(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.Angina and thrombosis are listed in the xience xpedition everolimus eluting coronary stent systems instructions for use as known patient effects of coronary stenting procedures.Based on the case information, a conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined.A review of the lot history record and complaint history of the reported lot could not be conducted because the lot number was not provided.Based on the information reviewed, there is no indication of a product quality issue with respect to manufacture, design or labeling.
|
It was reported that the procedure on (b)(6) 2014 was to treat a mildly tortuous and mildly calcified lesion in the first diagonal artery.The patient presented with acute myocardial infarction (ami) a 2.5x15mm xience xpedition stent was implanted.On (b)(6) 2016 the patient was re-admitted and presented with chest pain.Thrombosis was confirmed with an intravascular ultrasound in the stented segment.Thrombus aspiration was performed and an unknown stent was deployed, which reconstructed the blood flow.The physician made a comment stating, "it is assumed there is no issue with the stent itself.The patient has been taking plavix.However, there are a certain number of patients on whom plavix does not take effect.It seems plavix is not effective on this patient.Plavix was replaced with effient." the outcome was successful and the patient is in good condition.No additional information was provided.
|