(b)(4).Non-healthcare professional.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.A conclusive cause for the reported patient effects and the relationship to the product, if any, cannot be determined.The reported patient effect of hypersensitivity is listed in the xience alpine, everolimus eluting coronary stent system (eecss), instructions for use as a known patient effect of coronary stenting procedures.There is no indication of a product quality issue with respect to manufacture, design or labeling of the device.
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It was reported that the procedure was to treat the left anterior descending artery that was approximately 80% stenosed.On (b)(6) 2016, a 3.0 x 12 mm xience alpine stent was implanted; however, the patient began experiencing a rash shortly after the procedure, which has worsened over time.The rash is felt on the underarms, upper thighs, bottom part of the legs and back and occasionally on the left side of the face.The patient stated that the rash and itchy feeling is sporadic.She has been taking gabapentin and another unspecified medication for the rash which make her feel tired.The patient has been consulting her dermatologist and allergist to confirm what is causing the rash.At this time, the cause is undetermined.On (b)(6) 2016, she was re-hospitalized and it was confirmed that the stent had not migrated from the target lesion.The physician stated that two smaller stents may need to be implanted; however, the patient will confirm this with the physician in two weeks.No additional information has been provided.
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