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

Model Number	H7493942816500
Health Effect - Clinical Code	Cyanosis (1798)
Date of Event	07/10/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The pt was admitted to hospital cardiac cath lab for a right heart percutaneous procedure.During the procedure, the balloon ruptured with resulting lack of deployment of the stent, which remained in the left subclavian artery.The pt became severely cyanotic and was emergently transferred to the operating room for life saving intervention.Pt brought back to or on [redacted] for removal of the retained stent and vascular repair.

• Brand Name: SYNERGY MEGATRON¿
• Common Device Name: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 24495652
• Report Number: 24495652
• Device Sequence Number: 10684809
• Product Code: NIQ
• UDI-Device Identifier: 08714729985648
• UDI-Public: (01)08714729985648
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 01/20/2026
• Report Date (Section F): 01/20/2026

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?: No
• Operator of Device: Health Professional
• Device Model Number: H7493942816500
• Device Catalogue Number: H7493942816500
• Device Lot Number: 35355636
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Device Age: 8 MO
• Event Location: Hospital
• Date Report to Manufacturer: 03/03/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/03/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Life Threatening; Required Intervention
• Patient Age: 4 YR
• Patient Sex: Female
• Patient Weight: 13 KG
• Date Report Sent to FDA: 01/20/2026