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Model Number 10666 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Chest Pain (1776); Ischemia (1942); Myocardial Infarction (1969)
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Event Date 01/18/2022 |
Event Type
Death
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Event Description
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It was reported that a patient death occurred.Vascular access was obtained via the radial artery.A percutaneous coronary intervention was performed on a left circumflex (lcx) to a long lesion located in the left anterior descending artery (lad).A 6f guide catheter and a bare metal wire (bmw) were used.A 28 x 2.75 promus premier select stent was advanced to the lcx for spot stenting.To cover the long lesion in the lad, a 2.5 x 38 synergy stent was deployed.Following stent deployment, a 2.5 x 12 non compliant balloon (nc) was advanced to post dilate the lesion.The procedure was completed with these devices.Immediately following the procedure, the patient experienced chest pain, and the vessel was noted to be totally occluded.The patient had experienced a myocardial infarction and ischemia, and the patient passed away.
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Event Description
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It was reported that a patient death occurred.Vascular access was obtained via the radial artery.A percutaneous coronary intervention was performed on a left circumflex (lcx) to a long lesion located in the left anterior descending artery (lad).A 6f guide catheter and a bare metal wire (bmw) were used.A 28 x 2.75 promus premier select stent was advanced to the lcx for spot stenting.To cover the long lesion in the lad, a 2.5 x 38 synergy stent was deployed.Following stent deployment, a 2.5 x 12 non compliant balloon (nc) was advanced to post dilate the lesion.The procedure was completed with these devices.Immediately following the procedure, the patient experienced chest pain, and the vessel was noted to be totally occluded.The patient had experienced a myocardial infarction and ischemia, and the patient passed away.
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Search Alerts/Recalls
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