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

Model Number DBEC-125

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

Patient Problems Myocardial Infarction (1969); Embolism/Embolus (4438); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 07/03/2019

Event Type  Injury  

Manufacturer Narrative

Csi contacted the corresponding author of the article and requested lot numbers.Csi also requested information regarding possible return of any of the devices.No response was received from the corresponding author.If the devices do become available, they will be analyzed.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 the reported oad could not be reviewed, as the lot number was not provided.If the lot number is provided, a dhr review will be performed.The average patient age was 72.4 years plus or minus 9.2 years.Date of article is 23 september 2020; however, csi is aware that the events occurred on or before (b)(6) 2019.Vessel spasm and abrupt closure.Known inherent risk of device: the diamondback 360® coronary orbital atherectomy system instructions for use manual states that embolization, spasm/abrupt closure, and myocardial infarction are potential adverse events that may occur with use of the system.Date received by manufacturer - due to an inadvertent delay in notification of the events within the article to postmarket surveillance, the mdr was not sent within 30 days of a csi employee becoming aware.Additional training was provided regarding csi's procedures for reporting complaints to postmarket surveillance.Rao, l.G., rao, a.M., rao, s.P., rao, r., bhavsar, j.H., liu, w.Y., igyarto, z., martinsen, b.J.(2020, september 23).Outcomes after coronary orbital atherectomy at centers without on-site surgical backup: diabetics versus non-diabetics and impact of access site.Cardiovascular revascularization medicine.Https://doi.Org/10.1016/j.Carrev.2020.09.029.Csi id# (b)(4).

Event Description

Rao et al.2020 - a literature article was published on 23 september 2020 which indicated the following: during procedures in which csi coronary orbital atherectomy devices (oads) may have been used, there were 1 occurrence of embolization, 2 occurrences of spasm/abrupt closure, and 1 occurrence of myocardial infarction.

• Brand Name: DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM
• Type of Device: CORONARY ATHERECTOMY DEVICE
• Manufacturer (Section D): CARDIOVASCULAR SYSTEMS, INC.; 1225 old highway 8 nw; saint paul MN 55112
• Manufacturer (Section G): CARDIOVASCULAR SYSTEMS, INC.; 1225 old highway 8 nw; saint paul MN 55112
• Manufacturer Contact: sarah hicks ; 1225 old highway 8 nw; saint paul, MN 55112
• MDR Report Key: 11932809
• MDR Text Key: 262656260
• Report Number: 3004742232-2021-00200
• Device Sequence Number: 1
• Product Code: MCX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P130005
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,litera
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: DBEC-125
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/03/2019
• Initial Date FDA Received: 06/03/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 72 YR