Catalog Number 1011733-38 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Cardiac Arrest (1762); Neurological Deficit/Dysfunction (1982); Cardiogenic Shock (2262)
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Event Date 06/18/2016 |
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 stent remains in the patient.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.
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Event Description
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It was reported that on (b)(6) 2012 a 3.0x38 mm xience prime stent was implanted in the proximal right coronary artery.On (b)(6) 2016, the patient experienced cardiogenic shock, leading to cardiac arrest.Cardiopulmonary resuscitation was performed; however, due to the lack of oxygen, the patient experienced neurological complications.On (b)(6) 2016, slight improvement was noted and the patient was transferred to another hospital for long-term rehabilitation.No additional information was provided.
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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 and there is no indication of a product quality issue with respect to manufacture, design or labeling.
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Search Alerts/Recalls
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