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

Model Number	PRD-SC30-200
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Aneurysm (1708); Rupture (2208)
Date of Event	09/11/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.(b)(4).
Event or Problem Description
Orbital atherectomy(oa) followed by balloon angioplasty was successfully completed in a calcified superficial femoral artery.Oa treatment was continued in a calcified profunda artery.On the third treatment pass on high speed the stealth peripheral orbital atherectomy device (oad) stopped spinning and the crown was angled outside of the vessel.An angiogram was performed and revealed a vessel rupture had occurred during treatment and that an aneurysm was present near the crown of the oad.The oad and viperwire guide wire were removed.Coiling was performed to resolve the aneurysm.The remaining vessels of the profunda artery were intact, with no other complications observed.The patient condition was reported as fine.Per the opinion of the physician, the csi device contributed to the aneurysm event.The cause of the vessel rupture was unknown.

• Brand Name: STEALTH ORBITAL ATHERECTOMY SYSTEM
• Common Device Name: PERIPHERAL ATHERECTOMY DEVICE
• Manufacturer (Section D): CARDIOVASCULAR SYSTEMS, INC.; 1225 old highway 8 nw; saint paul MN 55112
• MDR Report Key: 10648121
• Report Number: 3004742232-2020-00303
• Device Sequence Number: 19734210
• Product Code: MCW
• UDI-Device Identifier: 10850000491295
• UDI-Public: (01)10850000491295(17)220131(10)308598
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/08/2020

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: 01/31/2022
• Device Model Number: PRD-SC30-200
• Device Catalogue Number: 7-10059-04
• Device Lot Number: 308598
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/11/2020
• Initial Report FDA Received Date: 10/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention