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

Model Number DBEC-125

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Perforation of Vessels (2135)

Event Date 05/27/2021

Event Type  Death  

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 could not be reviewed, as the lot number was not provided.If the lot number is provided, a dhr review will be performed.(b)(4): the diamondback coronary orbital atherectomy system instructions for use state that the minimum vessel diameter for use with oas is 2.0 mm.The patient's vessel was smaller than 2.0 mm in diameter.Csi id# (b)(4).

Event Description

A diamondback coronary orbital atherectomy device (oad) was selected for treatment of a 90% stenosed, calcified lesion in the mid-left anterior descending coronary artery (lad).The lad was bifurcated.Two treatments on low speed were performed, and a perforation was observed.Pericardiocentesis was performed, and multiple stents were placed; however, a covered stent was unable to be deployed.The patient expired.The cause of death was reported to be due to the perforation of the lad.Upon review of images post procedure, the vessel was determined to have been smaller than 2.0 mm in diameter.

• 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: 12037455
• MDR Text Key: 257358183
• Report Number: 3004742232-2021-00215
• 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: 06/21/2021

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: 05/28/2021
• Initial Date FDA Received: 06/21/2021
• 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): Death
• Patient Age: 53 YR