MAUDE Adverse Event Report: SILK ROAD MEDICAL ENROUTE TRANSCAROTID STENT; STENT, CAROTID

Model Number	SR-0840-CS
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Myocardial Infarction (1969); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/25/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
B3 - date of event: the event date was approximated to the date bsc became aware of the event, 04/25/2025.Further event details were not provided to bsc.We completed a good faith effort to obtain the information.Although a lot number was provided to bsc, the lot number was invalid.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.If additional details become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that a myocardial infarction occurred.An enroute transcarotid stent was implanted in an asymptomatic patient, during a right sided transcarotid artery revascularization (tcar) procedure.Sometime later, the patient suffered from a myocardial infarction.No further information was available to boston scientific.
Additional Manufacturer Narrative
Updated fields: b5 - describe event or problem.G1 - mfr site facility name, mfr site address 1, mfr site city, mfr site state, mfr site zip/post code.H6 - patient codes, impact codes, evaluation conclusion codes.B3 - date of event: the event date was approximated to the date bsc became aware of the event, 04/25/2025.Although a lot number was provided to bsc, the lot number was invalid.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.If additional details become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that a myocardial infarction occurred.An enroute transcarotid stent was implanted in an asymptomatic patient, during a right sided transcarotid artery revascularization (tcar) procedure.Sometime later, the patient suffered from a myocardial infarction.No further information was available to boston scientific.It was further reported that the study subject did not, in fact, experience a myocardial infarction.

• Brand Name: ENROUTE TRANSCAROTID STENT
• Common Device Name: STENT, CAROTID
• Manufacturer (Section D): SILK ROAD MEDICAL; 1213 innsbruck drive; sunnyvale CA 94089
• Manufacturer (Section G): SILK ROAD MEDICAL INC.; 14755 27th ave north plymouth; minneapolis MN 55447
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 22079835
• Report Number: 2124215-2025-33476
• Device Sequence Number: 8600618
• Product Code: NIM
• UDI-Device Identifier: 00811311020478
• UDI-Public: (01)00811311020478
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/20/2025

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 Model Number: SR-0840-CS
• Device Catalogue Number: SR-0840-CS
• Device Lot Number: 18047493
• 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: 04/25/2025
• Supplement Date Received by Manufacturer: 05/23/2025
• Initial Report FDA Received Date: 05/23/2025
• Supplement Report FDA Received Date: 06/20/2025
• 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: Life Threatening
• Patient Age: 69 YR
• Patient Sex: Female