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

Model Number	H7493942824400
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Angina (1710); Restenosis (4576)
Date of Event	08/22/2025
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 angina and in-stent restenosis occurred.On (b)(6) 2024, in-stent restenosis in the proximal right coronary artery (rca) was treated with a 4.00 x 24 mm synergy megatron everolimus-eluting stent.On (b)(6) 2025, the patient presented to the hospital with symptoms of recurrent angina.At the time of event the patient was on aspirin and clopidogrel, which were continued.The patient was diagnosed with coronary artery disease.Coronary angiography revealed a 70% in-stent restenosis at the proximal rca.A 70% in stent restenosis at proximal rca extending to mid rca due to neo intimal hyperplasia was noted and was initially treated with a cutting balloon and further successfully treated with an nc balloon and brachytherapy.Post revascularization, the residual stenosis was noted as 30% with timi flow 3.The event was considered as recovered/resolved.

• 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: 23586223
• Report Number: 2124215-2025-84235
• Device Sequence Number: 9305151
• Product Code: NIQ
• UDI-Device Identifier: 08714729985709
• UDI-Public: (01)08714729985709
• Combination Product (Y/N): Y
• Initial Reporter State: OH
• 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: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/18/2025

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: H7493942824400
• Device Catalogue Number: H7493942824400
• 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: 10/27/2025
• Initial Report FDA Received Date: 11/18/2025
• 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 Age: 49 YR
• Patient Sex: Male
• Patient Race: White