MAUDE Adverse Event Report: CARDIOVASCULAR SYSTEMS INCORPORATED STEALTH 360 PERIPHERAL 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 Code	Vascular Dissection (3160)
Date of Event	05/02/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was discarded by the facility; therefore, an analysis of the actual complaint device is not possible.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.(b)(4).
Event or Problem Description
It was reported that during a peripheral orbital atherectomy procedure, a dissection occurred while using a csi orbital atherectomy device (oad).The target lesion was 20mm in length and was located in the superficial femoral artery (sfa).The physician accessed the lesion using a 6fr introducer sheath and a csi viperwire guide wire.The oad was loaded onto the guide wire and the physician performed multiple runs at low, medium and high speed.The oad was removed and atherectomy was followed-up with balloon angioplasty.Post-angioplasty angiography revealed a spiral dissection in the sfa.The physician deployed a covered stent and resolved the dissection.The patient status remained stable throughout the procedure.A request was made for additional information, but was denied by the facility due to internal policies.

• Brand Name: STEALTH 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM
• Common Device Name: PERIPHERAL ATHERECTOMY DEVICE
• Manufacturer (Section D): CARDIOVASCULAR SYSTEMS INCORPORATED; 1225 old highway 8 nw; saint paul MN 55112
• MDR Report Key: 5666325
• Report Number: 3004742232-2016-00048
• Device Sequence Number: 16256391
• Product Code: MCW
• UDI-Device Identifier: 10852528005053
• UDI-Public: (01)10852528005053(17)181130(10)148145
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K110389
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/18/2016

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: Physician
• Device Expiration Date: 11/30/2018
• Device Model Number: PRD-SC30-200
• Device Catalogue Number: PRD-SC30-200
• Device Lot Number: 148145
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/02/2016
• Initial Report FDA Received Date: 05/19/2016
• 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