The incident information was reviewed; however, there was no reported device malfunction and the product was not returned.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.The reported patient effect of dissection is listed in the xience prime everolimus eluting coronary stent systems, instructions for use, as a known patient effect of coronary stenting procedures.A conclusive cause for the reported patient effects and the relationship to the product, if any, cannot be determined.Additionally, treatment appears to be related to circumstances of the procedure.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
|
It was reported that the procedure was performed to treat a 90% stenosed, moderately tortuous, and heavily calcified de novo lesion in the left anterior descending artery.Following pre-dilatation, a 2.5x23mm xience prime stent was deployed; however, a distal edge dissection was noted.Another unspecified xience prime stent was used to successfully cover the dissection.There were no adverse patient sequela and no clinically significant delay in the procedure.No additional information was provided.
|