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); Death (1802); Dyspnea (1816); Perforation of Vessels (2135)

Event Date 06/25/2020

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 id: (b)(4).

Event Description

A diamondback coronary orbital atherectomy device was selected for treatment of a non-tortuous but severely calcified lesion in the left anterior descending artery (lad).The lesion was 95%-98% stenosed, 10-12mm in length with a vessel diameter of 3.75.The oad was operated for three to four treatment passes at low speed without issue.The patient complained of shortness of breath and minor chest pain.The oad was removed, and imaging was performed.A significant vessel perforation was identified just distal to the lesion.The physician and consulting surgeon remarked that the size of the perforation was larger than they had experienced.A pericardial effusion occurred.A balloon was advanced and inflated to ensure that the vessel was sealed.The patient was intubated and sent to the operating room (or).The balloon, wire, guide catheter and sheath remained in vivo, to maintain homeostasis, and prevent a bleed out.The devices were later removed in surgery.After five hours the distal lad could not be located, and the proximal lad was tied off.After two additional hours in the or, significant blood loss caused the surgeon to stop the procedure.The patient remained stable.The following day, an echocardiogram showed that the anterior wall lacked motion; however, the opinion of the physician was that the patient would remain stable.The patient passed away a few days later on (b)(6) 2020.

• 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: brittany leider ; 1225 old highway 8 nw; saint paul, mn ; 2591600
• MDR Report Key: 10314004
• MDR Text Key: 200053279
• Report Number: 3004742232-2020-00206
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 10850000491356
• UDI-Public: (01)10850000491356(17)220331(10)317308
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K190634
• 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: 07/23/2020

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: 03/31/2022
• Device Model Number: DBEC-125
• Device Catalogue Number: 7-10060-01
• Device Lot Number: 317308
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/25/2020
• Initial Date FDA Received: 07/23/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/10/2020
• 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
• Patient Age: 77 YR