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

Model Number	RAD-SC30-175
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	08/15/2019
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.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 prior to distribution.The stealth peripheral orbital atherectomy system instructions for use manual states that dissection is a potential adverse event that may occur and/or require intervention.(b)(4).
Event or Problem Description
The target lesion was in the superficial femoral artery (sfa) and was 100% stenosed.Six treatment passes were performed with a peripheral stealth radial orbital atherectomy device (oad) on medium and high speeds.Balloon angioplasty dilatation was then performed, however significant residual stenosis remained.A shorter balloon at high pressure was then used to perform dilatation in the mid sfa, following which a type c dissection was noted.The balloon was inflated in place and access was gained to the posterior tibial artery.A sheath was inserted and a stent was delivered.The balloon was then used to dilate the stent.The final angiogram showed excellent flow and the patient was discharged the same day.
Additional Manufacturer Narrative
Per the opinion of the treating physician, the reported dissection was caused by the balloon dilatation and no csi device caused or contributed to the event.Based on this information, this no longer meets the definition of a csi reportable event.(b)(4).

• Brand Name: STEALTH PERIPHERAL ORBITAL ATHERECTOMY SYSTEM
• Common Device Name: PERIPHERAL ATHERECTOMY DEVICE
• Manufacturer (Section D): CARDIOVASCULAR SYSTEMS, INC.; 1225 old highway 8 nw; st. paul, mn MN 55112
• MDR Report Key: 9416286
• Report Number: 3004742232-2019-00318
• Device Sequence Number: 16756865
• Product Code: MCW
• UDI-Device Identifier: 10852528005770
• UDI-Public: (01)10852528005770(17)210430(10)265339
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K133399
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,study,use
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/16/2019

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: 04/30/2021
• Device Model Number: RAD-SC30-175
• Device Catalogue Number: 7-10058-03
• Device Lot Number: 265339
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/05/2019
• Supplement Date Received by Manufacturer: 12/10/2019
• Initial Report FDA Received Date: 12/05/2019
• Supplement Report FDA Received Date: 12/16/2019
• 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: 45 YR
• Patient Weight: 91