MAUDE Adverse Event Report: CORDIS CORPORATION CORDIS PRECISE CAROTID STENT; STENT, CAROTID

Device Problem Material Separation (1562)

Patient Problem Insufficient Information (4580)

Event Date 11/09/2020

Event Type  malfunction  

Event Description

Cordis precise stent used to perform trans carotid artery revascularization (tcar) using silk road flow reversal device.During procedure there was separation of distal marker of the shaft.This was then retrieved with a snare to prevent distal embolization.Fda safety report id # (b)(4).

• Brand Name: CORDIS PRECISE CAROTID STENT
• Type of Device: STENT, CAROTID
• Manufacturer (Section D): CORDIS CORPORATION
• MDR Report Key: 10843566
• MDR Text Key: 216923247
• Report Number: MW5097884
• Device Sequence Number: 1
• Product Code: NIM
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2020
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 75 YR
• Patient Weight: 113