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 Cardiopulmonary Arrest (1765); Death (1802); Perforation of Vessels (2135)

Event Date 06/14/2019

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 was unable to be reviewed, as the lot number was not provided.Csi id: (b)(4).

Event Description

Following several treatments on low speed in the distal left anterior descending artery (lad) and two treatments on low speed in the proximal lad with the coronary diamondback orbital atherectomy device (oad), high speed was selected for a final treatment, and a perforation occurred.The patient became hypotensive and coded.The patient was intubated, had chest compressions performed and was given life saving drugs.While the patient was given cardiopulmonary resuscitation, drugs and ventilation, the physician placed an impella device.The patient went into ventricular fibrillation and was given cardioversion, along with chest compressions and advanced cardiac life support (acls) protocols.The physician re-wired the vessel and place a stent over the perforation.A transesophageal electrocardiograph was performed and revealed an effusion, so a second physician performed a pericardiocentesis, which relieved some of the blood built up around the ventricle.There was no cardiac activity for one hour and twenty minutes, and time of death was called.The opinion of the physician was that the primary cause of death was the perforation, along with severe calcium and the progression of the patient's coronary artery disease.The target lesion was severely calcified and 90% stenotic, with a diameter of 3-4mm.

• 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: brittany leider ; 1225 old highway 8 nw; saint paul, MN 55112 ; 6512591600
• MDR Report Key: 8781735
• MDR Text Key: 150737257
• Report Number: 3004742232-2019-00176
• 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: 07/11/2019

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: 06/14/2019
• Initial Date FDA Received: 07/11/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• 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: 62 YR
• Patient Weight: 51