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

Model Number PRD-SC30-MICRO

Device Problem Contamination (1120)

Patient Problems Perforation of Vessels (2135); Vascular Dissection (3160)

Event Date 02/01/2023

Event Type  Injury  

Manufacturer Narrative

Return of the device for analysis is anticipated.A supplemental report will be submitted when the investigation is complete.Csi id: (b)(4).

Event Description

A diamondback 360 peripheral orbital atherectomy device (oad) was used to treat a lesion in the right anterior tibial artery.A low-speed treatment was performed and at approximately 10cm of the axial crown travel, there was an unusual noise and treatment was stopped.The physician attempted to re-start treatment and applied glideassist, however, they were unable to advance.The physician believed the viperwire advance guide wire was the issue.The physician removed the viperwire and observed a small bend, which led to a replacement of the viperwire.Another low-speed treatment was performed and at the same location as the first treatment, another unusual noise was heard.The physician had difficulty removing the oad.Glideassist was utilized to assist in removal of the oad.The physician observed a small fiber of unknown material around the distal tip of the oad.The oad was replaced with a new oad.A low-speed treatment was performed and at the same location as the first two treatments, an unusual noise was heard.At the end of the atherectomy procedure, angiography showed blood extravasation on the beginning of the distal third portion of the right anterior tibial artery.The physician completed the procedure with balloon angioplasty.The patient was in stable condition.

Manufacturer Narrative

Updated fields: b4, b5, b9, g3, g6, h2, h3, h6.H6: additional information received indicated the extravasation was due to dissection, and not perforation.In addition, the device is not anticipated to be returned.H6 investigation conclusion code 22: the diamondback 360® coronary orbital atherectomy system instructions for use manual states that vascular dissection 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.

Event Description

Additional information was received indicating the physician believed the extravasation was due to a dissection caused by the oad.

• Brand Name: STEALTH 360 ORBITAL ATHERECTOMY SYSTEM
• Type of Device: 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: 16526013
• MDR Text Key: 311127024
• Report Number: 3004742232-2023-00065
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 10850026568261
• UDI-Public: (01)10850026568261(17)240831(10)445303-3
• Combination Product (y/n): N
• Reporter Country Code: CI
• PMA/PMN Number: K190634
• 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,Followup
• Report Date: 04/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PRD-SC30-MICRO
• Device Catalogue Number: 7-10059-49
• Device Lot Number: 445303-3
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/21/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/03/2022
• 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
• Patient Age: 66 YR
• Patient Sex: Male
• Patient Weight: 90 KG