(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The device was not returned for evaluation.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, and the relationship to the product, if any, cannot be determined; however the reported treatments appear to be related to circumstances of the procedure.The reported patient effect of dissection is listed in the xience prime everolimus eluting coronary stent system instructions for use as a known patient effect of coronary stenting procedures.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
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It was reported that the procedure was to treat a 90% stenosed, heavily tortuous, and mildly calcified de novo lesion in the mid left anterior descending artery.An ad hoc percutaneous coronary intervention was planned on a patient whom presented with angina.A semi compliant balloon was used for pre-dilatation and a 3.0x18mm xience prime stent was implanted.An unexpected edge dissection was noted post stenting.The dissection was covered with a 3.0x18mm xience prime stent.There was no clinically significant delay in the procedure.No additional information was provided.
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