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

Model Number SRE-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 07/30/2019

Event Type  Injury  

Manufacturer Narrative

The product in complaint was not returned to the manufacturer for analysis.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 during a transcarotid artery revascularization (tcar) procedure on an (b)(6) symptomatic patient; a dissection occurred in the right internal carotid artery (rica).The dissection occurred possibly at arterial sheath insertion, as it wasn't observed previously.It was reported there was some resistance upon introduction of the arterial sheath.An attempt was made to wire the true lumen, which was unsuccessful.The decision was made to convert to carotid endarterectomy (cea).Upon viewing the angiographic imaging, it was felt that the vessel had significant tortuousity in which cea would be more amenable as opposed to stenting.For that reason, no further efforts were made to either re-puncture or try to find the true lumen.Patient is neuro intact with no adverse events.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 ; 4087209013
• MDR Report Key: 8942670
• MDR Text Key: 160512421
• Report Number: 3014526664-2019-00063
• Device Sequence Number: 1
• Product Code: NTE
• UDI-Device Identifier: 00811311020812
• UDI-Public: (01)00811311020812(17)191105(10)201536
• Combination Product (y/n): N
• Reporter Country Code: PL
• PMA/PMN Number: K153485
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/05/2019
• Device Model Number: SRE-200-NPS
• Device Catalogue Number: SRE-200-NPS
• Device Lot Number: 201536
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/30/2019
• 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: 80 YR