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

Model Number	H7493942824500
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/26/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported via user medwatch mw5184787 that stent fracture occurred requiring additional intervention.A 5.00 x 24mm synergy megatron drug-eluting stent (des) was selected for treatment.The stent was advanced through the vessel; however, when pulling out the stent, it broke in the vessel.A snare device was used to successfully retrieve the detached segment.No patient complications were reported.No further information is available.
Additional Manufacturer Narrative
Investigation results: device analysis findings: the device was not returned for analysis; therefore, a technical analysis could not be performed.Device history record (dhr) review: it was confirmed that this device met manufacturing specification prior to distribution and there no manufacturing deviations which could have contributed to the reported event.Labeling review: review of the instructions for use (ifu) confirmed there was relevant content and sufficient guidance with respect to the circumstances described within this complaint.No updates are required to the ifu as a result of this event.Risk review: a risk review was performed, and it confirmed that the event was defined in the risk documentation and is recorded accordingly in the product record review (prr) table.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.Investigation conclusion: this investigation is assigned a most probable investigation conclusion code of cause not established based on the available information as well as unavailability of the device for analysis.This code was selected as the most probable complaint cause based on the information available.The reported event could not be confirmed as the device was not returned for analysis.Without imaging or photos of the allegation a clear conclusion cannot be established as to why the stent fractured during the procedure.
Event or Problem Description
It was reported via user medwatch mw5184787 that stent fracture occurred requiring additional intervention.A 5.00 x 24mm synergy megatron drug-eluting stent (des) was selected for treatment.The stent was advanced through the vessel; however, when pulling out the stent, it broke in the vessel.A snare device was used to successfully retrieve the detached segment.No patient complications were reported.Not further information is available.

• 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: 25015212
• Report Number: 2124215-2026-22793
• Device Sequence Number: 15861118
• Product Code: NIQ
• UDI-Device Identifier: 08714729985723
• UDI-Public: (01)08714729985723(17)270521(10)36663882
• Combination Product (Y/N): Y
• Initial Reporter State: MA
• 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
• Report Date (Section B): 05/28/2026

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 Model Number: H7493942824500
• Device Catalogue Number: H7493942824500
• Device Lot Number: 0036663882
• 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: 04/06/2026
• Supplement Date Received by Manufacturer: 05/12/2026
• Initial Report FDA Received Date: 04/28/2026
• Supplement Report FDA Received Date: 05/28/2026
• Date Device Manufactured: 05/21/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 79 YR
• Patient Sex: Male
• Patient Weight: 132 KG
• Patient Race: White