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	09/16/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device discarded by hospital.
Event or Problem Description
After introduction of the enroute neuroprotection system (nps), it was noted the flushing arm would not aspirate with ease and had some air.It was mentioned as it seemed as if it was on the back wall.Physician retracted the sheath a short distance and the sheath aspirated with ease and was able to flush.On subsequent angiogram, dissection with extravasation noted in the lcca.Sheath was removed and vessel clamped while some care was given to arteriotomy by physician then the sheath replaced.Sheath was aspirated and flushed and angiogram showed better lumen filling with dissection and extravasation.Physician felt we could stent over the flap and procedure continued.Nps connected and flow reversal initiation per routine.Wire placed across lesion.Pre dilation, stent and post dilatation performed.Lumen visualization vastly improved but still some staining.Second stent placed over lapping stent up to the edge of the nps sheath.Angiogram performed.Procedure completed.Drain placed and protamine given.Patient extubated intact.

• Brand Name: ENROUTE TRANSCAROTID NEUROPROTECTION SYSTEM
• Common Device Name: ENROUTE NPS
• Manufacturer (Section D): SILK ROAD MEDICAL; 735 north pastoria; sunnyvale CA 95085
• MDR Report Key: 6001956
• Report Number: 3007215228-2016-00003
• Device Sequence Number: 672925
• Product Code: NTE
• UDI-Device Identifier: 00811311020744
• UDI-Public: (01)00811311020744(17)161213(10)200576
• 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): 10/05/2016

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: 12/13/2016
• Device Model Number: SR-200-NPS
• Device Catalogue Number: SR-200-NPS
• Device Lot Number: 200576
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/16/2016
• Initial Report FDA Received Date: 10/05/2016
• 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: 67 YR