It was reported that the procedure was performed to treat a de novo lesion in the mid right coronary artery with mild tortuosity and 88% stenosis.A 3.00 x 28 mm xience xpedition stent delivery system (sds) was advanced against resistance from the anatomy.On deployment of the stent, the sds jumped [moved] resulting in a dissection.Due to the movement of the sds, the stent was not properly apposed to the vessel wall.An additional 3.00 x 28 mm xience xpedition stent was deployed to embed the poorly apposed stent in the vessel wall and treat the dissection.The patient was reported to be recovering well post procedure.No additional information was provided.
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(b)(4).The device was not returned for analysis.The reported patient effect of a dissection is listed in the xience xpedition, everolimus eluting coronary stent system, instructions for use as a known patient effect of coronary stenting procedures.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history did not indicate a lot specific quality issue.The investigation determined a conclusive cause for the reported difficult to deploy (wall apposition) cannot be determined; however, the reported physical resistance and subsequent treatment appear to be related to the circumstances of the procedure.A conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
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