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Catalog Number AB35W07040135 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Patient Problem/Medical Problem (2688)
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Event Date 12/01/2017 |
Event Type
Injury
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Event Description
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During the index procedure, a medtronic standard pta was being used to treat the venous outflow.After repeat balloon angioplasty, venous elastic recoil of the left cephalic vein occurred leading to a placement of a 7x40mm self expanding stent in the cephalic vein outflow tract.The patient recovered.The investigator assessed the event as not related to the index device, procedure or paclitaxel medication.Safety assessed the event as not related to the device or paclitaxel but related to the procedure.
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Manufacturer Narrative
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It was reported that an evercross standard pta was used during index procedure and not admiral extreme as previously reported.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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