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

Model Number	SR-0940-CS
Medical Device Problem Codes	Difficult to Remove (1528); Material Deformation (2976); Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/02/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product associated with this complaint is pending return.There was no patient harm reported, however, intervention was taken to prevent injury and therefore this complaint will be reported out of abundance of caution.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.If additional information is received, a supplemental report will be filed.
Event or Problem Description
It was reported that during a left transcarotid artery revascularization (tcar) procedure, while removing the enroute transcarotid stent system (tss), the tss caught on the stent and pulled the distal portion of the stent into the proximal segment.The stent was excised, and an unplanned additional stent was placed.The procedure was completed successfully with no further complications reported.
Additional Manufacturer Narrative
The inspection of the returned stent delivery system (sds) did not identify any non-conformances; however, the stent was not returned for analysis.The customer reported complaint could not be confirmed.The exact cause of the reported event could not be conclusively determined during the analysis.
Event or Problem Description
This supplemental mdr is being submitted to update the h11 device investigation results for the initial report submitted on 04/26/2024.
Additional Manufacturer Narrative
Additional information can be found in the following fields: b4: date of this report.G3: date received by manufacturer.G6: type of report.H2: if follow up, what type? h3: device evaluated by manufacturer? h6: type of investigation.H11: additional manufacturer narrative.The stent delivery system (sds) and deployed stent were returned for analysis.The complaint reported by the customer regarding difficult removal and unintended movement of the delivery system could not be confirmed.The dimensional analysis indicated the device to be within specifications.The stent was found to be fractured upon return.The customer did not report a fractured stent, and the cause of the fracture could not be definitively determined.It was reported that during the procedure, the stent was pulled in on itself during withdrawal from the delivery system.The procedural factors and handling associated with this may have contributed to the observed fracture.The product analysis does not suggest that the observed damage is related to the manufacturing process.
Event or Problem Description
This supplemental mdr is being submitted to update the h11 device investigation results for the initial report submitted on 04/26/2024.

• Brand Name: ENROUTE TRANSCAROTID STENT SYSTEM
• Common Device Name: ENROUTE TSS
• Manufacturer (Section D): SILK ROAD MEDICAL; 1213 innsbruck dr.; sunnyvale CA 94089
• Manufacturer (Section G): SILK ROAD MEDICAL; 1213 innsbruck dr.; sunnyvale CA 94089
• Manufacturer Contact: vincent lopez mireles ; 1213 innsbruck dr.; sunnyvale, CA 94089 ; 4087209002
• MDR Report Key: 19196933
• Report Number: 3014526664-2024-00087
• Device Sequence Number: 18262900
• Product Code: NIM
• UDI-Device Identifier: 00811311020508
• UDI-Public: (01)00811311020508(17)260731(10)18234751
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P140026
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• 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,Followup
• Report Date (Section B): 09/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2026
• Device Model Number: SR-0940-CS
• Device Catalogue Number: SR-0940-CS
• Device Lot Number: 18234751
• 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: 04/02/2024
• Supplement Date Received by Manufacturer: 06/27/2024; 08/14/2024
• Initial Report FDA Received Date: 04/26/2024
• Supplement Report FDA Received Date: 07/24/2024; 09/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/25/2023
• 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: 61 YR
• Patient Sex: Male