Age at the time of event: 18 years or older.Returned product consisted of an innova self-expanding stent system.The outer sheath, tip, inner sheath and the remainder of the device were checked for damage.Visual examination revealed that the handle is open, the device was returned in several pieces.There are kinks to the inner liner 3.5cm and 5.6cm from the tip.There is a kink to the middle sheath at the distal end of the retainer.Microscopic examination revealed buckling to the middle sheath 3mm, 6mm, and 4.7cm from the distal end of the middle sheath.The stent was deployed and did not return with the device.There is blood on the retainer and in the middle sheath.Inspection of the remainder of the device presented no other damage or irregularities.There was no evidence of any damage or irregularities contributing to the reported crossing difficulty, which could not be confirmed because the clinical circumstances could not be replicated.Product analysis found damages that can potentially cause the device to inadvertently deploy.
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