MAUDE Adverse Event Report: SILK ROAD MEDICAL ENROUTE TRANSCAROTID NEUROPROTECTION SYSTEM; ENROUTE NPS

Model Number	SR-200-NPS
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Patient Problem/Medical Problem (2688); Vascular Dissection (3160)
Date of Event	06/28/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
A dissection was noted on the second angiogram that confirmed tip placement distal to the arterial sheath tip.The dissection most likely occured during 0.035" wire and srm arterial sheath introduction to the cca (common carotid artery).The dissection was a non-flow limiting dissection.The target lesion was treated successfully.The dissection was treated with an 8x20 balloon inflation and an 8x30 enroute transcarotid stent.Patient was awake post procedure and there were no neurological symptoms.

• Brand Name: ENROUTE TRANSCAROTID NEUROPROTECTION SYSTEM
• Common Device Name: ENROUTE NPS
• Manufacturer (Section D): SILK ROAD MEDICAL; 735 north pastoria avenue; sunnyvale CA 94085
• MDR Report Key: 5815660
• Report Number: 3007215228-2016-00002
• Device Sequence Number: 1164357
• Product Code: NTE
• UDI-Device Identifier: 00811311020744
• UDI-Public: (01)00811311020744(17)161027(10)200541
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K153485
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/14/2016

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: 10/27/2016
• Device Model Number: SR-200-NPS
• Device Catalogue Number: SR-200-NPS
• Device Lot Number: 200541
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/28/2016
• Initial Report FDA Received Date: 07/22/2016
• 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
• Patient Age: 76 YR