(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.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.
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It was reported that a 2.5 x 33 mm and 2.25 x 28 mm xience alpine stents were implanted on (b)(6) 2017.On (b)(6) 2017, the patient was re-admitted with cardiovascular symptoms including congestive heart failure.On (b)(6) 2017, the patient presented with syncope.Although the treatment performed is unspecified, the fact that rehospitalization occurred indicates that some form of treatment was performed.The final patient outcome is unknown.No additional information was provided.
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