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

Model Number SR-0940-CS

Device Problem Break (1069)

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

Event Date 06/29/2023

Event Type  Injury  

Manufacturer Narrative

The stent delivery system (sds) and the stent were returned for investigation.Upon visual inspection, it was observed that there was a partial stent strut breakage and distal to the breakage, there was unknown material constricting the diameter of the stent, resulting in an hourglass shape.Material identification was performed, and based on the results obtained, it was suggested that the material has a composition similar to human tissue.It was determined that the reported pinch point was caused by intimal tissue wrapped around the stent.The reported inability of the stent to open in vivo but fully expanding post-tissue removal from the stent was determined to be consistent with the stent being inadvertently implanted across a dissection of the intimal tissue.The strut breakage is consistent with the handling of the device, attempts to re-sheath and explant of device with no evidence of the breakage present prior to these actions.There is no evidence to suggest that this device failed to meet specifications before distribution.Silk road medical will continue to monitor for occurrences of similar events.All reasonably available information has been provided by the company at the time of submission of this report.The fields that are blank are not an omission and indicate that the information is either not applicable or currently unavailable.A follow-up mdr will be submitted if additional information is received.

Event Description

It was initially reported on (b)(6) 2023 that during a t-car procedure, the stent did not expand upon deployment at the distal quarter of the stent.The physician attempted to remove the stent and was unsuccessful.The physician converted the procedure to carotid endarterectomy and explanted the stent, and indicated the stent was open at the distal end, but a pinch point was noted around the distal quarter of the stent.On (b)(6) 2024, it was clarified that tension was observed when attempting to remove the delivery catheter versus the stent as previously stated.This was because the nose cone could not be passed through the pinch-point of the stent.Due to the inability to remove the stent delivery system, the procedure was converted.Although there was no harm or injury to the patient, this event is classified as a reportable complaint since surgical intervention was performed to address the stent location issue and prevent permanent impairment of a body function or permanent damage to a body structure.

• 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: 18813256
• MDR Text Key: 336615865
• Report Number: 3014526664-2024-00029
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/29/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: SR-0940-CS
• Device Catalogue Number: SR-0940-CS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/26/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/12/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/15/2022
• 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: 78 YR
• Patient Sex: Male