MAUDE Adverse Event Report: SILK ROAD MEDICAL ENROUTE TRANSCAROTID NEUROPROTECTION SYSTEM; ENROUTE NPS

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 12/10/2018

Event Type  Injury  

Event Description

Patient placed under ga.Bedside ultrasound completed.Identified 5.5-6cm of clean artery from clavicle to bifurcation.Patient prepped.Unremarkable cut down of left common carotid with a 2-3cm longitudinal incision.6500 units of intravenous heparin given.5.0 prolene purse string placed.Venous access gained with 6f cordis sheath.3-5 minutes after heparin administration, act obtained and confirmed an act of 261.Arterial access gained with enhance micro needle.Needle placed with black mark visualized and arterial bleedback noted, micro wire advanced to approximately 4cm, arterial micro sheath advanced to 3cm, micro wire and dilator removed, angiogram taken and since adequate runway was noted, stiff amplatz wire advanced to just below the bifurcation.Micropuncture sheath removed and arterial sheath placed.Upon inserting the arterial sheath, asked md to place foot on pedal to ensure we could visualize the wire.Wire was noted to have come back, it appeared to be at the tip of the sheath, md advanced the wire and advanced the sheath until he felt the silicone footplate on top of the artery.Physician supported the sheath at the artery and had his resident remove the dilator and wire, arterial blood return was noted in the sheath as he removed the wire and dilator.Physician supported the sheath proximally and had the resident take a picture to ensure placement in arterial lumen.Upon first angiogram, dissection was noted.Physician removed the sheath, tightened his purse string, and attempted to re-stick below the dissection plane.Physician placed an additional 5.0 prolene purse string where he believed it was nondissected, advanced his micropuncture needle, noted arterial bleedback, advanced his wire to 3cm, exchanged his needle for his micropuncture sheath.Advanced micropuncture sheath to 3cm, removed wire and dilator, took another angiogram, and he was noted to still be in the dissection plane.He removed his micro, tightened his purse string and discussed our options: re-sticking vs.Converting to cea.Physician ultimately decided that after assessing the artery, the dissection plane appeared to only be on the anterior wall.He stuck the medial wall of the artery.Same steps as noted past two times.Angiogram through micropuncture sheath confirmed he was still in the dissection plane.He converted to a cea.After cea was completed and patient woke up, patient was noted to be neurologically intact.I have checked in with the research coordinator and physician this morning, and the patient had an uneventful night.He is still neurologically intact and may be discharged later today.

• Brand Name: ENROUTE TRANSCAROTID NEUROPROTECTION SYSTEM
• Type of Device: ENROUTE NPS
• Manufacturer (Section D): SILK ROAD MEDICAL; 1213 innsbruck drive; sunnyvale CA 94089
• Manufacturer (Section G): SILK ROAD MEDICAL; 1213 innsbruck drive; sunnyvale CA 94089
• Manufacturer Contact: branka spremo ; 1213 innsbruck drive; sunnyvale, CA 94089 ; 4087209002
• MDR Report Key: 8418550
• MDR Text Key: 138771571
• Report Number: 3014526664-2019-00009
• Device Sequence Number: 1
• Product Code: NTE
• UDI-Device Identifier: 00811311020829
• UDI-Public: (01)00811311020829(17)190910(10)300028
• 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
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/13/2019

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: 09/10/2018
• Device Model Number: SR-200-NPS
• Device Catalogue Number: SR-200-NPS
• Device Lot Number: 300028
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/11/2018
• Initial Date FDA Received: 03/13/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/13/2018
• 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: 64 YR