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.Based on the information reviewed, there is no indication of a product quality issue.A conclusive cause for the reported patient effect of dissection, and the relationship to the product, if any, cannot be determined; however, the subsequent treatment appears to be related to the operational context of the procedure.Dissection is listed in the instructions for use as a known patient effect of coronary stenting procedures.There is no indication of a product quality issue with respect to manufacture, design or labeling.
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It was reported this was a procedure to treat a heavily calcified, moderately tortuous and 90% stenosed lesion in the left circumflex.A xience v rx 3.5/12mm drug eluting stent (des) was implanted.However, fluoroscopy showed an edge dissection at the proximal end of the stent.An additional stent was implanted to cover the dissection.There was no clinically significant delay in the procedure.No additional information was provided.
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