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 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 evaluation.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 a (b)(6) year old male patient underwent a right transcarotid artery revascularization (tcar) procedure on (b)(6) 2020.When the physician attempted to insert the enroute.035 wire, it was not stabilized upon enroute sheath insertion.The physician pulled back from the external carotid into the proximal common carotid artery (cca) which appeared to cause a dissection in the patient's cca.The physician then attempted to rotate the sheath advance the wire, but this was unsuccessful.A decision was then made to close the arteriotomy with a pre-close stitch and re-access.The physician then placed new pre-close stitch slightly distal to prior access.The enhance.018 access wire would not advance either, therefore the physician decided to close that access as well and convert to cea (carotid endarterectomy).The physician successfully performed the cea on the right internal carotid artery (rica).Using imaging to reassess post flow dynamics the physician noticed the dissection flap in the mid common carotid artery.The physician then gained retrograde access in the rica and proceeded with stenting (enroute stent 8x30) the mid rica in a retrograde fashion.The physician was satisfied with the final imaging and completed the case.The patient was extubated and was able to follow commands, moving all 4 extremities without difficulty.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
• Manufacturer (Section G): SILK ROAD MEDICAL, INC.; 1213 innsbruck dr; sunnyvale,, ca
• Manufacturer Contact: 1213 innsbruck dr. sunnyvale,; sunnyvale, ca
• MDR Report Key: 9758478
• MDR Text Key: 189081818
• Report Number: 3014526664-2020-00040
• Device Sequence Number: 1
• Product Code: NTE
• 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: 02/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/18/2022
• 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: 71 YR