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

Model Number	SR-0740-CS
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Thrombosis (2100)
Date of Event	08/22/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Patient information: (b)(6) female with a history of coronary artery disease with five stents, hypertension, hyperlipidemia, smoking, thrombocytopenia, gi bleed, chronic obstructive airways disease, acute kidney injury, hypothyroidism, congestive heart failure, diabetes mellitus and bilateral carotid stenosis each side >80%, headaches and r leg paresthesia, (questionable tia).Procedural history: a left sided tcar procedure was performed on (b)(6) 2017 at (b)(6) hospital, (b)(6).The procedure was technically straightforward, however, the patient was slow to awaken post-procedure, and was discovered to have a right sided hemiplegia.The decision was made to re-open the neck incision above the left clavicle.10,000 units of heparin were administered, intravenously, integrilin (a glycoprotein iib/iiia inhibitor and tpa (tissue plasminogen activator) ordered.The stent in the left internal carotid/common carotid artery was found to be thrombosed.A series of 2-3-4-5 fogarty catheters were used to perform thrombectomy, combined with a back-bleeding method to thrombectomize the stent.Tpa was administered.After angiographically determining the thrombus was removed, a drain was placed and the patient was awoken.Clinically, there was no improvement and ct of the head and neck was performed.The stent was noted to be patent.Diffusion weighted magnetic resonance imaging (dwmri) of brain performed the next day showed "patchy areas of restricted diffusion in the left middle cerebral artery distribution suggesting interval infarct." the following day, ct of brain was performed and demonstrated "low density in the left caudate head and left basal ganglia which appears new since the previous exam.This is non-specific , and considerations include edema, evolving left middle cerebral artery infarcts, or artifact due to the obliquity of the head in the scanner.No hemorrhage, mass effect or midline shift".The patient received a tracheotomy on the same day.Since the procedure, there has been no improvement to r-arm and leg function.It was considered that the hyperacute stent occlusion was likely due to questionable compliance with the mandatory dual antiplatelet regime (aspirin and clopidogrel) or potentially insensitivity to clopidogrel.Of note, the patient's cardiologist from an outside hospital asked the patient to withhold prasugrel five days prior to tcar it was unclear whether the patient had received appropriate loading doses of aspirin and clopidogrel prior to tcar.There were no mechanical issues with the stent, which had deployed accurately with good wall apposition and without propagating a kink into the distal left internal carotid artery.End.
Event or Problem Description
Acute stent occlusion post left sided transcarotid artery revascularization (tcar).Patient required surgical re-intervention (thrombectomy) after patient unable to demonstrate movement of r-arm and r-leg upon awakening.Patient sent for follow-up cta immediately post-surgical re-intervention.

• Brand Name: ENROUTE TRANSCAROTID STENT SYSTEM
• Common Device Name: ENROUTE SDS
• Manufacturer (Section D): SILK ROAD MEDICAL; 735 north pastoria avenue; sunnyvale CA 94085
• MDR Report Key: 6881498
• Report Number: 3007215228-2017-00005
• Device Sequence Number: 16307730
• Product Code: NIM
• UDI-Device Identifier: 00811311020447
• UDI-Public: (01)00811311020447(17)180831(10)200702
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P140026
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/20/2017

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: Physician
• Device Expiration Date: 08/31/2018
• Device Model Number: SR-0740-CS
• Device Catalogue Number: SR-0740-CS
• Device Lot Number: 200702
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/22/2017
• Initial Report FDA Received Date: 09/20/2017
• 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: 51 YR