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

Model Number	PRD-SC30-200
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	08/07/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information: the physician attributed the dissection to the patient's disease state and anatomy, but it is unclear whether the oad contributed to the dissection.Device analysis conclusion: the oad was returned to csi for analysis.Visual examination did not reveal any damage that would have contributed to the reported dissection.The oad operated as intended during functional testing.The device data was downloaded and analyzed.The data did not reveal any stall condition during the procedure.As the guide wire was not returned, it could not be determined if it had contributed to the reported complaint.At the conclusion of the device analysis investigation, the reported stall could not be confirmed.The root cause of the dissection also could not be confirmed through analysis.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.Csi id: (b)(4).
Event or Problem Description
A stealth pluto orbital atherectomy device (oad) was selected for treatment of a heavily calcified common femoral stenosis with ostial superficial femoral artery chronic total occlusion via left common femoral antegrade access.Following several treatments in the proximal lesion and one distal treatment, the oad stalled.When tested ex vivo, the device operated as intended.During the second attempt at distal treatment, the issue recurred.A dissection was noted on angiogram after the oad was removed from the patient and after angiography had been performed.The dissection flap occluded the vessel.A stent was placed, and the dissection was resolved.The procedure concluded with angioplasty and stent placement with no further indication of dissection or perforation.

• Brand Name: STEALTH ORBITAL ATHERECTOMY SYSTEM
• Common Device Name: PERIPHERAL ORBITAL ATHERECTOMY DEVICE
• Manufacturer (Section D): CARDIOVASCULAR SYSTEMS, INC.; 1225 old hwy 8 nw; st. paul MN 55112
• MDR Report Key: 10502605
• Report Number: 3004742232-2020-00272
• Device Sequence Number: 19628669
• Product Code: MCW
• UDI-Device Identifier: 10850000491295
• UDI-Public: (01)10850000491295(17)220331(10)316502
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/08/2020

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: 03/31/2022
• Device Model Number: PRD-SC30-200
• Device Catalogue Number: 7-10059-04
• Device Lot Number: 316502
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/11/2020
• Initial Report FDA Received Date: 09/08/2020
• 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
• Patient Age: 78 YR
• Patient Weight: 78