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

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

Patient Problems Myocardial Infarction (1969); Obstruction/Occlusion (2422); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 01/01/2023

Event Type  Injury  

Manufacturer Narrative

A3: reflects majority of patients.B3: date of publication, year valid.H6 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.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).

Event Description

A literature article discussing treatments with diamondback 360 coronary orbital atherectomy device (oad) found angiographic success achieved in 98.7% of cases.Additional treatment was needed after orbital atherectomy with a non-csi device in 6.7% of lesions.There were three periprocedural myocardial infarctions observed.Harding et al."initial experience with orbital atherectomy in australia and new zealand".

Event Description

Additional information was received indicating all treatments in this study were performed on low-speed and 53.3% were performed with high speed tratments.A 65 year old female presented with stable angina.Orbital atherectomy was performed, along with stenting to the left anterior descending artery (lad).Periprocedureal non-st elevation myocardial infarction (nstemi) was observed.Small diagonal vessel was occluded following stenting.The patient was in stable condition.A 75 year old female underwent an orbital atherectomy treatment of the right coronary artery (rca).The patient experienced a signfiicant enzyme rise indication was periprocedural nstemi.The patient was discharged the next day in stable condition.A 77 year old female underwent an orbital atherectomy treatment of the rca, with stenting.The patient had transient no reflow post orbital atherectomy, and slow flow at the end of the procedure.The patient experienced periprocedural nstemi.A 77 year old female underwent orbital atherectomy of the lad with stenting.The patient experienced periprocedural nstemi.A 83 year old male presented with nstemi.The lad was treated with orbital atherectomy and stenting.The patient experienced periprocedural nstemi.

Manufacturer Narrative

Updated fields: b4, b5, g3, g6, h2.H6 health effect - clinical code 4581: slow/no flow.Csi id: (b)(4).

• Brand Name: DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM
• Type of Device: CORONARY ATHERECTOMY DEVICE
• Manufacturer (Section D): CARDIOVASCULAR SYSTEMS, INC.; 1225 old hwy 8 nw; st. paul MN 55112
• Manufacturer (Section G): CARDIOVASCULAR SYSTEMS, INC.; 1225 old hwy 8 nw; st. paul MN 55112
• Manufacturer Contact: aaron stevens ; 1225 old hwy 8 nw; st. paul, MN 55112
• MDR Report Key: 17664510
• MDR Text Key: 322433617
• Report Number: 3004742232-2023-00227
• Device Sequence Number: 1
• Product Code: MCX
• Combination Product (y/n): N
• Reporter Country Code: NZ
• PMA/PMN Number: P130005
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/09/2023

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/01/2023
• Initial Date FDA Received: 08/31/2023
• Supplement Dates Manufacturer Received: 09/17/2023
• Supplement Dates FDA Received: 10/09/2023
• 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 Sex: Male