Model Number DBEC-125 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Myocardial Infarction (1969); Vascular Dissection (3160); Thrombosis/Thrombus (4440)
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Event Date 02/03/2023 |
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 use manual states that vascular dissection and thrombus are potential adverse events that may occur and/or require intervention with use of the system.The device history record for the reported oad could not be reviewed as the lot number was not provided.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.Csi id: (b)(4).
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Event Description
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Following use of a drug eluted stent, angiographic imaging observed a major dissection in the proximal left anterior descending artery.Optical coherence tomography detected thrombus.The clinical event committee reviewed the images and concluded that the diamondback 360 coronary orbital atherectomy device may have contributed.No further information is available.
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Event Description
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Following use of a drug eluted stent, angiographic imaging observed a major dissection in the proximal left anterior descending artery.Optical coherence tomography detected thrombus.The clinical event committee reviewed the images and concluded that the diamondback 360 coronary orbital atherectomy device (oad) may have contributed.Additional information was received from the clinical event committee (cec) and the cec concluded that myocardial infarction was possibly related to the oad.No further information is available.
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Manufacturer Narrative
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Investigation conclusion code 22: the diamondback 360® coronary orbital atherectomy system instructions for use manual states that myocardial infarction is a potential adverse event that may occur and/or require intervention with use of the system.Csi id: (b)(4).
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Search Alerts/Recalls
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