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

Model Number DBEC-125

Device Problem Mechanical Problem (1384)

Patient Problems Cardiopulmonary Arrest (1765); Death (1802); Ischemia (1942); Perforation of Vessels (2135)

Event Date 07/22/2020

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.The diamondback 360coronary orbital atherectomy device instructions for use states that perforation and death are a possible adverse events which can occur with use of the diamondback 360coronary orbital atherectomy device.Csi id# (b)(4).

Event Description

A diamondback coronary orbital atherectomy device (oad) was selected for a high risk case that included treatment of a lesion in the left main and proximal left anterior descending (lad) coronary arteries.The vessels were 3.0 to 4.0 mm in diameter with minimal tortuosity.After the fourth treatment, the device stopped spinning, and a perforation was observed in the lad.A drug eluting stent was placed to stop the bleeding, but it was not successful.The perforation was then treated with a covered stent, which was also unsuccessful.The left circumflex artery was jailed with a second covered stent to resolve the perforation.The patient's right coronary artery was a cto that had been fed by the left circumflex.As the left circumflex was jailed with the covered stent, the left circumflex and right coronary artery no longer had blood flow.The patient coded, and cpr was administered.The patient expired.The opinion of the physician was that the death was caused by ischemia.

• 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
• Manufacturer (Section G): CARDIOVASCULAR SYSTEMS, INC.; 1225 old highway 8 nw; saint paul, mn
• Manufacturer Contact: sarah hicks ; 1225 old highway 8 nw; saint paul, mn
• MDR Report Key: 10410643
• MDR Text Key: 203032951
• Report Number: 3004742232-2020-00242
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 10852528005787
• UDI-Public: (01)10852528005787(17)220228(10)312155
• 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: 08/14/2020

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2022
• Device Model Number: DBEC-125
• Device Catalogue Number: 70058-13
• Device Lot Number: 312155
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/22/2020
• Initial Date FDA Received: 08/14/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/13/2020
• 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: 96 YR
• Patient Weight: 68