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

Model Number	H7493942812350
Medical Device Problem Codes	Break (1069); Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/17/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that shaft break occurred.The 80% stenosed target lesion was located in the mildly tortuous and mildly calcified ostial circumflex artery.A 3.50 x 12mm synergy megatron? drug-eluting stent was advanced for treatment.However, during the procedure, the shaft was bent and the internal lumen was fractured, resulting in contrast leakage upon inflation.The procedure was completed with another megatron 3.5 16 mm des.There were no patient complications reported and the patient was fully recovered.
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.
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.Media review analysis: a photo was attached to the complaint record.A partial section of the hypotube was visible being inserted into the protective hoop.The photo showed evidence of a kink in the hypotube kinks were visible in the hypotube.
Event or Problem Description
It was reported that shaft break occurred.The 80% stenosed target lesion was located in the mildly tortuous and mildly calcified ostial circumflex artery.A 3.50 x 12mm synergy megatron? drug-eluting stent was advanced for treatment.However, during the procedure, the shaft was bent and the internal lumen was fractured, resulting in contrast leakage upon inflation.The procedure was completed with another megatron 3.5 16 mm des.There were no patient complications reported and the patient was fully recovered.

• 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: 23678005
• Report Number: 2124215-2025-87820
• Device Sequence Number: 18742264
• Product Code: NIQ
• UDI-Device Identifier: 08714729985570
• UDI-Public: (01)08714729985570(17)260902(10)34851264
• Combination Product (Y/N): Y
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/21/2025

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: 09/02/2026
• Device Model Number: H7493942812350
• Device Catalogue Number: H7493942812350
• Device Lot Number: 0034851264
• 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: 11/17/2025
• Supplement Date Received by Manufacturer: 12/11/2025
• Initial Report FDA Received Date: 12/01/2025
• Supplement Report FDA Received Date: 12/21/2025
• Date Device Manufactured: 09/02/2024
• 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
• Patient Age: 49 YR
• Patient Sex: Female