MAUDE Adverse Event Report: CARDIOVASCULAR SYSTEMS, INC. (ABBOTT) 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); Diminished Pulse Pressure (2606); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 12/15/2023

Event Type  Death  

Manufacturer Narrative

The device history record for the reported oad could not be reviewed as the lot number was not provided.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.H6 health effect - clinical code 4581: appropriate term / code not available: abrupt vessel closure, no reflow h6 investigation conclusion code 22: the diamondback 360 coronary orbital atherectomy system instructions for user manual states that abrupt vessel closure, no reflow, cardiac arrest, and death are potential adverse events that may occur and/or require intervention with use of the system.Csi id: (b)(6).

Event Description

A diamondback 360 coronary orbital atherectomy device (oad) was successfully used to treat a severely calcified lesion in the right coronary artery (rca).Stent placement was performed.Following treatment of the left anterior descending (lad) artery and two drug-eluting stent placements, angiographic imaging revealed the vessel shut down.The patient experienced no reflow, hemodynamic collapse, and pulseless electrical activity (pea) arrest.The patient was placed on extracorporeal membrane oxygenation (ecmo) and heart pump.Later in the evening the patient expired.In the opinion of the physician, the csi device caused or contributed to the vessel shutting down and patient's expiration.

• Brand Name: DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM
• Type of Device: CORONARY ATHERECTOMY DEVICE
• Manufacturer (Section D): CARDIOVASCULAR SYSTEMS, INC. (ABBOTT); 1225 old hwy 8 nw; st. paul MN 55112
• Manufacturer (Section G): CARDIOVASCULAR SYSTEMS, INC. (ABBOTT); 1225 old hwy 8 nw; st. paul MN 55112
• Manufacturer Contact: lalaine oria ; 1225 old hwy 8 nw; st. paul, MN 55112
• MDR Report Key: 18477726
• MDR Text Key: 332458986
• Report Number: 3004742232-2024-00073
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/09/2024

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: 12/18/2023
• Initial Date FDA Received: 01/09/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Required Intervention; Hospitalization; Death
• Patient Age: 87 YR
• Patient Sex: Male