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

Model Number	SR-1040-CS
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	Muscle Weakness/Atrophy (1967)
Date of Event	06/12/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 procedural issues, patient anatomy, or contribution from 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 right transcarotid artery revascularization (tcar) procedure, upon waking, the patient experienced left-sided weakness.Further, it was noted that the arterial line was not transmitting and there was difficulty getting a non-invasive blood pressure.Due to the left sided weakness, blood pressure & stridor with breathing issue, a stroke code was initiated, and the physician placed a femoral arterial line to maintain blood pressure.Imaging revealed perfusion deficit and deformation of the stent post-implantation.The deformation of the stent was later found to be due to patient's anatomy and calcification.During the initial tcar, the physician chose to pre-dilate the lesion, but not to post-dilate the stent.Thus, the physician elected to re-treat the patient via tcar to post-dilate the stent.After the treatment, the patient's movement on the left side improved.The physician initially believed the patient had a perfusion deficit and stroke, but mri imaging was negative for stroke.Ct perfusion indicated stent patency with no embolization, plaque prolapse or thrombus.At this time, it is unknown if the reported event is related to procedural issues, patient anatomy, or contribution from 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: 19669392
• Report Number: 3014526664-2024-00131
• Device Sequence Number: 15162372
• Product Code: NIM
• UDI-Device Identifier: 00811311020539
• UDI-Public: (01)00811311020539(17)261031(10)18258575
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/03/2024

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 Model Number: SR-1040-CS
• Device Catalogue Number: SR-1040-CS
• Device Lot Number: 18258575
• 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: 06/12/2024
• Initial Report FDA Received Date: 07/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/13/2023
• 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: 76 YR
• Patient Sex: Female