(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 analysis.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no similar incidents from this lot.The investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely the device interacted with the moderately tortuous and mildly calcified coronary artery causing the reported physical resistance and subsequent dissection.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 de novo lesion in the moderately tortuous, mildly calcified, mid left anterior descending (lad) coronary artery.A 3.50 x 23 mm xience xpedition stent delivery system (sds) was advanced with resistance felt to the lesion and the stent implant was successfully deployed at 18 atmospheres.Following deployment of the stent implant, a distal edge dissection was observed.A new non-abbott stent implant was successfully used to cover the dissection.There was no reported clinically significant delay in the procedure.No additional information was provided.
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