MAUDE Adverse Event Report: BOSTON SCIENTIFIC SYNERGY; SYNERGY CORONARY STENT

Model Number SYNERGY

Device Problems Detachment Of Device Component (1104); Material Frayed (1262)

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

Event Date 02/21/2016

Event Type  Injury  

Event Description

Synergy stent 3.0 x 12mm ref no: (b)(4), lot no: 18571589.This stent released from the balloon prior to being deployed, floated to the subclavian and had to be retrieved with a retrieval device, procedure date: (b)(6) 2016, dr.(b)(6), synergy stent 2.25 x 16mm, ref no: (b)(6), lot no: 18463936 on table, but never went in the body.Stent appeared to have come part way off the balloon while on the back table.A second 2.25 x 16 was then used without incident.Company notified.Procedure date: (b)(6) 2015 dr.(b)(6), synergy stent 3.0 x 28mm, ref.No: (b)(4), lot no: 18386132 pulled for case, but not used.Stent was frayed so a 2nd stent same size was pulled and used without incident.Company notified.Diagnosis or reason for use: blockage of coronary artery.

• Brand Name: SYNERGY
• Type of Device: SYNERGY CORONARY STENT
• Manufacturer (Section D): BOSTON SCIENTIFIC
• MDR Report Key: 5566939
• MDR Text Key: 42489429
• Report Number: MW5061590
• 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: 04/06/2016
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SYNERGY
• Device Catalogue Number: 39260-1230
• Device Lot Number: 18571589
• 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
• Patient Outcome(s): Required Intervention