MAUDE Adverse Event Report: CARDIOVASCULAR SYSTEMS INCORPORATED STEALTH 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM; PERIPHERAL ATHERECTOMY DEVICE

Model Number	PRD-SC30-125
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Perforation of Vessels (2135); Vascular Dissection (3160)
Date of Event	05/05/2015
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device analysis: the device was not returned for analysis; 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 identified that during a peripheral orbital atherectomy procedure, a perforation and a type a dissection occurred.The events were identified by a third party vendor, (b)(4).(b)(4) reviewed all procedural angiograms as part of a (b)(4) clinical trial.The target lesion was located in the peroneal artery.The physician used a 5fr introducer sheath to access the lesion.A (b)(4) viperwire was advanced across the lesion and a (b)(4) orbital atherectomy device (oad) was loaded onto it.The physician successfully treated the lesion using the oad and followed-up atherectomy with balloon angioplasty.No complications were noted during the procedure and the patient status remained stable throughout.Follow-up review by (b)(4) identified a perforation and a type a dissection; however, no complications were noted by the treating physician during the procedure.The (b)(4) angiogram evaluation was reviewed by (b)(4) for potential adverse events on (b)(6) 2016.

• 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: 5684792
• Report Number: 3004742232-2016-00069
• Device Sequence Number: 13537366
• Product Code: MCW
• UDI-Device Identifier: 10852528005039
• UDI-Public: (01)10852528005039(17)180331(10)123622
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/23/2016

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: 03/31/2018
• Device Model Number: PRD-SC30-125
• Device Catalogue Number: PRD-SC30-125
• Device Lot Number: 123622
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/29/2016
• Initial Report FDA Received Date: 05/27/2016
• 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: Other
• Patient Age: 75 YR