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 Brain Injury (2219); Patient Problem/Medical Problem (2688)

Event Date 02/28/2019

Event Type  Injury  

Manufacturer Narrative

Mdr 301452666-2019-00007 is linked to the event.

Event Description

Patient had left sided tcar in (b)(6) 2018.Patient at some point discontinued their dual antiplatelet (dapt) therapy.Unsure regarding statin therapy compliance.We were informed the patient returned with in-stent restenosis on the left tcar target vessel at 90%.Repeat tcar performed yesterday on (b)(6) 2019 with only balloon angioplasty within the previous stent during eeg and neuro pulse oximetry performed.There was extensive scar tissue around the target vessel creating challenging access.There was a small incidental posterior wall injury that created a bit of oozing that took time to control.The patient remained on clamp for several additional minutes after the nps was discontinued to ensure oozing was controlled on the posterior cca.The patient awoke with slightly worse right arm weakness than baseline.Subsequent mri today on (b)(6) 2019 showed new small temporal infarcts indicating embolic or watershed type infarct (per physician) who also informed srm company representative that the patient presented 3 days ago with a new stroke (srm company representative was not aware of at the time of the procedure).Patient seems to be improving.There was no somatosensory evoked potential (ssep) changes or depression noted during the procedure.

• 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: 8406410
• MDR Text Key: 138360240
• Report Number: 3014526664-2019-00008
• Device Sequence Number: 1
• Product Code: NTE
• UDI-Device Identifier: 0081131120829
• UDI-Public: (01)0081131120829(17)191021(10)300135
• 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: 03/09/2019

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: 10/21/2019
• Device Model Number: SR-200-NPS
• Device Catalogue Number: SR-200-NPS
• Device Lot Number: 300135
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/28/2019
• Initial Date FDA Received: 03/09/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/18/2018
• 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: 61 YR