Model Number 10674 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Chest Pain (1776); Thrombosis (2100); Obstruction/Occlusion (2422)
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Event Date 07/20/2020 |
Event Type
Injury
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Manufacturer Narrative
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Device is a combination product.
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Event Description
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It was reported that a stent was blocked and chest pain occurred.On (b)(6) 2020, a primary angioplasty was performed.Vascular access was obtained via the radial artery.The de novo target lesion was located in the mid left anterior descending artery (lad).A 24 x 2.50 promus elite stent was advanced to the mid lad and deployed.The procedure was completed and no patient complications resulted in relation to this procedure.On (b)(6) 2020 the patient presented with chest pain and an angiography revealed that the stent had been completely blocked.A 16 x 2.5 promus elite stent was advanced and deployed to regain the flow.No additional patient complications were reported in relation to this event.
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Manufacturer Narrative
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Device is a combination product.
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Event Description
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It was reported that a stent was blocked and chest pain occurred.On (b)(6) 2020, a pimary angioplasty was performed.Vascular access was obtained via the radial artery.The de novo target lesion was located in the mid left anterior descending artery (lad).A 24 x 2.50 promus elite stent was advanced to the mid lad and deployed.The procedure was completed and no patient complications resulted in relation to this procedure.On (b)(6) 2020 the patient presented with chest pain and an angiography revealed that the stent had been completely blocked.A 16 x 2.5 promus elite stent was advanced and deployed in attempt to regain the flow.No additional patient complications were reported in relation to this event.It was later reported that the de novo target lesion was located in the 95% stenosed mid left anterior descending (lad).No patient complications were reported in relation to this event.The patient was reported to be stable following the procedure and discharged as per regular protocol.
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Manufacturer Narrative
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Correction: h6: patient codes: changed from obstruction 2422 to thrombosis 2100.
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Event Description
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It was reported that a stent was blocked and chest pain occurred.On (b)(6) 2020, a pimary angioplasty was performed.Vascular access was obtained via the radial artery.The de novo target lesion was located in the mid left anterior descending artery (lad).A 24 x 2.50 promus elite stent was advanced to the mid lad and deployed.The procedure was completed and no patient complications resulted in relation to this procedure.On (b)(6) 2020 the patient presented with chest pain and an angiography revealed that the stent had been completely blocked.A 16 x 2.5 promus elite stent was advanced and deployed in attempt to regain the flow.No additional patient complications were reported in relation to this event.It was later reported that the de novo target lesion was located in the 95% stenosed mid left anterior descending (lad).No patient complications were reported in relation to this event.The patient was reported to be stable following the procedure and discharged as per regular protocol.It was later reported that on (b)(6) 2020, an ecg showed minimal st elevation.A coronary angiography (cag) of the mid total left anterior descending artery (lad) was then performed and revealed stent thrombosis.It was noted that the reason for chest pain was due to stent thrombosis.A balloon was advanced to the target lesion for dilatation.Despite many medications, mild residual thrombus was present.A percutaneous transluminal coronary angioplasty (ptca) was then performed on the mid lad and the patient was stented.The patient was discharged with aspirin 75, brilinta 90, and statin 40 mg.No additional patient complications were reported in relation to this event.
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Search Alerts/Recalls
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