(b)(4).Internal file number - (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.The reported patient effects of dissection is listed in the xience prime everolimus eluting coronary stent systems instructions for use as known patient effects of coronary stenting procedures.A conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined.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 mildly tortuous and eccentric distal left circumflex artery that was 90% stenosed.Pre-dilatation was done with a 1.5 x 8 mm unspecified balloon dilatation catheter, and a 2.5 x 12 mm xience prime stent was implanted.However, during implantation, a proximal edge dissection occurred which was treated with an unspecified xience prime stent.There was no adverse patient sequela reported.No additional information was provided.
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