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

Model Number DBEC-125

Device Problem Entrapment of Device (1212)

Patient Problems Death (1802); Hematoma (1884); Perforation of Vessels (2135); Vascular System (Circulation), Impaired (2572); Vascular Dissection (3160)

Event Date 07/16/2020

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 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.Csi requested additional information from the facility, but the information has not been received.If additional information is received in the future, a follow-up report will be sent.Csi id: (b)(4).

Event Description

A diamondback coronary orbital atherectomy device (oad) and viperwire guide wire were selected for treatment of a lesion in the circumflex artery.Ten atherectomy treatments were administered.The oad could not be pulled back when removal was attempted.The user realized the brake was down.After the brake was lifted, removal was attempted again, but the oad still did not move.Fluoroscopy was performed, and the oad crown could be seen in the mid to distal circumflex artery.The physician was advised to use glideassist to aid in removal of the device.However, the device was instead turned on at therapeutic speed.The oad immediately retracted into the guide catheter.The oad was turned off and pulled the rest of the way out of the patient.Angiography was performed, and no flow was observed.The lack of flow was due to a perforation in the left main artery.Two covered stents were placed in the circumflex and distal left main.These did not resolve the perforation or lack of flow.Medications were administered in an attempt to stabilize the patient.Due to lack of surgical support on site, the patient was transferred via ambulance to another hospital.The patient coded in the emergency department and subsequently expired.The primary cause of death was spiral dissection and perforation of the left main artery and aorta, as well as posterior hematoma in the myocardium.

• Brand Name: DIAMONDBACK CORONARY ORBITAL ATHERECTOMY SYSTEM
• Type of Device: CORONARY ATHERECTOMY DEVICE
• Manufacturer (Section D): CARDIOVASCULAR SYSTEMS, INC.; 1225 old hwy 8 nw; st. paul, mn
• Manufacturer (Section G): CARDIOVASCULAR SYSTEMS, INC.; 1225 old hwy 8 nw; st. paul, mn
• Manufacturer Contact: morgan hill ; 1225 old hwy 8 nw; st. paul, mn
• MDR Report Key: 10363548
• MDR Text Key: 201581504
• Report Number: 3004742232-2020-00228
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 10852528005787
• UDI-Public: (01)10852528005787(17)220131(10)307323
• 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: 08/04/2020

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2022
• Device Model Number: DBEC-125
• Device Catalogue Number: 70058-13
• Device Lot Number: 307323
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/16/2020
• Initial Date FDA Received: 08/04/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/17/2020
• 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; Required Intervention
• Patient Age: 74 YR