Age at time of event: 18 years or older.Returned product consisted of an epic self-expanding stent system.The outer sheath, tip, inner sheath and the remainder of the device were checked for damage.Visual and microscopic examination revealed no damages.The yellow lock is still in the manufactured position.The distal end of the middle sheath is still in contact with the proximal end of the tip.The stent is sticking out approximately 4.5mm from the distal end of the middle sheath.The rack measures approximately 6.1cm from the handle to the pull grip.There is blood present in the middle sheath and on the stent.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis confirmed the stent inadvertently deployed.The presence of blood inside the device indicates this device was used in a procedure and likely entered the patient which is contrary to the reported information.There is no visible damage to the device that could have contributed to the stent being inadvertently deployed.The thumbwheel does not appear to have been unintentionally moved because the middle sheath is still in contact with the proximal end of the tip.Since the device appears to be used it is likely that the stent inadvertently deployed because of procedural factors.
|