(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.Concomitant products.Stent: xience alpine 3.0 x 18 mm, 3.25 x 8 mm.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.There is no indication of a product quality issue with respect to manufacture, design or labeling.
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It was reported that three xience alpine stents (2.75x23mm, 3.0x18mm, 3.25x8mm) were implanted on (b)(6) 2017.On (b)(6) 2017, the patient was re-admitted with cardiovascular symptoms including syncope.It was further reported that on (b)(6) 2017, the patient was re-admitted again with angiodysplasia of stomach.Surgical intervention was performed.The final patient outcome is unknown.No additional information was provided.
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