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

Model Number SR-1040-CS

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

Patient Problems Death (1802); Patient Problem/Medical Problem (2688)

Event Date 04/09/2019

Event Type  Death  

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.This event is being reported out of an abundance of caution.

Event Description

A normal tcar procedure was performed.The patient was high risk based off of a lesion.After the procedure, the staff tried to wake the patient, but the patient was unresponsive.An ultrasound was performed on the patient and it was noted that the stent was occluded.A cea procedure was performed to remove the stent.During the procedure, a large clot in the middle of the stent was discovered.After the cea procedure, the patient had a massive stroke and passed away.It was noted that the patient had an intraluminal filling defect, resulting in plaque prolapse.

• Brand Name: ENROUTE TRANSCAROTID STENT SYSTEM
• Type of Device: STENT 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
• MDR Report Key: 8591776
• MDR Text Key: 144445403
• Report Number: 3007215228-2019-00028
• Device Sequence Number: 1
• Product Code: NIM
• 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: 05/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 10/31/2019
• Device Model Number: SR-1040-CS
• Device Catalogue Number: SR-1040-CS
• Device Lot Number: 201265
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/10/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/15/2017
• 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): Death
• Patient Age: 78 YR