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 Brain Injury (2219); Patient Problem/Medical Problem (2688)

Event Date 07/16/2019

Event Type  Injury  

Manufacturer Narrative

The product in complaint was not returned to the manufacturer for analysis.Therefore, the root cause of this adverse event cannot be identified at this time.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

An srm principal area manager was made aware from another physician on (b)(6) 2019 at 1pm, that a (b)(6) male with neck immobility suffered a stroke.The principal area manager located the physician at 2:30 pm and inquired about the case.The physician indicated that the stroke was observed immediately in the recovery room on (b)(6) 2019.The physician ordered a ct head and neck scan along with an mri of the brain.The ct brain scan was negative and the mri showed new brain white lesions, however, these were difficult to map to apparent diffusion coefficient (adc).Pre cta was performed which showed double angle, lengthy lesion with abundant low density material.Despite other recommendations, physician performed 4 mm x 3 cm pre, 9 mm x 4 cm post and 5 mm x 3 cm post dilation.There was an incidental finding of dissection in the ascending aorta.The patient was still in the hospital as of (b)(6) 2019.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 drive; sunnyvale CA 94089
• Manufacturer (Section G): SILK ROAD MEDICAL, INC.; 1213 innsbruck drive; sunnyvale CA 94089
• Manufacturer Contact: 1213 innsbruck drive; sunnyvale, CA 94089
• MDR Report Key: 8923832
• MDR Text Key: 155798162
• Report Number: 3014526664-2019-00061
• Device Sequence Number: 1
• Product Code: NTE
• UDI-Device Identifier: 00811311020829
• UDI-Public: (01)00811311020829(17)210206(10)300430
• 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: 08/22/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 02/06/2021
• Device Model Number: SR-200-NPS
• Device Catalogue Number: SR-200-NPS
• Device Lot Number: 300430
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/23/2019
• Initial Date FDA Received: 08/22/2019
• 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: 73 YR