(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.Evaluation summary: the device was returned for analysis.The reported difficulty to position and blockage within the device were not confirmed; however, an inner member tear was noted.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no other incidents from this lot.The investigation was unable to determine a conclusive cause for the reported difficulty to position and blockage within the device as they were not confirmed during return device analysis.However, the noted inner member tear was likely due to handling while attempting to insert and advance the guide wire into the inner member.Based on the information reviewed, there is no indication of a product quality issue with respect to manufacture, design or labeling of the device.
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It was reported that the procedure was to treat a non-tortuous, mildly calcified, 100% stenosed lesion in the mid to distal right coronary artery (rca).Resistance advancing a 4.0x23 mm xience sierra stent delivery system (sds) onto a non-abbott guide wire was felt.The non-abbott guide wire was wiped with saline and a second attempt to advance was made, but the sds could not advance.The sds never advanced into the patient anatomy and was removed independently without resistance.There was no damage noted to the sds.It was suspected that there was some kind of blockage in the guide wire lumen.A new same size xience sierra stent was implanted to successfully complete the procedure.There was no reported adverse patient effect or a clinically significant delay in the procedure.No additional information was provided.Return device analysis revealed that the inner member was torn.
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