MAUDE Adverse Event Report: SILK ROAD MEDICAL, INC ENROUTE TRANSCAROTID STENT SYSTEM; ENROUTE SDS

Model Number SR-0840-CS

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Muscle Weakness (1967); Patient Problem/Medical Problem (2688)

Event Date 03/18/2019

Event Type  Injury  

Manufacturer Narrative

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.Therefore, the root cause of this adverse event cannot be identified at this time.

Event Description

Patient had a tcar procedure and days later returned to the hospital with complaints of right arm weakness over the weekend that resolved in a few hours.A ct was performed and the stent that was placed during the tcar procedure was occluded.The patient's symptoms resolved with no further intervention.In regards to the procedure, the patient was on asa, statin, and plavix, and post-op, the patient woke up moving all extremities.According to the physician, the patient was compliant with his medication regimen post procedure.

• Brand Name: ENROUTE TRANSCAROTID STENT SYSTEM
• Type of Device: ENROUTE SDS
• 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: mai-ly wilcox ; 1213 innsbruck drive; sunnyvale, CA 94089 ; 4087209002
• MDR Report Key: 8507126
• MDR Text Key: 141724227
• Report Number: 3014526664-2019-00024
• Device Sequence Number: 1
• Product Code: NIM
• UDI-Device Identifier: 00811311020478
• UDI-Public: (01)00811311020478(17)200430(10)300197
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P140026
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2020
• Device Model Number: SR-0840-CS
• Device Catalogue Number: SR-0840-CS
• Device Lot Number: 300197
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/20/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/07/2018
• 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): Hospitalization
• Patient Age: 75 YR