Model Number 1550275-38 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Ischemic Heart Disease (2493)
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Event Date 02/09/2021 |
Event Type
Injury
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Manufacturer Narrative
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The stent remains in patient.The device will not be returned for evaluation.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.Na.
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Event Description
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It was reported that on (b)(6) 2021 the patient presented with non-st elevated myocardial infarction (nstemi); therefore, the 2.75x38mm xience sierra was implanted.On 2/09/2021 the patient was re-admitted with heart disease and other cardiovascular symptoms.It is unknown what treatment was performed and the final patient outcome is unknown.No additional information was provided.
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Manufacturer Narrative
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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 treatments appear to be related to the operational context of the procedure.There is no indication of a product quality issue with respect to manufacture, design or labeling.H10: addtl mfg narrative: corrected.
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Search Alerts/Recalls
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