Common name: stent, renal and d2b.Product code: nin.This mdr is being filed after the associated complaint was reviewed under remediation protocol (b)(4), complaint/mdr retrospective review and remediation and reassessed as reportable.Additional complaint investigation and record remediation was not performed.
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It was reported that the formula 418 renal balloon-expandable stent would not would not cross the lesion, and when it was removed, it was found to be stuck on the outer sheath, making it unusable.The procedure was completed with a new stent, and there were no injuries or additional procedures reported.
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