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 Cardiac Arrest (1762); Cardiac Enzyme Elevation (1838); Low Blood Pressure/ Hypotension (1914); Embolism/Embolus (4438); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 05/10/2022

Event Type  Death  

Event Description

Radial access was obtained, and a non-csi, 6fr guide wire was placed.Three to four low speed atherectomy treatments were performed in the patient's right coronary artery (rca) with a diamondback 360 coronary orbital atherectomy device (oad).The lesion was large, and the vessel was diffusely diseased.St elevation was observed via an electrocardiogram (ecg), and slow flow was identified via angiogram.The patient went into cardiac arrest and cardiopulmonary resuscitation was performed.Adenosine, nitrates, and vasopressors (adrenaline, noradrenaline) were administered.The patient was successfully defibrillated, and the oad was removed.Significant st elevation remained, and the patient's blood pressure was very low.The patient was intubated, the vessel was rewired, balloon angioplasty was performed, and stent placement was completed.Blood flow returned to the vessel with systolic pressure at 120, and the procedure was completed.The patient was transferred to the intensive care unit and later expired.In the opinion of the physician, the cause of the adverse event was embolization leading to a blockage of the distal vessel, the primary cause of death was acute myocardial infarction, coronary intervention procedure, and end stage renal disease, and the secondary cause of death was a recent myocardial infarction.

Manufacturer Narrative

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 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.(b)(4).Csi id: (b)(4).

• Brand Name: DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM
• Type of Device: CORONARY ATHERECTOMY DEVICE
• Manufacturer (Section D): CARDIOVASCULAR SYSTEMS, INC.; 1225 old hwy 8 nw; st. paul MN 55112
• Manufacturer (Section G): CARDIOVASCULAR SYSTEMS, INC.; 1225 old hwy 8 nw; st. paul MN 55112
• Manufacturer Contact: kim mcclure ; 1225 old hwy 8 nw; st. paul, MN 55112 ; 6519006741
• MDR Report Key: 14634447
• MDR Text Key: 293569759
• Report Number: 3004742232-2022-00134
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 10850000491417
• UDI-Public: (01)10850000491417(17)240228(10)420504-1
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P130005
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/08/2022

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: 02/28/2024
• Device Model Number: DBEC-125
• Device Lot Number: 420504-1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/10/2022
• Initial Date FDA Received: 06/08/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/03/2022
• 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): Other; Death
• Patient Sex: Male