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

Model Number	H7493942820400
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Angina (1710); Chest Pain (1776); Dyspnea (1816); Myocardial Infarction (1969); Restenosis (4576)
Date of Event	01/16/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Detailed product information was not provided to bsc.Because the product is unknown, we are unable to provide the unique identifier (udi) # and other specific product information.
Event or Problem Description
It was reported that restenosis occurred.On (b)(6) 2023, the patient presented with myocardial infarction and was treated with a 4.0 mm x 20 mm synergy megatron drug eluting stent (des) implanted in saphenous vein graft to obtuse marginal artery (svg to om graft).On (b)(6) 2025, the patient started experiencing symptoms associated with unstable angina.At the time of the event the subject was on aspirin and ticagrelor.Coronary angiography revealed 70 to 80% in stent restenosis (isr) at the svg to om.The left circumflex artery and the 100% stenosed left main were treated with percutaneous coronary intervention and discharged.On (b)(6) 2025, the patient presented to the emergency department with chest pain and dyspnea for which amio bolus and amio gtt was given and was admitted to the hospital on the same day for further evaluation treatment.The patient was diagnosed with acute myocardial ischemia/infarction.On (b)(6) 2025, in stent restenosis (isr) at om was treated with a des.Event was considered resolved and the patient was discharged.
Additional Manufacturer Narrative
Detailed product information was not provided to bsc.Because the product is unknown, we are unable to provide the unique identifier (udi) # and other specific product information.
Event or Problem Description
It was reported that restenosis occurred.On (b)(6) 2023, the patient presented with myocardial infarction and was treated with a 4.0 mm x 20 mm synergy megatron drug eluting stent (des) implanted in saphenous vein graft to obtuse marginal artery (svg to om graft).On (b)(6) 2025, the patient started experiencing symptoms associated with unstable angina.At the time of the event the subject was on aspirin and ticagrelor.Coronary angiography revealed 70 to 80% in stent restenosis (isr) at the svg to om.The left circumflex artery and the 100% stenosed left main were treated with percutaneous coronary intervention and the subject was discharged.On (b)(6) 2025, the patient presented to the emergency department with chest pain and dyspnea for which amio bolus and amio gtt was given and was admitted to the hospital on the same day for further evaluation treatment.The patient was diagnosed with acute myocardial ischemia/infarction.On (b)(6) 2025, in stent restenosis (isr) at om was treated with a des.Event was considered resolved and the patient was discharged.It was further reported that on (b)(6) 2025, the patient started experiencing symptoms associated with chest pain.On (b)(6) 2025, the patient presented to hospital with chest pain.Based on the symptoms and diagnostics, the subject was diagnosed with myocardial infarction.

• 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 IRELAND LIMITED; ballybrit business park; galway ; EI
• Manufacturer Contact: mark mischke ; 4100 hamline ave n; arden hills, MN 55112 ; 7634941632
• MDR Report Key: 21930116
• Report Number: 2124215-2025-26820
• Device Sequence Number: 18413698
• Product Code: NIQ
• UDI-Device Identifier: 08714729985662
• UDI-Public: (01)08714729985662
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P150003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/03/2025

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?: No
• Operator of Device: Health Professional
• Device Model Number: H7493942820400
• Device Catalogue Number: H7493942820400
• 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: 04/07/2025
• Supplement Date Received by Manufacturer: 05/09/2025
• Initial Report FDA Received Date: 04/29/2025
• Supplement Report FDA Received Date: 06/03/2025
• 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: Hospitalization; Required Intervention
• Patient Age: 55 YR
• Patient Sex: Male
• Patient Race: Black Or African American