Model Number 10618 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problems
Death (1802); Thrombosis (2100); Sudden Cardiac Death (2510)
|
Event Date 08/23/2018 |
Event Type
Death
|
Manufacturer Narrative
|
Device is a combination product.
|
|
Event Description
|
It was reported that subacute thrombosis and death occurred.The de novo target lesion was located in the left anterior descending artery.The 2.75 x 16 mm synergy stent was implanted successfully and was considered well positioned and well apposed.There was no vessel dissection or perforation.The patient was under observation for nine days and after that the patient died suddenly of cardiac arrest.
|
|
Manufacturer Narrative
|
Device is a combination product.
|
|
Event Description
|
It was reported that subacute thrombosis and death occurred.The de novo target lesion was located in the left anterior descending artery.The 2.75 x 16 mm synergy stent was implanted successfully and was considered well positioned and well apposed.There was no vessel dissection or perforation.The patient was under observation for nine days and after that the patient died suddenly of cardiac arrest it was further reported that lesion was 80-90% stenosed with mild tortuosity and mild calcification.Chest pain lead to the discovery of the thrombosis.The thrombosis was under physician observation.The patient was on standard antiplatelet therapy.
|
|
Search Alerts/Recalls
|