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

Model Number DBEC-125

Device Problem Unintended System Motion (1430)

Patient Problems Cardiopulmonary Arrest (1765); Death (1802); Perforation of Vessels (2135); Vascular System (Circulation), Impaired (2572)

Event Date 02/17/2020

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.Patient age: best estimate of age.(b)(4).

Event Description

A diamondback coronary orbital atherectomy device (oad) was used in a coronary procedure for treatment of a 90% stenosed, severely calcified ostial lesion in the right coronary artery (rca).The rca was 3.0-3.25mm in diameter.The lesion was crossed with a non-csi guide wire.Several attempts were made to exchange the guide wire for a csi guide wire, and the exchange was eventually successful.The oad was advanced to the lesion.The device briefly stopped spinning when the device was initially turned on.The oad started successfully on the second attempt, and three (3) short, 7-10 second, treatment passes were performed.It was noted that the crown of the oad had jumped.The patient then experienced chest pain and tightness.The oad was removed, contrast was observed outside of the vessel, and a massive perforation was observed.The patient declined rapidly, coded, and was intubated as an attempt was made to place a covered stent.Six to eight rounds of cpr were administered, the patient began to recover, and pericardiocentesis was performed.Imaging was performed, and the rca had shut down with only a few branches remaining.The patient appeared stable, and was transferred to the cardiovascular intensive care unit.The patient expired overnight on (b)(6) 2020, and the cause of death was reported to have been the perforation.It was noted that the patient had initially been turned down for surgery due to a porcelain aorta, and the left anterior descending coronary artery was severely diseased while the circumflex artery had mildly profuse disease.

• 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: 9807303
• MDR Text Key: 182616107
• Report Number: 3004742232-2020-00066
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 10852528005787
• UDI-Public: (01)10852528005787(17)211231(10)303561
• 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: 03/09/2020

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: 12/31/2021
• Device Model Number: DBEC-125
• Device Catalogue Number: 70058-13
• Device Lot Number: 303561
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/17/2020
• Initial Date FDA Received: 03/09/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/16/2019
• 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: 70 YR