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Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Stenosis (2263)
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Event Date 08/13/2019 |
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 standard pta balloon catheter was used to treat the anterior tibial artery.Approximately 14 months later the patient was admitted for pain at the right foot and the angiography revealed stenosis of the ostial tibial artery and mild restenosis of the tibial artery treated with a balloon.Reported causality not related to the device, paclitaxel or procedure.Company causality possibly device related, not related to the procedure or paclitaxel.The patient recovered.
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Manufacturer Narrative
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Patient age, weight, year of birth provided.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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