Caution; Defects And Adverse Events - Mizuho SUGITA Titanium ANEURYSM CLIPS Série Mode D'emploi

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  • FRANÇAIS, page 44
per pulse sequence).
In non-clinical testing, the image artifact caused by
this clip extends approximately 5 mm from this clip
when imaged using a gradient echo pulse sequence
and a 3 Tesla MR system.
NOTE: Do not take the clip applier into the MR
environment.
The clip applier contains material which has
been determined to be MR Unsafe.

12. Caution

Use of this clip is restricted to surgeons with proper
training in the use of this clip.

13. Defects and Adverse Events

1) Serious adverse events
・Displacement of the clip (slippage)
・Ejection of the clip from clip applier
・Breakage of the clip
・Rupture of a cerebral aneurysm
-12-

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