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Model Number UNK-NV-CRAGG-MC |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Hematoma (1884); Ischemia (1942); Pseudoaneurysm (2605)
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Event Date 07/09/2019 |
Event Type
Injury
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Manufacturer Narrative
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Caymaz, i., nurili, f., kolcak, o., aras, o., <(&)> gumus, b.(2020).Success and reliability of extrafemoral exoseal vascular closure device: ¿off-label¿ usage.Interventional medicine and applied science, 11(3), 182¿186.Https://doi.Org/10.1556/1646.11.2019.22.A.2.This value is the average age of the patients reported in the article as specific patients could not be identified.This value reflects the gender of the majority of the patients reported in the article as specific patients could not be identified.Please note that this date is based off of the date of publication of the article as the event dates were not provided in the published literature.It was not possible to ascertain specific device information from the article or to match the events reported with previously reported events.Correspondence has been sent to the author of the article inquiring about individual patient information and additional information regarding the reported events.If information is provided in the future, a supplemental report will be issued.
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Event Description
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Caymaz, i., nurili, f., kolcak, o., aras, o., <(&)> gumus, b.(2020).Success and reliability of extrafemoral exoseal vascular closure device: ¿off-label¿ usage.Interventional medicine and applied science, 11(3), 182¿186.Https://doi.Org/10.1556/1646.11.2019.22.Summary: the aim of this study is to present the reliability and efficacy of exoseal vascular closure device (evcd) for closure of e xtrafemoral punctures.Materials and methods: all patients who were treated with evcd following arterial endovascular treatment involving an extrafemoral puncture between april 2013 and january 2014 were examined retrospectively.This study included 11 patients (4 women and 7 men between the ages of 48 and 87 years; average age = 65 years).A total of 13 procedures were performed in 11 patients involving the following access routes: brachial artery (n = 5), popliteal artery (n = 4), and polytetrafluoroethylene graft (n = 4).Identified events: the patient had an unsuccessful procedure.The hemostasis was maintained with manual compression within 5 minutes, however a profound hematoma (10cm in diameter) was observed approximately 12 hours later.The hematoma was compressed and a bandage was applied.The area of the hematoma grew and an angiography was performed where a pseudoaneurysm was observed.The pseudoaneurysm was treated with a covered stent.The patient had a minor complication where they suffered from acute critical limb ischemia.The patient initially presented with sudden cold feet.In addition, the patient had a pseudoaneurysm as well.The patient had a history of leriche syndrome and a bypass operation.The patient was using warfarin as an anticoagulant.See attached literature article.
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Search Alerts/Recalls
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