It was reported that the procedure was to treat a lesion in the distal right coronary artery (rca) and the ostial rca without calcification or tortuosity.Two xience sierra stents, 2.25x23mm and 3.5x12mm, were advanced without resistance and implanted.However, the distal end of the 3.5x12mm xience sierra stent deployed in the ostial rca was hard to visualize during contrast injections and the stent placement was a geographical miss.The distal end of the stent was barely attached to the vessel wall and once the stent delivery system and guide wire were removed without resistance, the stent dislodged.Since the stent cannot be visualized, the dislodged stent was unable to be retrieved and no attempts were made.There was no adverse patient sequelae and there was no clinically significant delay in the procedure.No additional information was provided.
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The device was not returned for analysis.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 similar incidents from this lot.The product was not returned to abbott vascular for analysis as it was discarded by the account.Factors that may cause difficulty visualizing the balloon under fluoroscopy include, but not limited to, the type of contrast solution, missing marker bands, material discrepancies with the balloon markers, patient anatomy, patient disease state, fluoroscopy equipment, and the angle of the x-ray tube on the patient.Factors that may contribute to difficulty deploying the stent leading to stent migration include but are not limited to improper/inadequate crimping at the time of manufacture, patient anatomical morphology, patient disease state, pre-dilatation strategy, inflation, interactions with the patient anatomy, balloon ruptures / leaks, or under-sizing of the vessel.There was no damage noted to the sds or stent during the inspection prior to use which suggests a product deficiency did not contribute to the reported difficulties.The reported poor visibility resulted in the inability to visualize where the dislodged stent migrated to; therefore the stent was not retrieved.The investigation was unable to determine a conclusive cause for the reported poor visibility and stent migration.The reported foreign body in patient and serious illness/impairment/injury appear to be related to operational context of the procedure.There is no indication of a product quality issue with respect to manufacture, design or labeling.
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