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 Problem Patient Problem/Medical Problem (2688)

Event Date 09/09/2019

Event Type  Injury  

Manufacturer Narrative

Out of an abundance of caution this is being reported, as it is unclear if the device contributed to this event or not.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 symptomatic patient underwent a transcarotid artery revascularization (tcar) procedure on (b)(6) 2019.Surgeons moved forward with the tcar procedure for this patient, even though this patient was not the ideal candidate for the tcar procedure.Two stents were placed because the stent needed to be deployed to the sheath tip.The patient did not wake up with neuro intact.The patient was immediately brought to computerized tomography (ct), which demonstrated that emboli was present in middle cerebral artery (mca).The patient was brought to neuro ir, where the doctor made several attempts to retrieve the disease.After successful retrieval, additional emboli was present in the a1 segment.The patient suffered a major stroke.The patient's family decided to remove all care plans moving forward.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 dr; sunnyvale CA 94089
• Manufacturer Contact: 1213 innsbruck dr. sunnyvale,; sunnyvale, CA 94089
• MDR Report Key: 9148372
• MDR Text Key: 167504314
• Report Number: 3014526664-2019-00076
• Device Sequence Number: 1
• Product Code: NTE
• UDI-Device Identifier: 00811311020829
• UDI-Public: (01)00811311020829(17)220128(10)300404
• 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: 10/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/28/2022
• Device Model Number: SR-200-NPS
• Device Catalogue Number: SR-200-NPS
• Device Lot Number: 300404
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/16/2019
• 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): Life Threatening; Required Intervention