Catalog Number 1070275-23 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Syncope (1610); Angina (1710); Stenosis (2263)
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Event Date 10/18/2017 |
Event Type
Injury
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Manufacturer Narrative
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(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 angina and stenosis is listed in the xience xpedition, everolimus eluting coronary stent system (eecss), instructions for use (ifu) as known patient effects of coronary stenting procedures.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 of the device.
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Event Description
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It was reported that the procedure was to treat a narrow proximal right coronary artery (rca) that was 90% stenosed and the mid rca that was 80-90% stenosed.On (b)(6) 2014, a 3.0 x 23 mm and a 2.75 x 23 mm xience xpedition stent were implanted in the proximal rca and in the mid rca.The patient was discharged on (b)(6) 2014.On (b)(6) 2017, the patient was re-hospitalized for experiencing angina, pain and recurring loss of consciousness.The patient was diagnosed with coronary heart disease (chd).On (b)(6) 2017, angiography showed that there was 80% restenosis in the 2.75 x 23 mm xience xpedition stent.Therefore, an unspecified balloon dilatation catheter was used, dual anti-platelet and other medication were administered.The patient was discharged from the hospital on (b)(6) 2017.According to the physician, the relationship between the incident and the device is not known.The patient is in stable condition.No additional information was provided.
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Search Alerts/Recalls
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