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

Model Number SR-0740-CS

Device Problem Difficult to Remove (1528)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/09/2023

Event Type  Injury  

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 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.

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 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
• Type of Device: 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
• MDR Text Key: 309010761
• Report Number: 3014526664-2023-00007
• Device Sequence Number: 1
• Product Code: NIM
• UDI-Device Identifier: 00811311020447
• UDI-Public: (01)00811311020447(17)241231(10)18082996
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• 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
• Initial Date Manufacturer Received: 01/09/2023
• Initial Date FDA Received: 02/07/2023
• Supplement Dates Manufacturer Received: 03/30/2023
• Supplement Dates FDA Received: 04/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/26/2022
• 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: 79 YR
• Patient Sex: Female