MAUDE Adverse Event Report: SILK ROAD MEDICAL 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 Problem Vascular Dissection (3160)

Event Date 10/17/2022

Event Type  Injury  

Manufacturer Narrative

The product associated with this 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 led to the adverse event reported.A follow up mdr will be submitted when additional information is obtained.Complaints will continue to be reviewed and monitored for trends.

Event Description

It was reported that during a transcarotid artery revascularization (tcar) procedure, a dissection occurred with the enroute arterial sheath which required an unplanned stent to cover the dissection.The procedure was completed successfully with no health consequences or impact.

• Brand Name: ENROUTE TRANSCAROTID NEUROPROTECTION SYSTEM
• Type of Device: TEMPORARY CAROTID CATHETER FOR EMBOLIC CAPTURE
• Manufacturer (Section D): SILK ROAD MEDICAL; 1213 innsbruck drive; sunnyvale CA 94089
• Manufacturer (Section G): SILK ROAD MEDICAL INC.; 1213 innsbruck drive; sunnyvale CA 94089
• Manufacturer Contact: shelrin devi ; 1213 innsbruck drive; sunnyvale, CA 94089 ; 9169192746
• MDR Report Key: 15686560
• MDR Text Key: 302562978
• Report Number: 3014526664-2022-00168
• Device Sequence Number: 1
• Product Code: NTE
• UDI-Device Identifier: 00811311020829
• UDI-Public: (01)00811311020829(17)250601(10)302621
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: SR-200-NPS
• Device Catalogue Number: SR-200-NPS
• Device Lot Number: 302621
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/17/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/01/2022
• 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: 81 YR
• Patient Sex: Male