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

Model Number SR-200-NPS

Device Problem Patient Device Interaction Problem (4001)

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

Event Date 10/07/2019

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 identified that could have lead to the adverse event reported.Complaints will continue to be monitored for any trends.

Event Description

It was reported that an (b)(6) year old symptomatic patient underwent a right transcarotid artery revascularization (tcar) procedure on (b)(6) 2019.After obtaining access and placing the enroute arterial sheath, the physician secured the neuro-protection system and checked the flow.Flow was brisk.The physician then proceeded to clamp the vessel using the vessel loop.However, when he checked reverse flow, there was no flow, so the physician released the vessel loop and checked the flow and it was vigorous again.The physician thought that the arterial sheath might have been against the vessel wall.However, the two views that were taken did not indicate that.The physician still attempted to reposition the arterial sheath.The physician clamped again however, there was still no reverse flow.The physician released the vessel loop and decided to use a profunda clamp this time.The physician placed the profunda clamp and checked again and there was still no flow.The physician decided remove the arterial sheath, close the artery and restick above the previous access site.The physician put in the.035 wire and then placed the enroute arterial sheath and created a non-flow limiting dissection in the proximal right common carotid artery.He decided to use a bmw wire to get out of the dissection plane into the true lumen of the common carotid artery (cca) but he was unable to and he decided to convert to a carotid endarterectomy (cea).No additional details were provided.

• Brand Name: ENROUTE TRANSCAROTID NEUROPROTECTION SYSTEM
• Type of Device: TEMPORARY CAROTID CATHETER FOR EMBOLIC CAPTURE
• Manufacturer (Section D): SILK ROAD MEDICAL, INC.; 1213 innsbruck dr.; sunnyvale CA 94089
• Manufacturer (Section G): SILK ROAD MEDICAL, INC.; 1213 innsbruck drive; sunnyvale CA 94089
• Manufacturer Contact: 1213 innsbruck dr.; sunnyvale, CA 94089
• MDR Report Key: 9269857
• MDR Text Key: 179307565
• Report Number: 3014526664-2019-00079
• Device Sequence Number: 1
• Product Code: NTE
• UDI-Device Identifier: 00811311020829
• UDI-Public: (01)00811311020829(17)220320(10)300566
• 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: 11/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/20/2022
• Device Model Number: SR-200-NPS
• Device Catalogue Number: SR-200-NPS
• Device Lot Number: 300566
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/07/2019
• 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: 85 YR