MAUDE Adverse Event Report: SILK ROAD MEDICAL, INC ENROUTE TRANSCAROTID NEUROPROTECTION SYSTEM; TEMPORARY CAROTID CATHETER FOR EMBOLIC CAPTURE

Model Number SR-200-NPS

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

Patient Problems Patient Problem/Medical Problem (2688); Vascular Dissection (3160)

Event Date 08/26/2019

Event Type  Injury  

Manufacturer Narrative

The product in complaint was not returned to the manufacturer for evaluation.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.Complaints will continue to be monitored for any trends.

Event Description

It was reported that an (b)(6) year old asymptomatic male patient underwent a left transcarotid artery revascularization (tcar) procedure on (b)(6) 2019.Access was achieved by engaging the external carotid artery (eca) and dilating the artery with an 8 fr dilator.The 8 fr sheath was placed successfully.After securing the sheath with two sutures, the angiogram demonstrated distal common carotid artery (cca) bifurcation.Artery was clamped and reverse flow was confirmed.The physician experienced difficulties when wiring the lesion with a.014 wire.He stated that the wire seemed to be in a dissection plane.An angled catheter and various wires were utilized.The lesion was successfully wired with a (balanced middle weight) wire.The physician proceeded to pre-dilate the internal carotid artery (ica) and deployed two stents to cover the lesion.The post dilation overlap of the two stents was performed.Another angiogram in two views was performed which demonstrated good stent placement.However, a dissection near the sheath tip was observed.The physician pulled the sheath back to better appreciate the dissection and decided to deploy a stent in the mid/proximal common carotid artery (cca).The stent delivery system was safely removed from sheath.The patient woke with neuro in tact.No additional details were provided.

• Brand Name: ENROUTE TRANSCAROTID NEUROPROTECTION SYSTEM
• Type of Device: TEMPORARY CAROTID CATHETER FOR EMBOLIC CAPTURE
• 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: 1213 innsbruck drive; sunnyvale, CA 94089
• MDR Report Key: 9050807
• MDR Text Key: 162703742
• Report Number: 3014526664-2019-00071
• Device Sequence Number: 1
• Product Code: NTE
• UDI-Device Identifier: 00811311020829
• UDI-Public: (01)00811311020829(17)220117(10)300377
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K153485
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/13/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 01/17/2022
• Device Model Number: SR-200-NPS
• Device Catalogue Number: SR-200-NPS
• Device Lot Number: 300377
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/26/2019
• Initial Date FDA Received: 09/13/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• 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: 86 YR