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

Model Number	PRD-MAX-200
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Embolism/Embolus (4438)
Date of Event	03/20/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation conclusion code 22: the stealth 360® peripheral orbital atherectomy system instructions for use manual states that vessel occlusion is a potential adverse event 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).
Event or Problem Description
A stealth 360 peripheral orbital atherectomy device (oad) was used to treat a mid-superficial femoral artery (sfa) of a 5 cm mixed morphology lesion.There was a three-vessel runoff, all of which had embolisms, and two vessels were occluded.Tissue plasminogen activator (tpa), nitroglycerin, and manual aspiration were used to resolve the event.

• Brand Name: STEALTH 360 ORBITAL ATHERECTOMY SYSTEM
• Common Device Name: PERIPHERAL 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: 16707619
• Report Number: 3004742232-2023-00097
• Device Sequence Number: 3614513
• Product Code: MCW
• UDI-Device Identifier: 10850026568711
• UDI-Public: (01)10850026568711(17)241231(10)467070-1
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K190634
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/10/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2024
• Device Model Number: PRD-MAX-200
• Device Catalogue Number: 7-10059-46
• Device Lot Number: 467070-1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/20/2023
• Initial Report FDA Received Date: 04/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/20/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown