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 Chest Pain (1776); Low Blood Pressure/ Hypotension (1914); Myocardial Infarction (1969); Aortic Dissection (2491); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 07/10/2018

Event Type  Injury  

Manufacturer Narrative

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 was unable to be reviewed, as the lot number was not provided.(b)(4).

Event Description

During a coronary atherectomy procedure using a csi orbital atherectomy device, a dissection occurred.It was reported that a type f dissection occurred following atherectomy treatment.Balloon angioplasty was performed and three stents were placed to resolve the dissection.Following the procedure, the patient presented with chest pain and hypotension.An ekg was performed and an st elevated myocardial infarction was diagnosed.The troponin levels of the patient were also elevated.A heart catheterization was performed to confirm the stent placement and the patient was placed on bipap therapy.Following hospitalization, the patient was discharged in stable condition.

Event Description

Additional information received indicated the clinical event committee reviewed images and concluded that the use of the diamondback 360 coronary orbital atherectomy device may have contributed to an abrupt vessel closure and slow/no flow.

Manufacturer Narrative

H6 investigation conclusion code 22: the diamondback 360® coronary orbital atherectomy system instructions for use manual states that slow flow or no reflow phenomenon and abrupt vessel closure potential adverse events that may occur and/or require intervention with use of the system.H6 health effect - clinical code 4581: slow/no flow and abrupt closure.The device history record for this oad lot number has been reviewed.No issues or discrepancies were noted during this review that would have contributed to the reported event.The device met material, assembly, and quality control requirements.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).

• 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: laramie otto ; 1225 old highway 8 nw; saint paul, MN 55112
• MDR Report Key: 7759440
• MDR Text Key: 116313724
• Report Number: 3004742232-2018-00240
• 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: Study,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/12/2024

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: 07/10/2018
• Initial Date FDA Received: 08/07/2018
• Supplement Dates Manufacturer Received: 12/04/2023
• Supplement Dates FDA Received: 01/12/2024
• 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): Life Threatening; Hospitalization; Required Intervention
• Patient Age: 65 YR