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

Model Number C-2DB-CL125-135

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Chest Pain (1776); Low Blood Pressure/ Hypotension (1914); Myocardial Infarction (1969); Vascular Dissection (3160); Thrombosis/Thrombus (4440); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 11/24/2023

Event Type  Injury  

Event Description

A diamondback 360 coronary orbital atherectomy device (oad) was used to treat a proximal 80-90% stenosed left anterior descending artery (lad).The physician experienced difficulty wiring to begin the procedure, but they were eventually able to wire with a non-csi wire, then replaced to a viperwire advance guide wire.After two treatments of 30 seconds with the oad, slow flow was observed.A third treatment was performed for 25 seconds, and the patient experienced ischemic electrocardiogram (ecg) changes, reduced cardiac output, and chest pain.A balloon was used, and there was no reflow to the proximal lad.Intravascular ultrasound (ivus) showed a dissection and thrombus.An aspiration catheter was used, and tirofiban was administered.Two stents were placed and post dilation with a balloon was performed.Final angiographic imaging showed timi ii flow.The patient was monitored overnight, and still was experiencing residual chest pain and had low blood pressure but was in stable condition.

Manufacturer Narrative

H6 health effect - clinical code 4581: slow/no flow.H6 investigation conclusion code 22: the diamondback 360® coronary orbital atherectomy system instructions for use manual states that vascular dissection, myocardial infarction, slow or no reflow phenomenon, and thrombus are potential adverse events that may occur and/or require intervention with use of the system.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.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: aaron stevens ; 1225 old hwy 8 nw; st. paul, MN 55112
• MDR Report Key: 18328088
• MDR Text Key: 330509395
• Report Number: 3004742232-2023-00299
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 10850000491417
• UDI-Public: (01)10850000491417(17)240630(10)439895-1
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: 12/14/2023

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: 439895-1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/29/2023
• Initial Date FDA Received: 12/14/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/28/2022
• 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): Required Intervention; Hospitalization
• Patient Age: 83 YR
• Patient Sex: Female
• Patient Weight: 56 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White