES, INC. GORE VIABAHN VBX BALLOON EXPANDABLE ENDOPROSTHESIS; ILIAC COVERED STENT, ARTERIAL
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Model Number BXA097902A |
Device Problem
Deformation Due to Compressive Stress (2889)
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Patient Problem
Stenosis (2263)
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Event Date 05/29/2020 |
Event Type
Injury
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Manufacturer Narrative
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Cbas® heparin surface incorporates cbas-heparin manufactured from heparin sodium api, which is covalently bound to the device surface and is essentially non-eluting.Concomitant medical products and therapy dates: calcium, fish oil, lysine, niacin, vitamin b and c.
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Event Description
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On (b)(6) 2020 the patient underwent endovascular treatment of an aortic aneurysm using investigational tambe devices.Two gore® viabahn® vbx balloon expandable endoprostheses (vbx) were utilized in the patient's superior mesenteric artery (sma).On (b)(6) 2020 branch stenosis of the sma was observed at the transition between the aortic segment and the branch vessel segment in the bridging vbx device.It was reportedly suspected that the cause of the stenosis was the investigational tambe device ¿settling¿ into its final seal position which may have resulted in slight kinking of the sma branch stent.Blood flow was reportedly present.On the same day balloon angioplasty, stenting, and selective angiography of the sma via left brachial cutdown and second order cannulation of the sma was performed.The adverse event was deemed resolved on (b)(6) 2020.There were no further reported issues.
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Manufacturer Narrative
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H6.Investigation findings: code 213 the review of the manufacturing paperwork verified that the lots involved in this event met all pre-release specifications.According to the gore® viabahn® vbx balloon expandable endoprosthesis instructions for use (ifu), hazards and adverse events that may occur include, but are not limited to, device related stenosis.H6.Investigation findings: code 3233 updated to code 213.H6.Investigation conclusions: code 11 updated to code 4315.
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