Catalog Number 1009527-23 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Angina (1710); Cardiac Enzyme Elevation (1838); Headache (1880); Stenosis (2263)
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Event Date 01/03/2016 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).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.Based on the case information and related record review, a conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined.Additionally, the treatment appears to be related to the operational context of the procedure.The reported patient effects of angina, headache and stenosis are listed in the xience v everolimus eluting coronary stent systems instructions for use as a known patient effect(s) of coronary stenting procedures.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Based on the information reviewed, there is no indication of a product quality issue with respect to manufacture, design or labeling.The other device is being filed under a separate medwatch report.
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Event Description
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It was reported that on (b)(6) 2011, the patient underwent a coronary stenting procedure with implantation of a 2.75 x 28 mm xience v stent in the proximal left anterior descending (lad) artery, a 2.75 x 28 mm xience v stent in the mid right coronary artery (rca) and a 2.5 x 23 mm xience v stent in the distal rca.On (b)(6) 2016, the patient began experiencing headaches with chest pain for about 1 month.On (b)(6) 2016, the patient was re-hospitalized with headache and chest pain.Troponin levels were elevated.Coronary angiography confirmed in-stent restenosis; however, a device malfunction, such as stent fracture or collapse, could not be confirmed.Intervention was performed on (b)(6) 2016 at the stent located in the mid rca.The patient condition resolved on (b)(6) 2016 and was discharged before echocardiography could be performed to see if a device issue occurred.No additional information was provided.
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Search Alerts/Recalls
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