(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 death, hypotension, angina, cardio-respiratory arrest, cardiac failure and thrombosis are listed in the xience sierra, everolimus eluting coronary stent system (eecss), electronic 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 the design, manufacture or labeling of the device.The other three xience sierra stents referenced are filed under separate medwatch report numbers.
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It was reported that the procedure was to treat a mildly tortuous and mildly calcified obtuse marginal branch, the diagonal branch and the left anterior descending artery.A 2.25 x 12 mm xience sierra stent was implanted in the obtuse marginal branch, a 2.25 x 18 mm xience sierra stent was implanted in the diagonal branch and a 2.5 x 38 mm xience sierra stent was implanted in the left anterior descending (lad) artery without any issues.However, the patient complained of discomfort and then became hypotensive and experienced cardiac arrest.Therefore, cardiopulmonary resuscitation (cpr) was started and the patient was intubated.It was noted that there was no flow in the vessels that were stented due to thrombus.Therefore, balloon angioplasty was performed in the proximal circumflex, diagonal and lad arteries.Aspiration was performed to remove the thrombus and a 2.5 x 38 mm xience sierra stent was implanted in the distal lad.Cpr continued; however, the patient expired that same day on (b)(6) 2018.No additional information was provided.
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