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

Model Number C-2DB-CL125-135

Device Problems Unintended System Motion (1430); Material Separation (1562)

Patient Problems Perforation of Vessels (2135); Foreign Body In Patient (2687); Pericardial Effusion (3271)

Event Date 12/13/2023

Event Type  Death  

Manufacturer Narrative

H6 investigation conclusion code 22: the diamondback 360® coronary orbital atherectomy system instructions for user manual states that a perforation of vessels is a potential adverse event that may occur and/or require intervention with use of the system.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

The diamondback 360 coronary orbital atherectomy device (oad) was used for treatment, in a high risk percutaneous coronary intervention of a severely calcified proximal/medial left anterior descending artery (lad).A transradial approach was attempted, but due to poor backup, a transfemoral approach was attempted and successfully utilizing a duplex-guided puncture of the aorto femoral bypass (afc) with non-csi sheath and guide wire.The oad and viperwire advance guide wire were then advanced.Two treatments with the oad were performed on low speed, during the second treatment while spinning antegrade, the oad crown was observed to have jumped distally.A perforation and viperwire fracture were observed.Immediate deterioration on hemodynamics was noted and echocardiographic detected hemorrhagic pericardial effusion.Balloon occlusion was performed in the lad and successful drainage of approximately 200 ml of the hemorrhagic pericardial effusion.After hemodynamic stabilization with administered medication, suparenin, cardiopulmonary resuscitation (cpr) was temporarily interrupted.Contralateral placement of a non-csi sheath in the afc and non-csi guide wire in the proximal lad.Unsuccessful attempt to advance first stent due to poor backup but stent placement of long distance stenting of the distal to proximal lad was successfully performed.Medication of protamine was administered.Cpr was performed for 70 minutes before reanimation measures were discontinued.The patient expired.The opinion of the physician was the oad caused the perforation and contributed to the patient expiring.

• 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: poonoy chanthavongsa ; 1225 old hwy 8 nw; st. paul, MN 55112
• MDR Report Key: 18463454
• MDR Text Key: 332292782
• Report Number: 3004742232-2024-00001
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 10850000491417
• UDI-Public: (01)10850000491417(17)250228(10)474777-1
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 01/08/2024

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: C-2DB-CL125-135
• Device Catalogue Number: 7-10060-03/
• Device Lot Number: 474777-1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/14/2023
• Initial Date FDA Received: 01/08/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/13/2023
• 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
• Treatment: GWC-12325LG-FT.470623-1.
• Patient Outcome(s): Required Intervention; Death