MAUDE Adverse Event Report: CARDIOVASCULAR SYSTEMS, INC. DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM; PERIPHERAL ATHERECTOMY DEVICE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Vascular Dissection (3160)

Event Date 08/24/2010

Event Type  Injury  

Manufacturer Narrative

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).

Event Description

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.

Manufacturer Narrative

Correction: attached referenced literature article - attachment: [record korabathina (2010) - cci - oa for symptomatic lower extremity disease.Pdf].

Manufacturer Narrative

Csi id#: (b)(4).

Event Description

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.

• Brand Name: DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM
• Type of Device: PERIPHERAL ATHERECTOMY DEVICE
• Manufacturer (Section D): CARDIOVASCULAR SYSTEMS, INC.; 1225 old highway 8 nw; saint paul MN 55112
• MDR Report Key: 9530951
• MDR Text Key: 183111968
• Report Number: 3004742232-2019-00338
• Device Sequence Number: 1
• Product Code: MCW
• Combination Product (y/n): N
• PMA/PMN Number: K190634
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,litera
• Type of Report: Initial,Followup,Followup
• Report Date: 01/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention