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

Model Number 087147269840190

Device Problem Human-Device Interface Problem (2949)

Patient Problem Failure of Implant (1924)

Event Date 04/08/2017

Event Type  Injury  

Event Description

Difficulty with stent and stent was removed.

• Brand Name: SYNERGY
• Type of Device: CORONARY DRUG ELUTING STENT
• Manufacturer (Section D): BOSTON SCIENTIFIC
• MDR Report Key: 6540553
• MDR Text Key: 74399012
• Report Number: MW5069510
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/02/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/21/2017
• Device Model Number: 087147269840190
• Device Catalogue Number: H7493926020400
• Device Lot Number: 19909170
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• 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: 64 YR