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2
ADVERSE EVENTS
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Table 1: Percentage of Patients Experiencing Adverse Events
Adverse Event
8F/6F
Diagnostic
(n=97)
8F
Interventional
(n=106)
6F
Interventional
(n=103)
Minor Complication
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AV Fistula
Deep Vein Thrombosis
Vasovagal Response
Device Non-Deployment
Device Malfunction
Major Complication
Vascular Repair
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Any Complication ‡
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Major Complication
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• Allergic reaction
• Foreign body reaction
• Potentiation of infection
• Inflammation
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