Model Number 1804350-28 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Angina (1710); Non specific EKG/ECG Changes (1817); High Blood Pressure/ Hypertension (1908); Thrombosis/Thrombus (4440)
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Event Date 11/05/2021 |
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 chest pain which evolved into an st-segment elevation myocardial infarction (stemi) and ventricular fibrillation cardiopulmonary arrest.Resuscitation using advance cardiac life support was unsuccessful, so venoarterial extracorporeal membrane oxygenation (va-ecmo) was placed.Angiography was performed and noted a mildly tortuous, 100% stenosed lesion in the left anterior descending (lad) artery.A 3.5x28mm xience skypoint drug eluting stent (des) was implanted at the target lesion, improving the patient status.Antiplatelet medication was started.On (b)(6) 2021, va-ecmo was removed, and the patient was alert and conscious.On (b)(6) 2021, the patient experienced chest pain, hypertension and some st changes.Angiography noted the stent was occluded with thrombus.The area was aspirated with most of the thrombus removed, then further dilated, and aspirated, resolving the thrombus.Antithrombolytic medication was administered until (b)(6) 2021.No additional information was provided.
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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 chest pain which evolved into an st-segment elevation myocardial infarction (stemi) and ventricular fibrillation cardiopulmonary arrest.Resuscitation using advance cardiac life support was unsuccessful, so venoarterial extracorporeal membrane oxygenation (va-ecmo) was placed.Angiography was performed and noted a mildly tortuous, 100% stenosed lesion in the left anterior descending (lad) artery.A 3.5x28mm xience skypoint drug eluting stent (des) was implanted at the target lesion, improving the patient status.Antiplatelet medication was started.On (b)(6) 2021, va-ecmo was removed, and the patient was alert and conscious.On (b)(6) 2021, the patient experienced chest pain, hypertension and some st changes.Angiography noted the stent was occluded with thrombus.The area was aspirated with most of the thrombus removed, then further dilated, and aspirated, resolving the thrombus.Antithrombolytic medication was administered until (b)(6) 2021.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.The reported patient effects of angina, hypertension and thrombosis are listed in the xience skypoint everolimus eluting coronary stent systems instructions for use (ifu) as known patient effects of coronary stenting procedures.A conclusive cause for the reported patient effects, 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.Na.
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Search Alerts/Recalls
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