MAUDE Adverse Event Report: SILK ROAD MEDICAL, INC ENROUTE NEUROPROTECTION SYSTEM; TEMPORARY CAROTID CATHETER FOR EMBOLIC CAPTURE

Model Number SR-200-NPS

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Patient Problem/Medical Problem (2688); Vascular Dissection (3160)

Event Date 02/11/2020

Event Type  Injury  

Manufacturer Narrative

The product in complaint was not returned to the manufacturer for analysis.A review of the manufacturing records for this device was completed and no issues were "identifed" that could have lead to the adverse event reported.Complaints will continue to be monitored for any trends.

Event Description

It was reported that a (b)(6) year old male underwent a right transcarotid revascularization procedure on (b)(6) 2020.There were no complications with access.However, after several attempts to cross the critical lesion, it was discovered that the wire was in a sub-intimal dissection plane.The dissection plane began at the level of the most proximal portion of the stenosis and continued shortly beyond the lesion distally.At this point, the tcar was aborted and the physician decided to convert to a carotid endarterectomy (cea).The patient had a successful cea and was discharged the following day without any events.No additional details were provided.

• Brand Name: ENROUTE NEUROPROTECTION SYSTEM
• Type of Device: TEMPORARY CAROTID CATHETER FOR EMBOLIC CAPTURE
• Manufacturer (Section D): SILK ROAD MEDICAL, INC; 1213 innsbruck drive; sunnyvale, ca
• Manufacturer (Section G): SILK ROAD MEDICAL, INC; 1213 innsbruck drive; sunnyvale, ca
• Manufacturer Contact: 1213 innsbruck drive; sunnyvale, ca
• MDR Report Key: 9751064
• MDR Text Key: 189081633
• Report Number: 3014526664-2020-00042
• Device Sequence Number: 1
• Product Code: NTE
• UDI-Device Identifier: 00811311020829
• UDI-Public: (01)00811311020829(17)220618(10)300818
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K153485
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: SR-200-NPS
• Device Catalogue Number: SR-200-NPS
• Device Lot Number: 300818
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/11/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 73 YR