Catalog Number BXA077901J |
Device Problem
Collapse (1099)
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Patient Problem
Occlusion (1984)
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Event Date 06/11/2020 |
Event Type
Injury
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Manufacturer Narrative
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The devices remain implanted in the patient, therefore they are not available for direct product analysis.Reference medwatch # 2017233-2020-00442 for other device for this event.Reference medwatch # 2017233-2020-00436 & 2017233-2020-00435 for original event dated (b)(6) 2020.
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Event Description
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Following was reported to gore.On (b)(6) 2020, a patient underwent endovascular treatment of occlusion of the aorta and bilateral iliac arteries using gore® viabahn® vbx balloon expandable endoprosthesis (vbx).It was reported that the iliac arteries were highly calcified, and that the two vbx were placed by kissing stent technique.It was not reported which vbx were placed at which side.The procedure was completed without any issue.In mid (b)(6) 2020, the patient complained pain on the left leg, and she reported that the pain had recurred approximately two weeks after the initial procedure.An examination imaging revealed the vbx at the left common iliac artery was compressed and almost occluded.On (b)(6) 2020, a reintervention was performed.The vbx was relined with additional two stentgraft.The patient tolerated the procedure.(reported under event # (b)(4)).On (b)(6) 2020, it was reported that the two vbxs placed on (b)(6) were compressed and almost occluded.A femoral- femoral bypass is planned.
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Manufacturer Narrative
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Additional manufacturer narrative: c1.Name (#1) (b)(6); manufacturer/compounder: w.L.Gore & associates, inc.Lot #21632320.Cbas® heparin surface incorporates cbas-heparin manufactured from heparin sodium api, which is covalently bound to the device surface and is essentially non-eluting.
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Manufacturer Narrative
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Corrected data: h6.- results code 1.H6.- conclusions code 1.Additional manufacturer narrative: review of the manufacturing records verified that the lot met release requirements.The device was not returned.Consequently, direct product analysis was not possible.Additional information about this event could not be obtained.As a result, no conclusion can be drawn.All information has been placed on file for use in tracking and trending.
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Search Alerts/Recalls
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