MAUDE Adverse Event Report: BOSTON SCIENTIFIC SYNERGY; STENT

Lot Number 19633070

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Foreign Body In Patient (2687)

Event Date 11/28/2016

Event Type  Injury  

Event Description

During pci, stent dislodged from scaffolding and come off in circ.After multiple attempts at retrieval, the stent was crushed into the wall of the vessel.No adverse outcomes with pt.

• Brand Name: SYNERGY
• Type of Device: STENT
• Manufacturer (Section D): BOSTON SCIENTIFIC
• MDR Report Key: 6199049
• MDR Text Key: 63216129
• Report Number: MW5066859
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 12/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 19633070
• Was Device Available for Evaluation?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 74 YR
• Patient Weight: 104