Synergy stent 3.0 x 12mm ref no: (b)(4), lot no: 18571589.This stent released from the balloon prior to being deployed, floated to the subclavian and had to be retrieved with a retrieval device, procedure date: (b)(6) 2016, dr.(b)(6), synergy stent 2.25 x 16mm, ref no: (b)(6), lot no: 18463936 on table, but never went in the body.Stent appeared to have come part way off the balloon while on the back table.A second 2.25 x 16 was then used without incident.Company notified.Procedure date: (b)(6) 2015 dr.(b)(6), synergy stent 3.0 x 28mm, ref.No: (b)(4), lot no: 18386132 pulled for case, but not used.Stent was frayed so a 2nd stent same size was pulled and used without incident.Company notified.Diagnosis or reason for use: blockage of coronary artery.
|