MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION CAROTID WALLSTENT MONORAIL ENDOPROSTHESIS; STENT, CAROTID

Catalog Number 71-902

Device Problem Positioning Failure (1158)

Patient Problem No Information (3190)

Event Date 05/01/2015

Event Type  malfunction  

Event Description

The device would not track over wire and the stent deployed prematurely.Stent did not deploy in patient, but could have caused a stroke.

• Brand Name: CAROTID WALLSTENT MONORAIL ENDOPROSTHESIS
• Type of Device: STENT, CAROTID
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 4787214
• MDR Text Key: 16862461
• Report Number: 4787214
• Device Sequence Number: 1
• Product Code: NIM
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 05/04/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Invalid Data
• Device Catalogue Number: 71-902
• Device Lot Number: 17268613
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/04/2015
• Event Location: Hospital
• Date Report to Manufacturer: 05/21/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/04/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: EZ-190CM FILTER WIRE WAS IN PLACE AT TIME
• Patient Age: 70 YR
• Patient Weight: 101