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

Model Number	SR-0830-CS
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Stroke/CVA (1770); Hemorrhage/Blood Loss/Bleeding (1888); Thrombosis/Thrombus (4440); Restenosis (4576)
Date of Event	04/29/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
For section b2: the exact date of death is unknown.The product associated with this complaint was not returned to the manufacturer for analysis.A review of the manufacturing records for this device was completed and no issues were identified that could have led to the adverse event reported.At this time, it is unknown if the reported event is related to patient's underlying condition, procedural issues, resistance/non-compliance to medication, or a silk road medical device, hence, this event will be reported out of abundance of caution.Complaints will continue to be reviewed and monitored for trends.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 a few days after a right transcarotid artery revascularization (tcar) procedure, the patient presented with stroke like symptoms.Imaging revealed stent restenosis and the physician noted a diseased clot within the stent.The patient was then placed on lytic therapy to treat the diseased clot, which led to a hemorrhagic bleed and subsequent patient's demise.At this time, it is unknown if the reported event of stroke and restenosis are related to patient's underlying condition, procedural issues, resistance/non-compliance to medication, or a silk road medical device, hence, this event will be reported out of abundance of caution.
Additional Manufacturer Narrative
Additional/updated information can be found in the following fields: b4: date of this report.B5: describe event or problem.G6: type of report.H2: if follow up, what type? h11: additional manufacturer narrative.
Event or Problem Description
This supplemental mdr is being submitted to update section b5 per internal review: the patient's death is attributed to the administration of thrombolytic therapy which resulted in bleeding and a subarachnoid hemorrhage and is not related to a silk road medical device.

• 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: 19397446
• Report Number: 3014526664-2024-00105
• Device Sequence Number: 12501590
• Product Code: NIM
• UDI-Device Identifier: 00811311020461
• UDI-Public: (01)00811311020461(17)260731(10)18234322
• 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: 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
• Report Date (Section B): 07/01/2024

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2026
• Device Model Number: SR-0830-CS
• Device Catalogue Number: SR-0830-CS
• Device Lot Number: 18234322
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/29/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/24/2024
• Supplement Report FDA Received Date: 07/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/22/2023
• 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; Disability
• Patient Age: 67 YR
• Patient Sex: Female