MAUDE Adverse Event Report: SILK ROAD MEDICAL ENROUTE TRANSCAROTID STENT SYSTEM; ENROUTE TSS

Model Number	SR-0740-CS
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/09/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product associated with this complaint has not been returned to the manufacturer yet.There was no patient harm reported, however if this malfunction were to reoccur, it potentially would contribute to a serious injury and therefore this complaint will be reported out of abundance of caution.A follow-up mdr will be submitted once additional information is received.Silk road medical will continue to monitor for occurrences of similar events.
Event or Problem Description
It was reported that during a tcar procedure, the tip of the stent delivery system (sds) was stuck in the lesion within the stent.Multiple manipulations and interventions were used to free the tip of the sds and the physician converted to a carotid endarterectomy (cea) procedure to resolve the issue.The procedure was completed successfully with no health consequences or impact to the patient.
Additional Manufacturer Narrative
The device investigation results did not identify any out-of-specification characteristics or product problems.Procedural and patient factors may have contributed to the withdrawal difficulties.
Event or Problem Description
This supplemental mdr is being submitted to update the b1 (adverse event or product problem) and h10-device investigation results for the initial report submitted on 02/07/2023.

• Brand Name: ENROUTE TRANSCAROTID STENT SYSTEM
• Common Device Name: ENROUTE TSS
• Manufacturer (Section D): SILK ROAD MEDICAL; 1213 innsbruck drive; sunnyvale CA 94089
• Manufacturer (Section G): SILK ROAD MEDICAL; 1213 innsbruck drive; sunnyvale CA 94089
• Manufacturer Contact: shelrin devi ; 1213 innsbruck drive; sunnyvale, CA 94089 ; 4087209002
• MDR Report Key: 16315125
• Report Number: 3014526664-2023-00007
• Device Sequence Number: 5759488
• Product Code: NIM
• UDI-Device Identifier: 00811311020447
• UDI-Public: (01)00811311020447(17)241231(10)18082996
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P140026
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/06/2023

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2024
• Device Model Number: SR-0740-CS
• Device Catalogue Number: SR-0740-CS
• Device Lot Number: 18082996
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/09/2023
• Supplement Date Received by Manufacturer: 03/30/2023
• Initial Report FDA Received Date: 02/07/2023
• Supplement Report FDA Received Date: 04/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/26/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 79 YR
• Patient Sex: Female