CARDIOVASCULAR SYSTEMS, INC. DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM; CORONARY ATHERECTOMY DEVICE,
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Model Number DBEC-125 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Myocardial Infarction (1969)
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Event Date 12/03/2019 |
Event Type
Injury
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Manufacturer Narrative
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H6 investigation conclusion code 22: the diamondback 360® coronary orbital atherectomy system instructions for user manual states that a myocardial infarction is a potential adverse event that may occur and/or require intervention with use of the system.The results of the investigation are inconclusive since the reported device was not returned for analysis.Based on the information received, the cause of the reported event could not be conclusively determined.The device history record for this oad lot number has been reviewed.No issues or discrepancies were noted during this review that would have contributed to the reported event.The device met material, assembly, and quality control requirements.Csi id: (b)(4).
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Event Description
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The diamondback 360 coronary orbital atherectomy device (oad) was used for treatment in a 3.00mm, 80% stenosed, heavily calcified mid left anterior descending artery (lad).The oad was spun for three treatments on low speed.Angioplasty and stent placement were performed to complete the procedure.Elevated cardiac enzymes were observed.The elevated cardiac enzymes was characterized as a type 4 nstemi myocardial infarction.No further action or treatment were taken and the patient was discharged home.It was unknown if the oad caused or contributed to the elevation of troponins, but it was possible.
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