CARDIOVASCULAR SYSTEMS, INC. DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM; PERIPHERAL ATHERECTOMY DEVICE
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Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Vascular Dissection (3160)
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Event Date 08/24/2010 |
Event Type
Injury
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Manufacturer Narrative
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The results of the investigation are inconclusive since the reported devices were not returned for analysis.Based on the information received, the cause of the reported events could not be conclusively determined.The device history record for the reported oads were unable to be reviewed, as the lot numbers were not provided.Requests for additional information have been made, but no response has been received from the contact identified in the literature article.Therefore, after investigation, csi cannot obtain enough information about each identified patient and/or device mentioned in order to provide a complete report for each reportable event in the article.Therefore, csi is submitting one mdr for the multiple reported events.Date of event: the date entered is the date of publication.Ravikiran korabathina, "orbital atherectomy for symptomatic lower extremity disease," catheterization and cardiovascular interventions 76,3 (2010): 326-32.Https://onlinelibrary.Wiley.Com/doi/abs/10.1002/ccd.22508.Csi id# (b)(4).
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Event Description
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Korabathina et al., 2010 - a literature article was published in 2010 which indicated the following: thirty-one (31) dissections were observed during procedures using a diamondback peripheral orbital atherectomy device (oad).Twenty-four (24) of the dissections were noted after femoral atherectomy.Most of the dissections occurred in the femoral bed and rarely in the tibial arteries.Seventeen (17) of the dissections required stenting to resolve the dissection.Four (4) of the dissections required no treatment.It was noted that after multivariate analysis, the predictors of dissection were: presence of diabetes mellitus, a lower crown-to-reference vessel diameter ratio, and a total atherectomy time longer than 360 seconds.
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Manufacturer Narrative
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Correction: attached referenced literature article - attachment: [record korabathina (2010) - cci - oa for symptomatic lower extremity disease.Pdf].
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Manufacturer Narrative
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Csi id#: (b)(4).
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Event Description
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Per the opinion of the physician, the dissections were caused by the csi oad, most of the dissections were type-a, and there were no clinically significant consequences to the dissections.It was noted that all of the procedures were completed successfully with no further patient complications.Per the contact listed in the article, no additional information is available as the facility has been closed.
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Search Alerts/Recalls
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