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

Model Number	SR-0830-CS
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Brain Injury (2219); Convulsion/Seizure (4406); Thrombosis/Thrombus (4440)
Date of Event	08/10/2020
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 lead to the adverse event reported.A followup mdr will be submitted if additional information is obtained.Silk road medical will continue to monitor for occurrences of related events.Out of an abundance of caution, this complaint is being reported as it is unclear if the adverse event was caused by the procedure, a patient response, or the device.A secondary mdr is submitted under 3500a form # 3014526664-2020-00081 since at this time it is unknown which device may have caused or contributed to the reported event.
Event or Problem Description
The patient underwent a transcarotid artery revascularization (tcar) procedure.Upon removal of enroute arterial sheath protamine was requested by the physician.After the access site was closed, the patient was awake, able to speak and move arms and legs.The patient then became hypotensive, tachycardic, and itchy.The anesthesiologist started epinephrine drip to stabilize the patient and the patient was able to respond to all commands with all extremities.Later that same day, the patient was not moving her left side and received a ct scan with contrast.The patient was brought back to the operating room to have the enroute stent removed.The patient's status did not change post explant, and the patient experienced seizures and intraparenchymal bleeds overnight.The following day, the patient was speaking and able to move her left leg.A video review was performed after the tcar procedure that showed stent compression at the proximal internal carotid artery (ica) with what appeared to be mural thrombus in the distal end of the stent.The angiograms taken from femoral artery access during re-intervention showed the stent patent with approximately 30-50% residual stenosis.The physician's partner believed the thrombus was perhaps due to protamine.The anesthesiologist believed the patient had a substantial protamine reaction during the tcar procedure.

• Brand Name: ENROUTE TRANSCAROTID STENT SYSTEM
• Common Device Name: ENROUTE SDS
• Manufacturer (Section D): SILK ROAD MEDICAL INC.; 1213 innsbruck drive; sunnyvale CA 94089
• MDR Report Key: 10505207
• Report Number: 3014526664-2020-00080
• Device Sequence Number: 2445619
• Product Code: NIM
• UDI-Device Identifier: 00811311020461
• UDI-Public: (01)00811311020461(17)211231(10)17922179
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: P140026
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/08/2020

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: 12/31/2021
• Device Model Number: SR-0830-CS
• Device Catalogue Number: SR-0830-CS
• Device Lot Number: 17922179
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/10/2020
• Initial Report FDA Received Date: 09/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 61 YR