MAUDE Adverse Event Report: CARDIOVASCULAR SYSTEMS INC. STEALTH 360 ORBITAL ATHERECTOMY SYSTEM; PERIPHERAL ATHERECTOMY DEVICE

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

Patient Problems Arrhythmia (1721); Embolism/Embolus (4438); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 01/10/2024

Event Type  Injury  

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 distal embolization and slow flow or no reflow phenomenon are potential adverse events that may occur and/or require intervention with use of the system.The device history record for the reported oad could not be reviewed as the lot number was not provided.If the lot number is provided, a dhr review will be performed.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).

Event Description

During treatment of a moderately calcified lesion about 150mm in length, in the left superficial femoral artery (sfa) via right common femoral access and left pedal access, the stealth 360 orbital atherectomy device (oad) was spun initially at low speed, medium speed and then high speed.Angioplasty was done and a stent was placed in the sfa.The physician believed that during the procedure, the plaque embolized down to the foot causing slow flow.A non-csi oad was used to treat embolization on the following day ((b)(6)2024).During follow-up ((b)(5)2024), the patient had a strong pulse and warm foot.It was noted that the edema was better.

• Brand Name: STEALTH 360 ORBITAL ATHERECTOMY SYSTEM
• Type of Device: PERIPHERAL ATHERECTOMY DEVICE
• Manufacturer (Section D): CARDIOVASCULAR SYSTEMS INC.; 1225 old highway 8 nw; st. paul MN 55112
• Manufacturer (Section G): CARDIOVASCULAR SYSTEMS INC.; 1225 old highway 8 nw; st. paul
• Manufacturer Contact: keerthi bangalore ramanath ; 1225 old highway 8 nw; st. paul 55112
• MDR Report Key: 18677593
• MDR Text Key: 335024517
• Report Number: 3004742232-2024-00092
• Device Sequence Number: 1
• Product Code: MCW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K190634
• 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: 02/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/16/2024
• Was Device Evaluated by Manufacturer?: No
• 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
• Patient Age: 58 YR
• Patient Sex: Male
• Patient Weight: 78 KG