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

Model Number	H7493942832400
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/15/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Good faith effort attempts were made to try and retrieve additional details regarding the reported event, but further information was unable to be obtained.
Event or Problem Description
It was reported that stent moved on balloon occurred.A 4.00 x 32mm synergy megatron drug-eluting stent was selected for treatment.However, during insertion, the balloon got displaced while being positioned in the artery.The device was then replaced, and the procedure was completed.There were no patient complications reported.
Additional Manufacturer Narrative
B5.Describe event or problem updated.
Event or Problem Description
It was reported that stent moved on balloon occurred.A 4.00 x 32mm synergy megatron drug-eluting stent was selected for treatment.However, during insertion, the balloon got displaced while being positioned in the artery.The device was then replaced, and the procedure was completed.There were no patient complications reported.It was further reported via user medwatch (b)(4) that the device was removed.
Additional Manufacturer Narrative
B5.Describe event or problem updated.
Event or Problem Description
It was reported that stent moved on balloon occurred.A 4.00 x 32mm synergy megatron drug-eluting stent was selected for treatment.However, during insertion, the balloon got displaced while being positioned in the artery.The device was then replaced, and the procedure was completed.There were no patient complications reported.It was further reported via user medwatch (b)(4) that the device was removed.

• Brand Name: SYNERGY MEGATRON?
• Common Device Name: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: mark mischke ; 4100 hamline ave n; arden hills, MN 55112 ; 7634941632
• MDR Report Key: 22994734
• Report Number: 2124215-2025-61402
• Device Sequence Number: 9620083
• Product Code: NIQ
• UDI-Device Identifier: 08714729985785
• UDI-Public: (01)08714729985785(17)270127(10)35801761
• Combination Product (Y/N): Y
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: P150003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/10/2026

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 Model Number: H7493942832400
• Device Catalogue Number: H7493942832400
• Device Lot Number: 0035801761
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/15/2025
• Supplement Date Received by Manufacturer: 10/02/2025; 02/10/2026
• Initial Report FDA Received Date: 09/08/2025
• Supplement Report FDA Received Date: 10/27/2025; 02/10/2026
• Date Device Manufactured: 01/27/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown