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

Model Number	H7493942812500
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/12/2023
Type of Reportable Event	Malfunction
Event or Problem Description
After deploying the stent and post deployment inflation, the balloon would not wrap back down to fit through the guide.

• Brand Name: SYNERGY MEGATRON MONORAIL CORONARY STENT
• Common Device Name: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; marlborough MA 01752
• MDR Report Key: 18031683
• Report Number: MW5147431
• Device Sequence Number: 15464253
• Product Code: NIQ
• UDI-Device Identifier: 08714729985600
• UDI-Public: 08714729985600
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 10/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/16/2024
• Device Model Number: H7493942812500
• Device Lot Number: 31761122
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/27/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown