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 investigation was unable to determine a conclusive cause for the reported unintended system motion/difficult to deploy and malposition of the stent; however, the reported difficult to advance appears to be related to the circumstances of the procedure.There is no indication of a product quality issue with respect to manufacture, design or labeling.
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It was reported that the procedure was to treat a heavily tortuous proximal right coronary artery (prca).An unspecified guide catheter was advanced through the left radial; however, the device caused a dissection.The dissection was covered with an unspecified stent.The 4.0x18mm xience skypoint was advanced even though resistance was met with anatomy.The stent was deployed, but watermelon seeded out of the lesion on the balloon and still on the wire to the aorta.The physician pulled back the stent delivery system with the stent to the radial artery and deployed the stent there.Access from the right groin was obtained and another 4x28mm unspecified stent was used to successfully complete the procedure.There were no adverse patient effects and no clinically significant delay.No additional information was provided.
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