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Model Number 9553 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Unspecified Heart Problem (4454); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/01/2023 |
Event Type
Death
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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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Event Description
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Promus premier china registry.It was reported that the patient died.In (b)(6) 2018, the subject was referred for cardiac catheterization.The target lesion 1 was located in the proximal left circumflex artery (lcx) with 90% stenosis and was 28 mm long, with a reference vessel diameter of 2.5 mm.The target lesion 1 was treated with placement of a 2.75 mm x 32 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 and clopidogrel.In (b)(6) 2023, the subject died.At the time of the event the subject was on aspirin and clopidogrel.The primary cause of death was unknown.There was no other action 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).
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Event Description
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Promus premier china registry.It was reported that the patient died.In (b)(6) 2018, the subject was referred for cardiac catheterization.The target lesion 1 was located in the proximal left circumflex artery (lcx) with 90% stenosis and was 28 mm long, with a reference vessel diameter of 2.5 mm.The target lesion 1 was treated with placement of a 2.75 mm x 32 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 and clopidogrel.In (b)(6) 2023, the subject died.At the time of the event the subject was on aspirin and clopidogrel.The primary cause of death was unknown.There was no other action taken to treat the event and it is unknown if an autopsy was performed.It was further reported that the primary cause of death was cardiac related.
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Search Alerts/Recalls
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