Catalog Number 1804225-38 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Non specific EKG/ECG Changes (1817); High Blood Pressure/ Hypertension (1908); Thrombosis/Thrombus (4440)
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Event Date 10/16/2023 |
Event Type
Injury
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Event Description
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It was reported that on (b)(6) 2023, the patient, with a history of chronic ischemic heart disease and non-st elevation myocardial infarction, had two xience skypoint (2.25x38mm, 3.0x38mm) stents implanted.On (b)(6) 2023, the patient was re-admitted with chronic ischemic heart disease and post procedural cardiac disturbances.On (b)(6) 2023, the patient was re-admitted with chronic ischemic heart disease and hypertensive heart.Thrombectomy was performed and respiratory ventilation for 24-96 consecutive hours.Discharged on (b)(6) 2023 to home with home health.No additional information was provided.
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Manufacturer Narrative
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The device was not returned for analysis.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 effect(s), and the relationship to the product, if any, cannot be determined; however, the subsequent treatment appears 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; therefore, no product-related corrective action will be implemented in this case.
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Search Alerts/Recalls
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