MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SYNERGY?; BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM

Model Number	H7493926020250
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Angina (1710); Restenosis (4576)
Date of Event	10/22/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that unstable angina occurred.On (b)(6) 2019, a 2.50 mm x 20 mm synergy drug eluting stent (des) was implanted in the mid left anterior descending artery (lad).Additionally, a 3 x 20 mm synergy stent was implanted in proximal lad.On (b)(6) 2021, the patent presented with unstable angina.The target lesion was located at the mid lad and was 15 mm long with a reference vessel diameter was 3.0 mm.The target lesion was predilated with a 2.5 mm x 20 mm balloon angioplasty catheter and laser catheter, resulting into 0% residual stenosis and timi flow of 3.Following pre-dilation, the lesion was treated with a 3.00 mm x 20 mm agent dcb study device successfully with 0% residual stenosis and timi flow of 3.The patient was discharged on aspirin and ticagrelor.
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.

• Brand Name: SYNERGY?
• Common Device Name: BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM
• 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: 21930148
• Report Number: 2124215-2025-26822
• Device Sequence Number: 18413702
• Product Code: NIQ
• UDI-Device Identifier: 08714729840152
• UDI-Public: (01)08714729840152
• 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: 2019
• 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): 04/29/2025

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: H7493926020250
• Device Catalogue Number: H7493926020250
• 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
• Initial Report FDA Received Date: 04/29/2025
• 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: 55 YR
• Patient Sex: Male
• Patient Race: Black Or African American