Catalog Number RONYX30012X |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Death (1802); Myocardial Infarction (1969); Thrombus (2101); Cardiogenic Shock (2262)
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Event Date 01/01/2019 |
Event Type
Death
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Event Description
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During the index procedure two resolute onyx stents were implanted into the cx and one resolute onyx stent was implanted into the lcma.Approximately 5 months post index procedure, the patient suffered cardiogenic shock.Myocardial infarction of the target vessels- lcx and lm was also reported.The patient was treated with ptca and stenting but passed away.The patients death was classified as non sudden cardiac death.The investigator assessed the event as possibly related to the device and unlikely to be related to anti-platelet medication.
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Manufacturer Narrative
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Additional information: cec adjudicated non-q-wave mi (target vessel), 3rd udmi spontaneous, prox cx, lcma.Cec adjudicated death, cardiac.Cec adjudicated tlr-pci as clinically driven of lcma and cx, reason for revascularization: clinical judgement.Cec adjudicated late stent thrombosis, arc definite- lcma <(>&<)> cx, due to occlusion of left main/lcx in setting of acute mi stent thrombosis.Cec also adjudicated thrombotic occlusion of the study stent did not occur subsequent to repeat pci of the target lesion and the stent thrombosis is not related to a non study stent or to non target lesion.If information is provided in the future, a supplemental report will be issued.
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Manufacturer Narrative
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The patient was taking dual antiplatelet therapy within 24 hours prior to the event.If information is provided in the future, a supplemental report will be issued.
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Manufacturer Narrative
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The investigator assessed the mi as possibly related to the device and not related to anti-platelet medication.Mi was due to in-stent restenosis.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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