STENT, CAROTID

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-11 for STENT, CAROTID manufactured by Silk Road Medical, Inc.

Event Text Entries

[178574071] 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.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 9693289
• MDR Report Key: 9693289
• Date Received: 2020-02-11
• Date of Report: 2020-02-06
• Date of Event: 2020-01-06
• Report Date: 2020-02-06
• Date Reported to FDA: 2020-02-06
• Date Reported to Mfgr: 2020-02-11
• Date Added to Maude: 2020-02-11
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: RISK MANAGER
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Generic Name: STENT, CAROTID
• Product Code: NIM
• Date Received: 2020-02-11
• Lot Number: 17871467
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Eval'ed by Mfgr: *
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: SILK ROAD MEDICAL, INC
• Manufacturer Address: 1213 INNSBRUCK DRIVE SUNNYVALE CA 94089 US 94089

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other; 2. Required No Informationntervention	2020-02-11