MAUDE Adverse Event Report: SILK ROAD MEDICAL, INC; STENT, CAROTID

Lot Number 17871467

Device Problem Positioning Problem (3009)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/06/2020

Event Type  Injury  

Event Description

Physician was attempting to place stent in right internal carotid artery.After stent was placed and completion angiogram was performed, it was discovered that the stent was inadvertently placed in the external carotid.The wire was re-positioned and a second self-expanding stent was placed.Completion angiogram showed good positioning of the stent in the internal carotid artery, but some residual indentation about bifurcation.Area was dilated with balloon catheter and final angiogram showed restored luminal diameter with no evidence of intimal dissection or extravasation.

• Type of Device: STENT, CAROTID
• Manufacturer (Section D): SILK ROAD MEDICAL, INC; 1213 innsbruck drive; sunnyvale CA 94089
• MDR Report Key: 9693289
• MDR Text Key: 178574071
• Report Number: 9693289
• Device Sequence Number: 1
• Product Code: NIM
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 02/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Lot Number: 17871467
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/06/2020
• Event Location: Hospital
• Date Report to Manufacturer: 02/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 24455 DA