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

Model Number	SR-1030-CS
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Ischemia Stroke (4418)
Date of Event	04/07/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that after completion of a transcarotid artery revascularization (tcar) procedure, the patient was experienced stroke symptoms that included weakness and aphasia.Computed tomography angiography (cta) imaging performed showed that the stent was patent, and there was no acute blockage or hemorrhage.Additionally, magnetic resonance imaging (mri) revealed middle cerebral artery (mca) infarcts.Additional information obtained indicated that the during the tcar procedure, the physician ballooned the overlap zone between the two stents with a 6x30 balloon.On the angiogram, plaque identified on one view.A second view was taken with contrast injected.When the physician went back to the first view, the original image did not look the same.No further intervention was reported, and patient was noted to be at baseline two days post-procedure.At this time, it is unclear if the stroke symptoms experienced by the patient is related to a device issue hence, the event will be reported out of abundance of caution.
Additional Manufacturer Narrative
The product associated with this complaint was not returned to the manufacturer for analysis.The cause of the post-operative complication is unknown.This report is being submitted out of an abundance of caution.Investigation is ongoing and results are not yet available.A follow-up mdr will be submitted when additional information is obtained.Silk road medical will continue to monitor for occurrences of similar events.A secondary mdr is submitted under 3500a form # 3014526664-2022-00057 since at this time it is unknown which device may have caused or contributed to the reported event.
Additional Manufacturer Narrative
H10: additional manufacturer narrative: a follow-up mdr is being submitted to reflect the additional information obtained on may 18, 2022.A review of manufacturing records for this device was completed, and no issues were identified that could have led to the adverse event reported.The product associated with this complaint was not returned to the manufacturer for analysis.There is no indication that a malfunction of the srm device occurred, the cause of the post-operative complication is unknown.A follow-up mdr will be submitted if additional information is obtained.Silk road medical will continue to monitor for occurrences of similar events.

• Brand Name: ENROUTE TRANSCAROTID STENT SYSTEM
• Common Device Name: TSS
• Manufacturer (Section D): SILK ROAD MEDICAL INC.; 1213 innsbruck drive; sunnyvale CA 94089
• Manufacturer (Section G): SILK ROAD MEDICAL INC.; 1213 innsbruck drive; sunnyvale CA 94089
• Manufacturer Contact: yvonne nguyen ; 1213 innsbruck drive; sunnyvale, CA 94089 ; 4087209002
• MDR Report Key: 14323525
• Report Number: 3014526664-2022-00070
• Device Sequence Number: 5269851
• Product Code: NIM
• UDI-Device Identifier: 00811311020522
• UDI-Public: (01)00811311020522(17)240229(10)18012726
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P140026
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/13/2022

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: 02/29/2024
• Device Model Number: SR-1030-CS
• Device Catalogue Number: SR-1030-CS
• Device Lot Number: 18012726
• 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: 04/07/2022
• Supplement Date Received by Manufacturer: 05/18/2022
• Initial Report FDA Received Date: 05/07/2022
• Supplement Report FDA Received Date: 06/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/26/2021
• 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: Other
• Patient Age: 78 YR
• Patient Sex: Male