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 High Blood Pressure/ Hypertension (1908); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 09/27/2021

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.Follow-up attempts to obtain additional information were made, but the hospital declined to provide additional information.In the opinion of the physician, slow flow could have been caused by a number of different factors (including atherectomy) however, the exact cause remains unknown.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 diamondback coronary orbital atherectomy system instructions for use states that slow flow (and hypertension?) is a potential adverse event that may cause and/or require intervention.Date of event is approximate since the event was reported to csi staff in a presentation.The date listed is the date of the presentation.(b)(4).

Event Description

Following orbital atherectomy treatment to the left anterior descending artery (lad), a catheter was inserted and advanced to the distal lad.The patient experienced an increase in pulmonary artery pressure, likely due to slow flow observed in a diagonal branch.The vessel was re-wired and balloon angioplasty was performed to restore flow.Additional balloon angioplasty and stent placement was performed to complete the procedure, with a good timi flow result.Due to the high pulmonary artery pressure the impella device was left in overnight.The patient recovered well.

• 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: brittany leider ; 1225 old highway 8 nw; saint paul, MN 55112 ; 6512591600
• MDR Report Key: 12697474
• MDR Text Key: 278360054
• Report Number: 3004742232-2021-00356
• 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,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/26/2021

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: 09/27/2021
• Initial Date FDA Received: 10/26/2021
• 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): Required Intervention