MAUDE Adverse Event Report: BOSTON SCIENTIFIC SYNERGY MONIRAIL STENT

Model Number SYNERGY MONIRAIL

Device Problem Material Deformation (2976)

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

Event Date 12/27/2016

Event Type  malfunction  

Event Description

While setting up for the procedure using a synergy monorail stent it was noted that the stent had deformed struts on the proximal end.Product not used.Another stent was opened for the case.Did not reach the patient was noted during set up.

• Brand Name: SYNERGY MONIRAIL STENT
• Type of Device: SYNERGY MONIRAIL STENT
• Manufacturer (Section D): BOSTON SCIENTIFIC
• MDR Report Key: 6215320
• MDR Text Key: 63730125
• Report Number: MW5066983
• Device Sequence Number: 1
• Product Code: NIQ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/27/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/09/2017
• Device Model Number: SYNERGY MONIRAIL
• Device Catalogue Number: H7493926024300
• Device Lot Number: 19716257
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1