The device history record (dhr) review confirms that the device met all material, assembly and performance specifications.During visual inspection, the flow diverter was returned in its deployed state and was noted to be deformed.The delivery catheter was damaged at 2cm from the distal end and the stabilizer was kinked at 4cm from the distal end.The flow diverter was found deployed; therefore, a full functional testing could not be performed.The stabilizer was removed from the catheter without any difficulty.A patency test was performed on the catheter and friction was experienced at the location of the damage to the distal end.As per the additional information, there were no anomalies noted to the stent delivery system prior to use and the device was prepared as per direction for use (dfu).There was a 3-hour surgical delay; however, did not cause any serious injury to the patient.The patient¿s anatomy was very tortuous.It is probable that the severe tortuosity of the patient¿s anatomy caused the as reported difficulty to deploy the stent and the damage noted to the returned device.It is also probable that the flow diverter was deployed prematurely during removal of the device.An assignable cause of procedural factors was assigned to the as reported issue 'nv- stent failed/ unable to deploy' and the as analyzed issues 'nv- stent deployed prematurely outside patient', 'nv ¿ stent delivery catheter deformed', ' nv ¿ stent stabilizer kinked/ bent', 'nv ¿ stent deformed' and 'nv ¿ catheter friction', as the issue is associated with a product that meets stryker design and manufacture specifications and was used in according with the dfu but due to procedural and/or anatomical factors during use, the product performance was limited.
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