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

Model Number	H7493942824500
Medical Device Problem Codes	Entrapment of Device (1212); Nonstandard Device (1420); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/21/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that device entrapment and balloon detachment occurred.The target lesion was located in a coronary artery.A 5.00 x 24mm synergy megatron drug-eluting stent was advanced for treatment and deployed without difficulty.During withdrawal, as the balloon was pulled back into the guide, it became stuck in the distal guide.As the physician began to pull the device out, the balloon was separated from the delivery shaft, remaining in the guide catheter.A trapping balloon was used to secure the dislodged balloon in the guide catheter, and the guide catheter was successfully removed along with the dislodged balloon.There were no patient complications while removing the dislodge balloon and the case was completed with success.Patient was fully recovered.
Event or Problem Description
It was reported that device entrapment and balloon detachment occurred.The target lesion was located in a coronary artery.A 5.00 x 24mm synergy megatron drug-eluting stent was advanced for treatment and deployed without difficulty.During withdrawal, as the balloon was pulled back into the guide, it became stuck in the distal guide.As the physician began to pull the device out, the balloon was separated from the delivery shaft, remaining in the guide catheter.A trapping balloon was used to secure the dislodged balloon in the guide catheter, and the guide catheter was successfully removed along with the dislodged balloon.There were no patient complications while removing the dislodge balloon and the case was completed with success.Patient was fully recovered.It was further reported that the balloon was deflated prior to the initial attempt to withdraw the device was about 2-3 seconds and was fully deployed/expanded during stent deployment.
Additional Manufacturer Narrative
Device evaluated by mfr.: a synergy megatron mr us 5.00 x 24mm stent delivery system (sds) was returned for analysis.Visual and tactile inspection revealed multiple kinks along the hypotube shaft.A break was identified in the midshaft, 5mm from the port exchange.The midshaft was also stretched along the lasercut section to the break point.The balloon was subjected to positive pressure however no tears or damages were visible.The inner lumen was stretched and accordioned, 64mm from the distal tip of the device.Further stretching was noted on the shaft polymer extrusion just distal to the port exchange.Bumper tip showed no signs of distal tip damage.
Event or Problem Description
It was reported that device entrapment and balloon detachment occurred.The target lesion was located in a coronary artery.A 5.00 x 24mm synergy megatron drug-eluting stent was advanced for treatment and deployed without difficulty.During withdrawal, as the balloon was pulled back into the guide, it became stuck in the distal guide.As the physician began to pull the device out, the balloon was separated from the delivery shaft, remaining in the guide catheter.A trapping balloon was used to secure the dislodged balloon in the guide catheter, and the guide catheter was successfully removed along with the dislodged balloon.There were no patient complications while removing the dislodge balloon and the case was completed with success.Patient was fully recovered.It was further reported that the balloon was deflated prior to the initial attempt to withdraw the device was about 2-3 seconds and was fully deployed/expanded during stent deployment.

• 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: 23759223
• Report Number: 2124215-2025-89881
• Device Sequence Number: 10117562
• Product Code: NIQ
• UDI-Device Identifier: 08714729985723
• UDI-Public: (01)08714729985723(17)260403(10)33856352
• Combination Product (Y/N): Y
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P150003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/16/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/03/2026
• Device Model Number: H7493942824500
• Device Catalogue Number: H7493942824500
• Device Lot Number: 0033856352
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/21/2025
• Supplement Date Received by Manufacturer: 12/08/2025; 01/19/2026
• Initial Report FDA Received Date: 12/09/2025
• Supplement Report FDA Received Date: 12/29/2025; 02/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/03/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown