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

Model Number SR-0840-CS

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 11/02/2016

Event Type  Injury  

Manufacturer Narrative

Clinical summary patient (b)(6): event: right hemispheric event 24 hours following uncomplicated right transcarotid artery revascularization (tcar) in an (b)(6) year old male with an asymptomatic 80% right carotid artery stenosis.Medical history: hypertension, hyperlipidemia, cerebrovascular disease; 80% left carotid artery stenosis, 50% right carotid artery stenosis, history of melanoma "of the arm", complex nodule in right lobe of thyroid (inconclusive prior ultrasound-guided fine needle aspiration), awaiting thyroidectomy, prior left mastoidectomy.Procedure: performed under general anesthesia.Surgical exposure of the right common carotid artery above the clavicle and percutaneous access to the left common femoral vein.Procedure completed under high flow rate flow reversal.The right internal carotid artery lesion (ica) was pre-dilated to 3mm followed by placement of an 8mm x 40mm enroute transcarotid stent.It was noted that there was a <30% residual waist in the stent.Post-procedure timeline: approximately 24 hours post right tcar, a stroke alert was called for a new right hemispheric neurological event affecting the left arm, left leg, left hemi-face and causing dysarthria and partial hemianopia.Nihss pre tcar: nihss post tcar: nihss 24 hours post tcar: 0.0.15.Ct scan of brain: 0843 hours.The ct scan indicated acute thrombotic occlusion of the right middle cerebral artery (mca) some 24 hours after uncomplicated right tcar and the patient was referred to interventional neuroradiology (inr) for neurorescue by mechanical aspiration thrombectomy of the right mca thrombus.Thrombus was aspirated out of the right mca.Although the thrombus was successfully extracted, follow-up ct scanning of brain revealed infarct in the right mca territory.Device implanted.

Event Description

Patient had a tcar (transcarotid artery revascularization) performed of (b)(6) on tuesday (b)(6) 2016 without incident.There were no deviations from procedural norms.Pre dilation of the vessel with subsequent stent dilation and no post dilation noted.However the patient, whom was taking therapeutic levels of asa/plavix was noted to not have taken his aspirin and plavix pre procedure.The patient was given aspirin and plavix immediately on arrival to pacu post procedure.At approximately 0810hrs on wednesday (b)(6) 2016, the patient experienced a neurological event.He was assessed and taken for evaluation.A thrombectomy was performed with successful thrombus removal and post dilatation of the enroute stent was performed.Patient was responding post procedure and is slated to be evaluated further.Devices were not returned because the procedure was completed per routine and the event occurred the day after device usage.

• Brand Name: ENROUTE TRANSCAROTID STENT SYSTEM
• Type of Device: ENROUTE SDS
• Manufacturer (Section D): SILK ROAD MEDICAL; 735 north pastoria avenue; sunnyvale CA 94085
• Manufacturer (Section G): SILK ROAD MEDICAL; 735 north pastoria avenue; sunnyvale CA 94085
• Manufacturer Contact: branka spremo ; 735 north pastoria avenue; sunnyvale, CA 94085 ; 4085852137
• MDR Report Key: 6137132
• MDR Text Key: 61187870
• Report Number: 3007215228-2016-00004
• Device Sequence Number: 1
• Product Code: NIM
• UDI-Device Identifier: 00811311020478
• UDI-Public: (01)00811311020478(17)180131(10)200487
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P140026
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 01/31/2018
• Device Model Number: SR-0840-CS
• Device Catalogue Number: SR-0840-CS
• Device Lot Number: 200487
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/02/2016
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 83 YR