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 Thrombus (2101); Weakness (2145); Numbness (2415)

Event Date 06/20/2019

Event Type  Injury  

Manufacturer Narrative

No product was returned to the manufacturer for evaluation.Therefore, a definitive cause of the reported event is unable to be determined.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.Additionally, this was the first reported adverse event of this nature associated with this lot.Monitoring will continue to be performed for this lot.Complaints will continue to be monitored for any trends.

Event Description

It was reported that a tcar procedure performed in (b)(6) 2019 was uneventful with regards to access.The dual antiplatelet therapy (dapt) protocol was followed and all tcar steps including tcar timeout were performed.Pre-dilation with a 5mmx20mm balloon was performed and a 9mmx30mm stent was placed without incidence.The patient woke up fine and was able to respond to basic commands before leaving the room.However, forty-eight hours after completion of the procedure, the patient reported numbness and weakness in the left hand.The hospital conducted a follow up ct scan and radiology observed two small infarctions.The ct scan showed a small dark crescent mid stent on the axial cuts, presumably a clot.The patient was placed on a heparin drip and was improving or improved at the time of discharge.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: cynthia chiu ; 1213 innsbruck drive; sunnyvale, CA 94089 ; 4087209002
• MDR Report Key: 8834099
• MDR Text Key: 152493725
• Report Number: 3014526664-2019-00054
• Device Sequence Number: 1
• Product Code: NTE
• UDI-Device Identifier: 00811311020829
• UDI-Public: (01)00811311020829(17)220117(10)300377
• 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: 07/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/17/2022
• Device Model Number: SR-200-NPS
• Device Catalogue Number: SR-200-NPS
• Device Lot Number: 300377
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/01/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/17/2019
• 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: 67 YR