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 08/20/2019

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 a (b)(6) year old male underwent a transcarotid artery revascularization (tcar) procedure on (b)(6) 2019.It was observed that upon initial access the micro puncture wire was lost.A second stick was made via the original needle hole with the micro needle and micro wire access was obtained, the wire tip was observed to be spinning freely within the left common carotid artery (lcca).The micro sheath was then advanced between the 2-3 cm mark and an unremarkable angiogram was obtained.The 0.35 j wire was advanced short of the proximal lcca lesion and the arterial sheath was inserted approximately 2 cm into the lcca.Two views of the arterial sheath tip were obtained.At this point the arterial sheath tip was observed and thought to be abutted against the back wall of the lcca.The physician decided to withdraw the arterial sheath then reinsert the 0.35 j wire and dilator, advancing until the footplate was against the artery wall.The physician then obtained 2 more views of the arterial sheath and these views were unremarkable.The enroute ® transcarotid neuroprotection system was connected and acceptable unprotected flow was assessed.Once blood pressure and heart rate bp/hr were within acceptable ranges the lcca was clamped and protected flow reversal was obtained.At this time the physician attempted to cross the lcca lesion with the enroute 0.014 wire.During multiple attempts to cross the lesion the physician suspected that a dissection may have occurred.Another angiogram was performed which showed no evidence of a dissection.A final attempt to cross the lcca lesion was made.During this attempt a dissection was suspected and confirmed.The physician made the decision to abandon the tcar procedure and attempt to perform an open carotid endarterectomy (cea).This open attempt was also abandoned due do adhesion of tissue planes as a result of previous neck radiation.The physician therefore made the decision to perform transfemoral carotid artery stenting (tf-cas) and successfully gained access to the left internal carotid artery (lica).A 4x30 balloon was used to pre-dilate the lica and lcca lesion and 8x40 and 9x40 cordis precise stents were placed.A 5x20 balloon was used to post-dilate the lcca stent stenosis.A final angiogram was obtained demonstrating anti-grade flow with no evidence of dissection.The patient woke up from general anesthesia neurologically intact.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 dr.; sunnyvale CA 94089
• Manufacturer Contact: 1213 innsbruck dr.; sunnyvale, CA 94089
• MDR Report Key: 9050801
• MDR Text Key: 162705600
• Report Number: 3014526664-2019-00068
• Device Sequence Number: 1
• Product Code: NTE
• UDI-Device Identifier: 00811311020829
• UDI-Public: (01)00811311020829(17)220213(10)300445
• 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: 02/13/2022
• Device Model Number: SR-200-NPS
• Device Catalogue Number: SR-200-NPS
• Device Lot Number: 300445
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/20/2019
• Initial Date FDA Received: 09/13/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/30/2019
• 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: 69 YR