(b)(4).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 effect(s) of thrombosis is listed in the xience alpine everolimus eluting coronary stent systems instructions for use as a known patient effect of coronary stenting procedures.A conclusive cause for the reported patient effect(s), 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.The xience alpine device is currently not commercially available in the us; however, it is similar to a device sold in the us.
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It was reported that the patient presented emergently with a non-st-elevation myocardial infarction where they were taken to the cath lab and pre-dilated, and a xience alpine 4 x 23 mm stent was deployed in the mid-right coronary artery.During this initial procedure, the patient was given angiomax.After the stent was implanted there was no post-dilatation or imaging performed.Thirty minutes post-procedure, the patient coded and cardiopulmonary resuscitation was successfully administered.The patient then returned to the cath lab where it was discovered via angiography that the stent had thrombosed.The patient was aspirated and post-dilatation was performed with a high pressure, non-compliant balloon.The patient was given heparin and integrilin and was doing well post-procedure.No additional information was provided.
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