MAUDE Adverse Event Report: BOSTON SCIENTIFIC SYNERGY DRUG ELUTING STENT; CORONARY DRUG - ELUTING STENT

Model Number SYNERGY

Device Problems Sticking (1597); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/15/2016

Event Type  malfunction  

Event Description

A synergy stent failed to cross a lad lesion.Upon removal it was noted that two of the struts were deformed and sticking out.The vendor was present and knows of the strut deformation.The product was discarded.No patient harm.This was a longer calcified lad lesion, but it would have expected the deformation to be on the distal struts, not on the proximal which indicates that the damage occurred when removing the device.Diagnosis or reason for use: coronary artery disease lad.

• Brand Name: SYNERGY DRUG ELUTING STENT
• Type of Device: CORONARY DRUG - ELUTING STENT
• Manufacturer (Section D): BOSTON SCIENTIFIC
• MDR Report Key: 5383823
• MDR Text Key: 36656843
• Report Number: MW5059481
• 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: 01/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2016
• 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: H7493926038220
• Device Lot Number: 18411447
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 59 YR