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Model Number 9554 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Heart Failure/Congestive Heart Failure (4446); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/08/2023 |
Event Type
Death
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Event Description
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Promus premier china registry.It was reported that the patient died.In (b)(6) 2019, the subject was referred for cardiac catheterization.The target lesion 1 was located in the proximal right coronary artery (rca) with 100% stenosis and was 34 mm long, with a reference vessel diameter of 2.75 mm.The target lesion 1 was treated with pre-dilation and followed by the placement of a 2.75 mm x 38 mm promus premier stent system.Following post-dilatation, the residual stenosis was noted to be 10%.In (b)(6) 2019, the subject was discharged on aspirin, clopidogrel and other.In (b)(6) 2023, the subject died.At the time of event the subject was on aspirin and clopidogrel.The primary cause of death is unknown.No action was taken to treat the event and it is unknown if an autopsy was performed.
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Manufacturer Narrative
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E1.Initial reporter phone: (b)(6).E1.Initial reporter fax: (b)(6).
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Manufacturer Narrative
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E1.Initial reporter information: (b)(6).
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Event Description
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Promus premier china registry.It was reported that the patient died.In (b)(6) 2019, the subject was referred for cardiac catheterization.The target lesion 1 was located in the proximal right coronary artery (rca) with 100% stenosis and was 34 mm long, with a reference vessel diameter of 2.75 mm.The target lesion 1 was treated with pre-dilation and followed by the placement of a 2.75 mm x 38 mm promus premier stent system.Following post-dilatation, the residual stenosis was noted to be 10%.In (b)(6) 2019, the subject was discharged on aspirin, clopidogrel and other.In (b)(6) 2023, the subject died.At the time of event the subject was on aspirin and clopidogrel.The primary cause of death is unknown.No action was taken to treat the event and it is unknown if an autopsy was performed.It was further reported that the primary cause of death is heart failure.
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Search Alerts/Recalls
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