The device was not returned for evaluation.The reported patient effect(s) of dissection is listed in the xience xpedition everolimus eluting coronary stent system instructions for use, as a known patient effect(s) of coronary stenting procedures.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.A conclusive cause for the reported patient effect(s), and the relationship to the product, if any, cannot be determined.However, the treatment appears to be related to the 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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It was reported that the procedure was performed to treat a 90% stenosed, heavily tortuous and heavily calcified lesion in the right coronary artery (rca).A 3.0x38mm xience xpedition stent was deployed at 10 atmospheres (atms).Post-dilatation was performed with a 3.5x12mm nc traveler balloon at 18 atms; however, a distal dissection was noted.A 3.0x12mm xience xpedition stent was used to successfully treat the dissection.There was no adverse patient sequela and no clinically significant delay in the procedure.No additional information was provided.
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