W.L. GORE & ASSOCIATES GORE VIABAHN VBX BALLOON EXPANDABLE ENDOPROSTHESIS; STENT, ILIAC
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Catalog Number BXA077901J |
Device Problem
Deformation Due to Compressive Stress (2889)
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Patient Problem
Occlusion (1984)
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Event Date 01/14/2020 |
Event Type
Injury
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Manufacturer Narrative
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The second device is being reported under mfr.Report # 2017233-2020-00079.
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Event Description
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The following information was reported to gore: on (b)(6), 2020, this patient underwent endovascular treatment of an iliac artery stenotic occlusion using three gore® viabahn® vbx balloon expandable endoprosthesis for leriche syndrome, also known as aortoiliac occlusive disease.Two vbx devices were deployed in the aortic bifurcation using the kissing stent technique.Another vbx was deployed to extend the left device distally.It was reported that the left popliteal artery was embolized by floating mural thrombus.Thrombus aspiration was performed, and patency was confirmed.The patient tolerated the procedure.On (b)(6) 2020, computed tomography scan image revealed a suspected occlusion.On (b)(6) 2020, the patient underwent a reintervention to treat the occlusion.Angiography and ivus revealed collapse of the two vbx implanted in the aortic bifurcation using the kissing stent technique.Poba was performed on the collapsed part.The patient tolerated this procedure.The physician stated following:
it is speculated that the root cause of the device collapse is the patient's bent waist posture.The ct examination was performed although the patient¿s abi etc.Had not dropped, but the physician was not at ease about the patient's posture during hospitalization.The patient and their family were instructed to correct her posture.The fsa stated: same as the physician's view, the bend in the patient's waist may be the cause.At the time of reintervention, it was planned to deploy a bare metal stent after poba, but only ballooning was performed, because additional treatment could be performed if collapse occurred again.
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Manufacturer Narrative
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B.5.Updated.H.6.Method code 2 added.H.6.Results code 2 added.H.6.Results code 1: 213: a review of the manufacturing records for the device verified the lot met all pre-release specifications.H.6.Conclusion codes updated.
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Event Description
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The following information was reported to gore: on (b)(6) 2020, this patient underwent endovascular treatment of an iliac artery stenotic occlusion using three gore® viabahn® vbx balloon expandable endoprosthesis for leriche syndrome, also known as aortoiliac occlusive disease.Two vbx devices were deployed in the aortic bifurcation using the kissing stent technique.Another vbx was deployed to extend the left device distally.The patient tolerated the procedure.On (b)(6) 2020, computed tomography scan image revealed a suspected occlusion.On (b)(6) 2020, the patient underwent a reintervention to treat the occlusion.Angiography and ivus revealed collapse of the two vbx implanted in the aortic bifurcation using the kissing stent technique.Poba was performed on the collapsed part.The patient tolerated this procedure.The physician stated following: it is speculated that the root cause of the device collapse is the patient's bent waist posture.The ct examination was performed although the patient¿s abi etc.Had not dropped, but the physician was not at ease about the patient's posture during hospitalization.The patient and their family were instructed to correct her posture.The fsa stated: same as the physician's view, the bend in the patient's waist may be the cause.At the time of reintervention, it was planned to deploy a bare metal stent after poba, but only ballooning was performed, because additional treatment could be performed if collapse occurred again.
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