Following analysis has been performed on returned product: visual examination: stent was noted to have moved on balloon, approximately 0.
3 cm distally.
Functional testing to assess crossing ability, could not be done on the returned unit, as the stent was already off of balloon.
In addition, measurement of unit's stent retention force, by pull-tesing returned stent on the instron to determine the force required to move the stent on balloon, could also not be performed, as stent was already off balloon.
Dimensional examination found the tip inner diameter, body outer diameter, and stent profile were found to be within dimensional specifications.
Device history record review: this is first complaint of this type reported for this sterile lot number up to this date.
Review of mfg records for this product revealed stent retention values measured for this lot during quality control testing to be above minimum acceptable criteria.
Exact cause of crossing difficulty could not be determined.
Many different factors can affect successful crossing of a lesion using this type of catheter.
The exact conditions present during actual clinical procedure can not be duplicated in the product performance laboratory.
In addition, the exact cause for the stent coming off the balloon could also not be determined, but withdrawal of sds into guiding catheter is contraindicated in the instructions for use for this same reason.
Conclusion: complaint confirmed for stent moving on balloon.
Cause for stent movement appears related to withdrawal of sds through guiding catheter.
Exact cause for difficulty crossing lesion could not be determined.
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