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

Model Number	SR-0940-CS
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Muscle Weakness/Atrophy (1967); Ischemia Stroke (4418); Thrombosis/Thrombus (4440)
Date of Event	06/06/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A secondary mdr was reported under 3014526664-2024-00128 as there were two products associated with this event.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 lesion characteristics, procedural issues, patient resistance/ noncompliance to medication, or a silk road medical device, hence, the 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 after a left transcarotid artery revascularization (tcar) procedure, during the neurological exam, the patient was not moving his contralateral limbs.Imaging revealed an occluded vessel, and the physician explanted the stents and converted the procedure to a carotid endarterectomy (cea).After explanation of the stent, it was confirmed that there was no thrombus within the stent.During the cea procedure, imaging further revealed a clot occluding the distal internal carotid artery (ica) for which the physician performed a thrombectomy using a third-party aspiration catheter.The patient's stroke symptoms have completely resolved.It was noted that this patient had presence of intraluminal thrombus extending to the petrous ridge at the skull base.The enroute transcarotid stent system ifu warns under the 'patient selection warnings' : "safety and effectiveness of the enroute transcarotid stent system has not yet been established for patients with evidence of intraluminal thrombus thought to increase the risk of plaque fragmentation and distal embolization".However, these lesions are not contraindicated in the ifu.At this time, it is unknown if the reported event is related to patient lesion characteristics, procedural issues, patient resistance/non-compliance to medication, or a silk road medical device, hence, the event will be reported out of abundance of caution.

• 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: 19620452
• Report Number: 3014526664-2024-00127
• Device Sequence Number: 6520254
• Product Code: NIM
• UDI-Device Identifier: 00811311020508
• UDI-Public: (01)00811311020508(17)260731(10)18230605
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/26/2024

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-0940-CS
• Device Catalogue Number: SR-0940-CS
• Device Lot Number: 18230605
• 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: 06/06/2024
• Initial Report FDA Received Date: 06/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/08/2023
• 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: 67 YR
• Patient Sex: Male